RESEARCH

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Original Research

Diabetes Nurse Case Management in a Canadian Tertiary Care Setting:
Results of a Randomized Controlled Trial

Danni Li MD a, Tom Elliott MBBS a,b, Gerri Klein RN, CDE a,b, Ehud Ur MBBS a, Tricia S. Tang PhD a,*
a Division of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
b BC Diabetes, Vancouver, British Columbia, Canada

a r t i c l e i n f o

Article history:
Received 2 May 2016
Received in revised form
17 October 2016
Accepted 21 October 2016

Keywords:
diabetes nurse case manager
randomized controlled trial
tertiary care setting
diabetes distress
psychosocial outcomes

a b s t r a c t

Objectives: To examine the effects of a 6-month nurse case manager (NCM) intervention compared to stan-
dard care (SC) on glycemic control and diabetes distress in a Canadian tertiary-care setting.
Methods: We recruited 140 adults with type 2 diabetes and glycated hemoglobin (A1C) levels >8%
(64 mmol/mol) from 2 tertiary care facilities and randomized them to: 1) a 6-month NCM intervention
in addition to SC or 2) SC by the primary endocrinologists. Assessments were conducted at baseline and
at 6 months. Primary outcomes included A1C levels and diabetes distress scores (DDS). Secondary out-
comes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symp-
toms, self-motivation and perception of support.
Results: At the 6-month follow up, the NCM group experienced larger reductions in A1C levels of −0.73%
compared to the SC group (p=0.027; n=134). The NCM group also showed an additional reduction of −0.40
(26% reduction) in DDS compared to those in the SC group (p=0.001; n=134). The NCM group had lower
blood pressure, ate more fruit and vegetables, exercised more, checked their feet more frequently, were
more motivated, were less depressed and perceived more support. There were no changes and no group
differences in terms of body mass index, medication compliance or frequency of testing.
Conclusions: Compared to SC, NCM intervention was more effective in improving glycemic control and
reducing diabetes distress. It is, therefore, a viable adjunct to standard diabetes care in the tertiary care
setting, particularly for patients at high risk and with poor control.

Mots clés :
infirmière gestionnaire de cas de diabète
essai clinique à répartition aléatoire
cadre des soins tertiaires
détresse liée au diabète
critères de jugement psychosociaux

r é s u m é

Objectifs : Examiner les effets de l’intervention de 6 mois d’une infirmière gestionnaire de cas (IGC) par
rapport aux effets des soins courants (SC) sur la régulation de la glycémie et la détresse liée au diabète
dans le cadre canadien des soins tertiaires.
Méthodes : Nous avons recruté 140 adultes atteints du diabète de type 2 qui avaient des concentrations
d’hémoglobine glyquée (A1c)>8% (64 mmol/mol) de 2 établissements de soins tertiaires et les avons répartis
de manière aléatoire comme suit : 1) intervention de 6 mois d’une IGC en plus des SC ou 2) SC par les
endocrinologues traitants. Les évaluations ont été réalisées au début et après 6 mois. Les critères de jugement
principaux étaient les concentrations de l’A1c et les scores de la détresse liée au diabète (SDD). Les critères
secondaires étaient les suivants : l’indice de masse corporelle, la pression artérielle, les mesures du
comportement lié au diabète, les symptômes de dépression, la motivation personnelle et la perception
du soutien.
Résultats : Au suivi après 6 mois, le groupe IGC montrait des réductions plus grandes des concentrations
de l’A1c de −0,73% que celles du groupe SC (p=0,027; n=134). En plus, le groupe IGC montrait une réduction
des SDD de −0,40 (réduction de 26%) par rapport au groupe SC (p=0,001; n=134). Les adultes du groupe
IGC avaient une pression artérielle plus basse, mangeaient plus de fruits et de légumes, faisaient plus
d’exercice, vérifiaient leurs pieds plus fréquemment, étaient plus motivés, étaient moins dépressifs et
s’apercevaient d’un plus grand soutien. Il n’y avait aucun changement et aucune différence entre les groupes
en ce qui concerne l’indice de masse corporelle, l’observance thérapeutique ou la fréquence des analyses.

