Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03497390 |
| Other study ID # |
EMERALD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2012 |
| Est. completion date |
February 2017 |
Study information
| Verified date |
March 2022 |
| Source |
Chinese University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Obese type 2 diabetic patients are difficult to treat with many unmet needs requiring complex
treatment regimens, intensive counselling and emotional support. Traditional anti-diabetic
drugs, such as sulphonylureas and insulin, are known to have side-effects of weight gain and
can offset the benefits of glycemic control and increase cardiovascular risks. Aside from
these therapeutic challenges, psychological needs of these obese diabetic patients due to
anxiety, stigmatization, stress, depression cannot be adequately addressed in a busy clinic
setting. Here, the investigators propose to conduct this translational study aiming to
compare the effects of a multi-component care program with personalized drug regimen
augmented by behavioural therapy with psychological support and peer influence, led by a
diabetes specialist team on metabolic control and psychobehavioural parameters in obese type
2 diabetic participants with poor glycemic control (glycated hemoglobin [HbA1c]>8%) versus
usual care. The 1-year multi-component program will be followed by a 2-year observational
period in the EMERALD group. Outcome measures will be assessed in all participants in the
EMERALD and usual care group at 1-year and 3-year. The primary outcome was between-group
differences in HbA1c from baseline to year 1 and year 3. The secondary outcomes were the
proportion of patients who attained key performance indexes (KPIs; defined by reduction [Δ]
in HbA1c≥0.5%, ΔSBP≥5 mmHg, ΔLDL-cholesterol≥0.5 mmol/L and Δbody weight≥3%) and BMI<25
kg/m2. systolic/diastolic BP, lipid levels (total cholesterol, LDL-cholesterol, triglyceride,
high-density lipoprotein cholesterol [HDL-cholesterol]), obesity indices (body weight, BMI
and waist circumference) and patient-reported outcomes. The latter included self-care and
treatment adherence (assessed by 16-item Summary for Diabetes Self-Care Activities
[SDSCA-16]), empowerment (assessed by Chinese Diabetes Empowerment Scale-10 [CDES-10]),
quality of life (assessed by 5-item EuroQoL [EQ-5D]) and depression/anxiety (assessed by
9-item Patient Health Questionnaire [PHQ-9]) and 21-item Depression Anxiety Stress Scale
[DASS-21]). A per-protocol analysis will be performed to assess the correlations between
adherence to these activities and improvement in metabolic control.
Description:
Aim: To examine the effects of 1-year team-based multi-component intervention care (MIC)
program in obese T2D with poor glycemic control
Hypothesis: The change from a traditional clinic consultation to an individualized,
multicomponent care program will improve cardiometabolic parameters in suboptimally treated
obese type 2 diabetic participants.
Study design: This is a pilot translational study aiming to compare the effects of a
multi-component care program with personalized drug regimen augmented by behavioural therapy
with psychological support and peer influence, led by a diabetes specialist team on metabolic
and psychobehavioural health in obese type 2 diabetic participants versus usual care (UC).
Settings: The participants would be identified from the Prince of Wales Hospital (PWH). The
recruitment period would be 2 years. Since 1995, the PWH runs a comprehensive complication
screening program in the ambulatory Diabetes Centre. On a weekly basis, 50-100 patients
undergo assessments for risk factors and complications by nurses and healthcare assistants
using standard protocols. On average, 8-12 patients attend each session. Since 2007, these
data are entered into a web-based Joint Asia Diabetes Evaluation (JADE) Program which
incorporates a validated risk engine to generate an integrated report with risk categories,
care protocols, trends of risk factor control and decision support to empower both doctors
and patients to make informed decisions. After the assessments, During the first two months
of intervention, each group would have three 3.5-hour face-to-face workshops with the nurses
(week 0, 4 and 8). This would be reduced to 2-hour per workshop 4-monthly thereafter in the
following ten months (week 24, 40, 56) i.e. a total of six sessions per group in 1-year
intervention. At each workshop, the nurses would use role plays, quizzes, reflective stories
and on-site fitness classes to instill these key principles. Each workshop would use similar
strategies including goal-setting, health behaviors tracking and peer sharing on personal
progress. During this 1-year MIC program, 4 out of 6 workshops would be conducted when
participants would be waiting to see endocrinologists (at week 24, 40 and 56). The
consultations would be around 15-minute for each participant per visit. In the first two
months of intervention, each MIC group also would receive three 20-minute telephone reminders
from HCA at 4-weekly intervals (week 0, 4, 8). The call frequency would be reduced to
4-monthly intervals in the following ten months (week 24, 40, 56) i.e. a total of six calls
per group. Group members would also be acted as peer supporters for one another in groups of
3 to 4 patients with at least one telephone reminder between workshops. The calls would be
guided by structured log sheets focusing on adherence to lifestyle modification, medications
and action plan, as well as to identify patients who would require ad-hoc support from the
nurses.