* Address for correspondence: Tricia S. Tang, PhD, University of British Columbia, 2775 Laurel Street, Suite 10211, Vancouver, British Columbia, Canada V5Z 1M9.
E-mail address: tricia.tang@vch.ca

Can J Diabetes 41 (2017) 297–304

Contents lists available at ScienceDirect

Canadian Journal of Diabetes
j o u r n a l h o m e p a g e :

w w w. c a n a d i a n j o u r n a l o f d i a b e t e s . c o m

1499-2671 © 2017 Canadian Diabetes Association.
The Canadian Diabetes Association is the registered owner of the name Diabetes Canada.
http://dx.doi.org/10.1016/j.jcjd.2016.10.012

Downloaded for Anonymous User (n/a) at University of Virginia from ClinicalKey.com by Elsevier on March 07, 2021.
For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.

mailto:tricia.tang@vch.ca

http://dx.doi.org/10.1016/j.jcjd.2016.10.012

http://www.sciencedirect.com/science/journal/14992671

http://crossmark.crossref.org/dialog/?doi=10.1016/j.jcjd.2016.10.012&domain=pdf

Conclusions : Comparativement aux SC, l’intervention d’une IGC était plus efficace pour améliorer la régulation
de la glycémie et réduire la détresse liée au diabète. Par conséquent, il s’agit d’un complément viable aux
soins courants offerts aux diabétiques dans le cadre des soins tertiaires, particulièrement chez les patients
exposés à un risque élevé qui ont une régulation médiocre.

Introduction

The prevalence of diabetes is rising worldwide, primarily because
of an aging and increasingly obese population. In 2010, 2.7 million
(7.6%) people in Canada were diagnosed with diabetes, and this
number is projected to reach 4.2 million (10.8%) by 2020 (1). Dia-
betes and its associated complications are a significant burden on
the Canadian economy, costing $11.7 billion in 2010 and expected
to rise to $16 billion by 2020 (1).

Despite compelling evidence that tight glucose control can
prevent or delay complications (2), outcomes are poor, and improve-
ments are needed. For instance, among 3002 Canadian patients in
a primary care setting, Braga et al (3) found that 30%, 39% and 53%
achieved treatment targets for blood pressure (BP), glycated hemo-
globin (A1C) and cholesterol, respectively. Moreover, only 7%
achieved all 3 goals. Clearly, greater efforts are needed to help
patients improve diabetes-related health outcomes in Canada.

Among the various models investigated to improve diabetes care
delivery, case management has produced the most favourable evi-
dence (4,5). In fact, a meta-analysis of 11 different quality-
improvement strategies for diabetes care found that interventions
involving case-management strategies led to the greatest reduc-
tions in A1C levels (5). Case management encompasses the assess-
ment, implementation, coordination and monitoring of options and
services required to meet individual health needs (6). It can include
patients’ education, coaching, treatment adjustment, monitoring and
care coordination (7).

Several systematic and integrative reviews have shown diabe-
tes case management interventions to be effective in improving gly-
cemic control (6–10) by up to 0.89% (6). In addition, a study of 556
patients receiving care in a Veteran Affairs healthcare system found
that, compared to controls, a greater proportion of patients ran-
domized to a nurse case manager (NCM) intervention achieved the
collective treatment target for A1C levels, BP and low-density lipo-
protein levels (11).

Although there is overwhelming evidence supporting NCM
models in the treatment of diabetes, these studies have been con-
ducted predominantly in primary care and community-based set-
tings in the United States and Europe (6). In fact, of the 29 case
management studies in the meta-analysis of Welch et al (6), only
1 study was conducted with patients attending a tertiary care clinic
in Canada. That randomized controlled trial of 46 patients with dia-
betes found a significant reduction in A1C levels associated with a
telephone-based nursing intervention compared to standard care
conditions (12). However, the study recruited patients with both
type 1 and type 2 diabetes requiring insulin, and it focused on insulin
titration to the exclusion of other core self-management issues, such
as healthful eating, physical activity and psychosocial well-being.
To our knowledge, no studies of NCM-assisted patients with dia-
betes have been conducted in a Canadian tertiary care setting that
focus on comprehensive care of patients with type 2 diabetes only
who are being treated with oral agents and/or insulin.

The current study is the first randomized controlled trial (RCT)
to evaluate the impact of NCM intervention for patients with poorly
controlled type 2 diabetes who were recently discharged from 2 ter-
tiary care hospitals in Canada or referred by tertiary hospital-
affiliated endocrinologists. In addition, this Canadian-based study
is the first to include both a primary clinical outcome (A1C levels)
and a psychosocial outcome (diabetes distress).

Methods

Study design, setting and population

This study was approved by the University of British Columbia
and Providence Health Clinical Research Ethics Boards. It is an RCT
of a 6-month NCM intervention compared to standard care (SC). The
study was initiated in September 2012, enrollment was com-
pleted in July 2014, and follow up was completed in January 2015.
The protocol is viewable at https://clinicaltrials.gov/ct2/show/
NCT01659294.

The study was conducted at BCDiabetes.ca, based in the Gordon
and Leslie Diamond Health Care Centre. The centre is the main ter-
tiary care centre in Vancouver, British Columbia, and brings together
outpatient services at Vancouver General Hospital, including spe-
cialty clinics, along with medication education, physician teach-
ing clinics and research, at a single site.

Inclusion/exclusion criteria

To be eligible for the study, patients had to 1) have physician-
diagnosed type 2 diabetes; 2) be ≥18 years of age; (3) have A1C levels
≥8% and 4) to be able to read and write English. Patients were
excluded if they had previously worked with an NCM or had any
serious health conditions (e.g. terminal cancer), serious psychiat-
ric illness or self-reported excessive alcohol or illicit drug use that
would impede meaningful participation in the study.

Recruitment

Study participants were recruited using 2 streams: 1) patients
who had been recently discharged from 2 tertiary care hospitals in
Vancouver (Vancouver General Hospital or St. Paul’s Hospital) and
2) patients referred by endocrinologists affiliated with the 2 ter-
tiary care hospitals. If recruited from the hospital, the invitation to
participate in the study was made by a member of the treating endo-
crine team (endocrinology fellow or resident). The primary endo-
crinologist or the member of the team briefly described the study
and its eligibility criteria. The NCM contacted interested patients
and scheduled initial visits during which she described the study
in greater detail, obtained informed consent and conducted base-
line assessments. In the case of outpatient referrals, the invita-
tions came from the treating endocrinologist. These patients had
been referred to the treating endocrinologist by their community-
based family (primary) physician. All potential subjects who met
the study entry criteria were approached by treating endocrinolo-
gists to participate in the study. As such, participants were repre-
sentative of new diabetes referrals (with A1C levels >8.0) seen by
the referring endocrinologists.

Randomization process

Each participant was randomly assigned to the intervention or
control group by using a stratified permuted block randomization
scheme, with the endocrinologist being the sole stratification factor.
The permuted block aspect of the randomization scheme ensured
that treatment assignment remained balanced throughout the enrol-
ment period. Randomized assignments were completed in advance
and kept in individual, sealed, sequentially labelled envelopes that
were opened at the time of the randomization of each participant.

D. Li et al. / Can J Diabetes 41 (2017) 297–304298

https://clinicaltrials.gov/ct2/show/NCT01659294

Nurse case manager intervention

Nurse case management was conducted by a single individual,
GK, a certified diabetes educator with a master’s degree in nursing
and 37 years of nursing experience. The nurse received informal
in-house diabetes training by working with 1 of the endocrinologists.

The general principle (although not the exact framework) used
by the NCM was the Empowerment and Self-Management model
developed by Funnell and Anderson (13).

NCM intervention was an adjunct to standard care. Partici-
pants in the NCM group received a 60-minute initial consultation
with the NCM, followed by contact via telephone or e-mail or in
person at a minimum of every other week initially and, thereaf-
ter, as each participant warranted. The purpose of follow-up contact
was to monitor participants’ diabetes control, risk factors and man-
agement goals and to recommend treatment additions or modifi-
cations where desirable. There were 3 core components of the NCM
intervention: 1) diabetes self-management education and support;
2) monitoring and algorithm-driven treatment adjustment; and 3)
care coordination with other health professionals.

Diabetes education
A brief education-needs assessment was made. All partici-

pants were asked to talk about their conditions and to say what they
felt had contributed to their diagnoses and what had helped them
to handle their diabetes and what had not. Participants were asked
to read information that was given and then to explain what they
had read in their own words.

During the initial consultation prior to randomization, the NCM
delivered diabetes education and provided supplementary written
literature to patients.

Broad topics included the process of diabetes, health behaviour
changes, healthful eating, physical activity and the role of medi-
cation, the meaning of A1C levels, the role of blood glucose moni-
toring, short- and long-term complications, stress and coping.
Whenever participants were prescribed sulfonylureas and/or insulin,
they were educated in the concept of purposeful blood glucose moni-
toring (target driven) and were given home blood glucose moni-
tors and 10 strips.

All of the NCM participants were asked what their target goals
were: blood glucose, exercise, weight (and smoking cessation if rel-
evant) and where they felt comfortable. Informal contracts between
participants and educators were discussed and implemented, either
in writing in the nursing notes or verbally, laying out a plan of what
the participants and nurses were to do.

Participants were given diabetes-related information in their
mother tongue where possible. Literacy was evaluated at consent,
when the participants were asked to read the consent form and
restate them in their own words. Some could not read English at
the level required for understanding and, therefore, were not given
written diabetes information. Picture-based materials from the Cana-
dian Diabetes Association were offered to those who appeared to
benefit from such materials. Those able to read at sufficient levels
of understanding were given written diabetes-related informa-
tion from the Canadian Diabetes Association and BCDiabetes.ca; free
literature from local big-chain pharmacies was offered; when appro-
priate, participants were given the book Understand Your Diabetes
(14).

Discussions where initiated about what was good information
and what was not so good. Other Internet sources were accessed
and discussed as ways of discovering what to believe and what not
to listen to.