The MIC group would return to UC after exit from the 1-year intervention. During the ensuing
two years, the MIC group would receive mailing of three simplified JADE follow-up reports at
month 18, month 24 and month 30 where the HCA entered BP, HbA1c, body weight and
LDL-cholesterol retrieved from the clinic notes or laboratory measurements to provide
feedback to the patients. They would be invited to an annual 4-hour group gathering where
doctors and nurses would invite patients who achieve and/or maintain risk factor control to
share their success stories and provide motivational support to the group.
The UC group would have traditional clinic-based consultation at 3 to 4-monthly intervals in
either general medical or diabetes clinic. They would have consultation by different doctors
who might or might not refer them to dietitians or nurses for education. There would be no
workshops or peer supporters in the UC group.
For this EMERALD project, eligible participants will be randomized to either the MIC or UC
group, which will be done independently by a statistician. The group allocation of each
participant will be assigned by having a staff independent of the study. Computer generated
random codes will be prepared by the statistician prior to participant recruitment and the
codes will be stored in a computer. Irrespective of the assignment group, all participants
will receive a 2-hour session on how to interpret the JADE report and their risk profiles and
will be reinforced on the importance of achieving targets and optimizing self-care.
Statistical Analysis: Descriptive data would be presented as mean ± standard deviation (SD),
median (interquartile range) or number (percentage), as appropriate. Triglyceride and urinary
albumin-to-creatinine ratio (ACR) would be logarithmically-transformed due to skewed
distribution. We would compare baseline characteristics between two groups using either
independent t or Wilcoxon rank-sum test for continuous variables, and either χ2 or Fisher's
exact test for categorical variables. For continuous and binary outcomes obtained over time,
we would perform generalized estimating equations (GEE) analysis in all patients who would
have baseline and at least one follow-up measurement. Using UC as referent, we would
introduce a group × time (baseline, year 1 and year 3) interaction term in the GEE models to
examine the between-group differences from baseline to year 1 and year 3, adjusting for sex
and time-varying covariates namely age, disease duration, BMI, use of insulin, oral glucose-,
BP- and lipid-lowering agents. When either body weight or waist circumference would be the
dependent variable, BMI would be excluded from the model due to collinearity (Pearson
correlation 0.84-0.86). The between-group difference for each continuous or binary outcome
would be expressed in mean or adjusted odds ratio (aOR) with 95% confidence interval (CI),
respectively. GEE analysis can account for correlations between repeated measurements for any
individual patient and accommodate missing data caused by dropout, provided these data are
missing at random.
Because HbA1c<7% and KPIs would be null values at baseline in both groups, we would run
separate multiple logistic regression analysis that incorporate these data at year 1 and year
3, with group allocation as an independent variable, adjusting for the aforementioned
covariates. Data would be analysed using SPSS version 24.0 (Chicago, IL). A two-tailed
P-value<0.05 would be considered significant.
Sample size determination: In this quasi-experimental real-world experiment with comparative
group, we estimate that 100 patients in each group would give 80% power at α=0.05 to yield a
0.5% difference at one year, with comparable baseline HbA1c levels and a standard deviation
(SD) of 1.2% and 10% attrition rate.