Monitoring and algorithm-driven treatment adjustment
Participants randomized to the NCM cohort were reviewed by

the NCM at intervals determined and driven by the results of

purposeful blood glucose monitoring; glucose targets were deter-
mined by the referring endocrinologist. Participants were instructed
by the NCM to communicate their blood glucose monitoring results
by e-mail or phone. The NCM offered feedback and intervention
when they were considered appropriate. Blood pressure readings
and targets were discussed with participants; when medication
adjustments were considered desirable, the NCM communicated
directly with the endocrinologist. With respect to insulin adjust-
ment, the NCM independently adjusted insulin according to the fol-
lowing algorithms: 1) for once-daily basal insulin adjustment, target
fasting glucose levels were 5 mmol/L to 7 mmol/L. Patients were
encouraged to make daily adjustments in dose (default incre-
ments of 2 U for above-target and decrements of 4 U for below target,
no change for to-target values); 2) for twice-daily basal insulin,
fasting glucose targets were used to adjust evening insulin doses,
and evening blood glucose targets were used to adjust morning
insulin doses (same adjustment parameters as those for once-
daily basal insulin); 3) for prandial rapid insulin, participants were
asked to test before and 2 hours after meals; the before-meal targets
were 5 mmol/L to 7 mmol/L, and the 2-hour post meal targets were
5 mmol/L to 10 mmol/L. The NCM reviewed the concept of carbo-
hydrate counting and iterated the carbohydrate-to-insulin ratio.

Linkage to allied healthcare services
The NCM determined the need for adjunct interventions. When

indicated, and after consultation with endocrinologist and/or family
physicians, participants were referred to the following: outpa-
tient mental health clinics, smoking cessation clinics, physio-
therapy groups, nutrition counselling, social services and/or walking/
exercise/sports programs in the community.

Eye examination referrals were made to local expert optom-
etrists for all participants who had not had a retinal check in the
past year. Podiatric referrals were made when clinically indicated.
Specialist medical referrals for comorbid conditions were made as
necessary during the study by the treating endocrinologist.

With respect to communication between the participants and
the NCM, all participants were given the nurse’s contact informa-
tion (office phone, e-mail and, if on insulin, cell phone number).
The frequencies and dates and times of education and support were
agreed upon by the patients and the NCM. Patients who requested
more support accessed the NCM more often. The NCM would
follow up by phone or e-mail with patients new to insulin and set
up a contact schedule dependent upon patient preference and
reported blood sugar levels. Patients undergoing dose adjust-
ments contacted the NCM daily usually in the morning, with their
fasting blood sugar levels so as to gain assistance with dose adjust-
ments. However, once the patients were comfortable with the algo-
rithm, they managed their own dose adjustments independently
and contacted the NCM only for scheduled appointments. If the NCM
participant did not call at the expected time, the nurse called the
participant. After a third call by the nurse, all further calls were ini-
tiated by the participant unless for a further prearranged call.

With respect to diabetes-related distress and depression, dis-
cussion was initiated with all treatment participants about the asso-
ciation between depression and diabetes; answers to questions by
subjects in the study questionnaires were pursued. The nurse encour-
aged discussion about thoughts and feelings and about activities
the subjects enjoyed. Inquiries were made about alcohol and sub-
stance abuse and about access to counsellors or psychiatrists. Refer-
rals to psychiatrists were suggested and facilitated by the treating
endocrinologist, as necessary.

Standard care

Beyond the NCM’s arranging for the second and final visit at
6 months to collect study-specific data points, SC participants were

D. Li et al. / Can J Diabetes 41 (2017) 297–304 299

managed entirely by the referring endocrinologist, who deter-
mined treatment parameters, made changes to treatment regi-
mens and scheduled follow-up appointments according to their usual
patterns of practice.

Participation and assessment

Participants in both the NCM group and the SC group com-
pleted baseline and 6-month assessments. A week prior to these
visits, participants were instructed to have their A1C levels mea-
sured at a self-selected laboratory. If no blood had been drawn prior
to the visit, blood was drawn on the day of the visit with the NCM,
and point-of-care A1C levels were measured at the time of the visit
so as to direct clinical decision making. At the NCM visit, partici-
pants had the following measured: BP, weight and height. Partici-
pants also completed a 20-minute self-report survey. Upon
completion, participants received a stipend of $20 for their time and
effort.

Outcomes and measurements

Primary outcomes included A1C levels and diabetes distress. The
A1C levels were measured at a participant-selected laboratory that
used standard high-performance liquid chromatography methods
on a machine calibrated to the national standard (mean 5.0%, top
of normal range = 6.0%). For participants who did not obtain blood
work at a laboratory prior to baseline and the 6-month assess-
ment, the NCM performed point-of-care testing using the Bayer
DCA2000+ Analyzer (Bayer, Keverkusen, Germany) (15). Diabetes
distress was assessed using the 17-item Diabetes Distress Scale (DDS)
developed by Polonsky and colleagues (16). The DDS measures emo-
tional distress and functioning as they relate to living with diabe-
tes. Responses are scored on a 6-point Likert scale (1 = no problem
to 6 = serious problem). A total score is derived by taking the mean
of all items. A score of <2 indicates low or no distress; a score of 2 through 2.9 indicates moderate distress; and a score of ≥3 indi- cates high distress.

Secondary outcomes included clinical, behavioural and psycho-
social outcome measures.

BP was measured using an Omron Digital Blood Pressure Monitor
HEM-907 (Kyoto, Japan). Two upper-arm readings were taken, and
the average of the 2 was recorded. Height and weight were mea-
sured using the Health o meter mechanical eye-level upright stan-
dard physician’s scale with attached stadiometer (Sunbeam, Boca
Raton, Florida, United States). Body mass indexes were calculated
as weight in kilograms divided by height in metres squared.

Self-management behaviours were assessed using items from
the Summary of Diabetes Self-Care Activities Measure, revised (17).
This instrument measures self-care behaviours, including diet, exer-
cise, blood-sugar testing and foot care. Participants were asked to
report the number of days in the past week (range, 0 to 7 days)
during which they performed specific self-care practices. Greater
numbers of days indicated better self-management. Medication
adherence was assessed using the 4-item Morisky scale that assesses
beliefs and behaviours associated with taking medications (18).
Responses were scored on a dichotomous scale: 0 = no, and 1 = yes.
A total score was calculated by adding up all items; lower scores
indicated better adherence.

Participant motivation was measured by the 13-item Patient Acti-
vation Measure, which assesses participants’ self-reported knowl-
edge, skills and confidence in managing their own health (19).
Diabetes-specific social support was assessed by a 4-item scale devel-
oped by Tang et al (20) that measures the amount of support and
satisfaction with that support by family members, friends and the
healthcare team. Depressive symptom severity was assessed using
the 9-item PRIME-MD Patient Health Questionnaire (PHQ-9) (21,22).

Demographic characteristics

Demographic characteristics included age, gender, years diag-
nosed with diabetes, ethnicity, marital status, education level, income
and employment status.

Sample size and power

Based on the current literature, an A1C level difference of 0.5%
or more was considered clinically significant. To achieve 80% power
in a 1-sided 0.05-level t test, a sample size of 72 subjects per arm
was considered necessary if the true difference in A1C levels between
the NCM group and the SC group was 0.5%. This assumed a stan-
dard deviation of the difference in A1C levels between baseline and
6 months of 1.2% and that it was common to both groups (23).
Although DDS was established as an additional primary outcome
at the onset of the study, it should be noted that sample size was
calculated with only A1C levels in mind. Furthermore, many sec-
ondary outcomes were included without changes in sample size.
Recognizing the importance of well-powered studies, caution should
thus be taken in interpreting the results.

Statistical analysis

Demographic characteristics of the sample are described as means
and standard deviations if they are continuous and as counts and
percentages if they are categorical. Baseline values for demo-
graphic and clinical variables were compared between the 2 arms
to identify potential confounding variables. Categorical variables were
assessed by chi-square tests, with Monte Carlo-simulated p values
when necessary.

Because the primary outcomes (A1C levels and diabetes dis-
tress) and the secondary outcomes are continuous measures, the
assessment of whether the mean differences between the 2 groups
were statistically significant was conducted using the Student t test,
adjusting for baseline values. No adjustment for multiple testing
was made.

A modified intention-to-treat approach was used, in which data
from all participants who provided baseline and follow-up out-
comes were included and analyzed based on NCM-SC group assign-
ments, regardless of whether each individual participant received
the assigned treatment.

Results

Study sample

There were 251 patients who met the inclusion criteria, and 140
patients who consented to participate in the study (Figure 1). Six
patients did not complete baseline assessment. At the 6-month
follow up, 130 patients completed A1C measurements, and 120
patients completed the survey (attrition rate 7% and 14%, respec-
tively). Loss to follow up was not different in the 2 groups.

Participants’ characteristics

Table 1 presents the baseline demographic characteristics of the
study’s population. No significant differences were found in the NCM
and SC groups in terms of gender, ethnicity, martial status, educa-
tion level, employment status or household income (all p values
>0.08). Although various ethnic groups were involved in the study,
about half were Caucasian. The mean age of the participants was
57 years, and the mean number of years of living with diabetes was
11; 54% were married, 58% were male, 31% had high school edu-
cations or less, 54% were employed and 48% reported an annual
income of less than $50 000.

D. Li et al. / Can J Diabetes 41 (2017) 297–304300

Primary outcomes

Glycemic control
At baseline, glycemic control was inadequate for both the NCM

and the SC groups (Figure 2, Table 2). At the 6-month follow up,
both groups had achieved significant reductions in mean A1C levels

(from 10.45%±2.13% to 7.72%±1.43; p<0.01, and from 10.52%±2.08 to 8.46%±2.29; p<0.01, respectively). The NCM group experienced significantly larger reductions in A1C levels (−0.73%) (Figure 2, A) compared to the SC group (p=0.027; n=134).

Diabetes distress
At baseline, both the NCM and the SC groups had diabetes dis-

tress in the low to moderate category. At the 6-month follow up,
the NCM group had significantly lower mean DDS scores com-
pared to those found at the start of the intervention (from 1.90±0.77
to 1.37±0.38; p<0.01). This implies that the DDS score was reduced from near moderate to low. The SC group showed no change in DDS scores (from 1.92±0.84 to 1.78±0.91; p=0.23). Participants in the NCM group showed an additional reduction of −0.40 (26%) in DDS scores (Figure 2B) compared to those in the SC group (p=0.001; n=134), and all had low levels of diabetes distress at the end of the study.

Secondary outcomes

Clinical outcomes
In the NCM group, the average systolic and diastolic BP declined

by 8 mm Hg (p=0.02) and 4 mm Hg (p=0.04), respectively, from base-
line to 6 months (Table 2). The SC group did not show any improve-
ment in BP levels. There was no change in body mass indexes in
either group; they were in the obese category at baseline and at
the 6-month follow up.

Figure 1. Study flowchart. A1C, HbA1c; GP, general practitioner; NCM, nurse case man-
agement; SC, standard care.

Table 1
Demographic information concerning the modified intent-to-treat population

All
N=134

SC
n=64

NCM
n=70

Age Mean (SD) 57.43 (11.01) 58.23 (10.87) 56.69 (11.16)
Years with

diabetes
Mean 10.84 11.84 9.91
(SD) (8.24) (8.10) (8.33)

Gender Male 78 (58%) 37 (58%) 41 (59%)
Female 56 (42%) 27 (42%) 29 (41%)

Ethnicity Arabic 3 (2%) 2 (3%) 1 (1%)
Black 4 (3%) 2 (3%) 2 (3%)
Chinese 19 (14%) 5 (8%) 14 (20%)
First Nations 5 (4%) 4 (6%) 1 (1%)
South Asian 15 (11%) 9 (14%) 6 (9%)
White 65 (49%) 29 (45%) 36 (51%)
Other 23 (17%) 13 (20%) 10 (14%)

Marital
status

Never married 27 (20%) 11 (17%) 16 (23%)
Married 72 (54%) 33 (52%) 39 (57%)
Living with partner 3 (2%) 3 (5%) 0 (0%)
Separated/divorced 20 (15%) 12 (19%) 8 (12%)
Widowed 11 (8%) 5 (8%) 6 (9%)
n missing 1 (1%) 0 1 (1%)

Education Less than high school 12 (9%) 9 (14%) 3 (4%)
High school 29 (22%) 11 (17%) 18 (26%)
College/technical 32 (24%) 15 (24%) 17 (24%)
University 41 (31%) 22 (35%) 19 (27%)
Graduate degrees 19 (14%) 6 (10%) 13 (19%)
n missing 1 (1%) 1 (1%) 0

Income $20,000 30 (22%) 20 (31%) 10 (14%)
$20,000–$29,000 14 (10%) 6 (9%) 8 (11%)
$30,000–$39,000 17 (13%) 7 (11%) 10 (14%)
$40,000–$49,000 16 (12%) 10 (16%) 6 (9%)
$50,000–$59,000 9 (7%) 5 (8%) 4 (6%)
$60,000–$69,000 11 (8%) 5 (8%) 6 (9%)
$70,000 37 (28%) 11 (17%) 26 (37%)

Employment Full time 60 (45%) 26 (41%) 34 (49%)
Part time 12 (9%) 6 (9%) 6 (9%)
Unemployed 9 (7%) 5 (8%) 4 (6%)
Homemaker 4 (3%) 2 (3%) 2 (3%)
In school 1 (1%) 0 (0%) 1 (1%)
Retired 35 (26%) 17 (27%) 18 (26%)
Other 13 (10%) 8 (12%) 5 (7%)

NCM, nurse case management; SC, standard care.
Note: No significant differences between randomized groups; all p values >0.05.

Figure 2. Changes in A1C levels and DDS scores in 6 months in the NCM and SC groups.
Sample means with 95% CIs for each treatment group at baseline and after 6 months
are shown. A1C, HbA1c; DDS, diabetes distress score; NCM, nurse case manage-
ment; SC, standard care.

D. Li et al. / Can J Diabetes 41 (2017) 297–304 301

Behavioural outcomes
NCM participants consumed more fruit and vegetables (an

increase of 1 day of eating more than 4 servings of fruit and veg-
etables in a week; p<0.01); exercised more (an increase of 1 day of more than 30 minutes of exercise in a week; p<0.01) and checked their feet more often (an additional increase of 1 day per week for feet checks; p=0.049) compared to the SC group at the 6-month follow up. Both groups were similar in number of blood sugar checks in a week (4 to 5 checks per week) and medication compliance (score of 1 on the 4-item Morisky scale, which indicated good medica- tion compliance), at the baseline and at the 6-month follow up.

Psychosocial outcomes
At baseline, both groups had mild depression, based on the PHQ-9

scores. At the 6-month follow up, NCM participants had fewer

depressive symptoms (an additional reduction of 3 points; p<0.01), with average score indicating minimal depression. There was no change in the SC group. NCM participants also reported a greater amount of support received and were more motivated. Although both groups, at baseline, had mean Patient Activation Measure scores that fell into the stage 3 category (stage 3 indicates taking actions for diabetes self-care in normal circumstances), NCM participants were able to move to stage 4 (p<0.01), which indicates ability for self-care in circumstances of physical illness or mental distress.

Other observations

During the course of the study, 9 patients in the NCM group and
11 patients in SC group were hospitalized. There were no hospi-
talizations for hypoglycemia or acute hyperglycemia in either group.

Table 2
Primary and secondary outcomes: changes from baseline

All
N=134
SC
n=64
NCM
n=70

Difference in changes between
groups, adjusted for baseline
(95% CI)

p value

Primary outcomes
Change in A1C −2.41 −2.06 −2.72 −0.731 0.027

(2.57) (2.58) (2.54) (−1.377, −0.085)
q=4 q=3 q=1

Change in DDS −0.35 −0.15 −0.54 −0.403 0.001
(0.83) (0.92) (0.68) (−0.629, −0.176)
q=14 q=6 q=8

Secondary outcomes
Clinical outcome measures BMI 0.05 −0.20 0.28 0.564 0.190

(2.53) (3.15) (1.78) (−0.283, 1.411)
q=17 q=8 q=9

SBP −3.58 −0.12 −6.71 −8.059 0.021
(21.24) (20.03) (21.96) (−14.861, −1.257)
q=16 q=8 q=8

DBP −3.50 −0.64 −6.08 −4.911 0.014
(13.00) (13.92) (11.62) (−8.803, −1.020)
q=16 q=8 q=8

Behavioural outcome measures Fruit and vegetable intake 0.39 −0.26 1.02 1.112 0.010
(2.95) (2.92) (2.86) (0.274, 1.950)
q=15 q=6 q=9

Fat intake 0.08 0.07 0.08 −0.761 0.056
(2.45) (2.94) (1.9) (−1.541, 0.019)
q=15 q=6 q=9

Physical activity 0.4 −0.17 0.94 1.277 0.007
(3.23) (2.83) (3.5) (0.359, 2.195)
q=14 q=6 q=8

Specific exercise 0.26 −0.29 0.77 1.319 0.005
(3.12) (2.97) (3.19) (0.418, 2.220)
q=14 q=6 q=8

Foot exam 1.34 0.62 2.02 1.006 0.049
(3.56) (3.44) (3.56) (0.004, 2.008)
q=14 q=6 q=8

Blood glucose monitoring 0.88 0.90 0.85 −0.259 0.528
(2.94) (3.12) (2.79) (−1.069, 0.551)
q=14 q=6 q=8

Medication adherence 0.01 0.05 −0.03 −0.130 0.441
(1.17) (1.33) (1.01) (−0.464, 0.203)
q=15 Q=7 Q=8

Psychosocial outcome
measures

Patient activation measure 3.16 1.16 5.03 6.364 <0.001 (10.86) (11.37) (10.09) (3.335, 9.393) q=14 q=6 q=8

PHQ-9 −0.41 1.09 −1.82 −2.954 <0.001 (4.67) (4.42) (4.48) (−4.381, −1.527) q=14 q=6 q=8

Amount of support 0.32 −0.05 0.68 0.504 0.004
(1.29) (1.30) (1.18) (0.169, 0.838)
q=14 q=6 q=8

Satisfaction with support 0.21 0.00 0.4 0.297 0.075
(1.18) (1.25) (1.09) (−0.030, 0.625)
q=15 q=7 q=8

A1C, glycated hemoglobin; BMI, body mass index; DBP, diastolic blood pressure; DDS, Diabetes Distress Scale; PHQ-9, 9-item Patient Health Questionnaire; SBP, systolic blood
pressure.
Note: Data are mean (SD); q = number of missing observations. Differences between groups are adjusted for baseline, and the associated p values are calculated using linear
regression.

D. Li et al. / Can J Diabetes 41 (2017) 297–304302

Discussion

This is the first RCT of a NCM intervention involving patients with
type 2 diabetes in a Canadian tertiary care setting that demon-
strated that NCM was effective in improving glycemic control and
reducing diabetes distress. Furthermore, this intervention also led
to improvements in other clinical, behavioural and psychosocial
outcomes.

Given that our sample was drawn from a tertiary care setting,
participants were more likely to have poorer glycemic control and
were at higher risk than the general population of persons with
type 2 diabetes. Therefore, it is not surprising this group would be
more receptive and amenable to an NCM intervention (12,24).

This was a behavioural-intervention study, so it is difficult to
delineate which component of the intervention worked best. It is
interesting that medication compliance and glucose testing did not
change over the course of the study for either the intervention or
the control group. These findings suggest that improvements in life-
style behaviours, such as dietary patterns and physical activity, may
have been the mechanism of change. Alternatively, frequent medi-
cation adjustment may also account for A1C level and blood pres-
sure reductions in the intervention group; however, that variable
was not measured in this study.

The rate of diabetes distress is high in patients with type 2 dia-
betes. Previous research has found NCM interventions to improve
psychosocial outcomes, such as depression (25), but only 1 has
reported a reduction in diabetes distress (26). This the first study
of NCM presence conducted in a Canada-based specialty care setting
to demonstrate reduction in diabetes distress and also improve-
ments in depressive symptoms, patient motivation and perceived
social support.

Diabetes distress is associated with worse glycemic control (27).
In fact, Pandit et al (28) found that, compared to minimally dis-
tressed patients, highly distressed patients had higher levels of A1C,
diastolic BP and LDL cholesterol. Diabetes self-management edu-
cation has been shown to decrease diabetes distress, such that a
reduction of 10 points on the Problem Areas in Diabetes (PAID) scale
was associated with a clinically significant reduction in A1C levels
of 0.55% (29). It is possible that improvements in distress and depres-
sion also contributed to A1C-level reductions. Future studies using
structural equation modelling should be conducted to examine this
question.

Limitations to this study need to be acknowledged. The study
budget relied upon blood laboratory analysis being reimbursed by
the BC Ministry of Health; all blood draws were subject to province-
specific guidelines. These guidelines support 3 monthly A1C tests,
but a lipid panel is recommended only annually. Consequently, not
all physicians ordered lipid panels at both baseline and 6 months
and, indeed, some were resistant to this level of testing. Given this
inconsistency, we could not include lipid profiles or any other clini-
cal outcomes that are measured only annually. Finally, we did not
build a formal cost analysis into the study; therefore, we are not
able to provide any cost-effectiveness data. However, such an NCM
model has already been adopted nationwide in a primary care setting
in Germany and has proven to improve survival time, lower mean
daily hospital and mean daily drug costs (30).

Conclusions

Nurse case management was an effective model for improving
A1C levels and reducing diabetes distress in a tertiary care setting.
Therefore, it is a viable adjunct to standard care, particularly for the
inadequately controlled patients with type 2 diabetes who are
referred for specialist care.

Acknowledgements

The authors acknowledge the contributions made by the patients,
the physicians, the nurse case manager and the office staff, in addi-
tion to the staff at the collaborating hospitals, who have made this
work possible and specially acknowledge Harlan Campbell and Darby
Thompson for their help with statistical analysis.

Author Disclosures

This study was supported by the British Columbia Endocrine
Research Foundation (itself supported by a grant from Sanofi-
Aventis Canada). Clinical trial registry #NCT01659294,
clinicaltrials.gov. Dr. Tom Elliott has received funding for giving lec-
tures and symposia and attending advisory boards for the follow-
ing companies: Sanofi, NovoNordisk, Boehringer-Ingelheim and
Astra-Zeneca. Dr. Ehud Ur has received funding for giving lectures
and symposia and attending advisory boards for the following com-
panies: Sanofi, NovoNordisk, Boehringer-Ingelheim, Merck and
Astra-Zeneca.

Author Contributions

TT, TE and EU were the principal investigators; DL, TT TE and
EU contributed to study’s conception and design, data analysis and
interpretation; GK was the study coordinator and collected data for
analysis; DL and TE prepared the manuscript for submission, and
TT, GK and EU reviewed and edited the manuscript prior to its
submission.

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Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial

Introduction
Methods
Study design, setting and population
Inclusion/exclusion criteria
Recruitment
Randomization process
Nurse case manager intervention
Diabetes education
Monitoring and algorithm-driven treatment adjustment
Linkage to allied healthcare services
Standard care
Participation and assessment
Outcomes and measurements
Demographic characteristics
Sample size and power
Statistical analysis
Results
Study sample
Participants’ characteristics
Primary outcomes
Glycemic control
Diabetes distress
Secondary outcomes
Clinical outcomes
Behavioural outcomes
Psychosocial outcomes
Other observations
Discussion
Conclusions
Acknowledgements
Author Disclosures
Author Contributions
References

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