All-encompassing Program Led by Diabetes Specialist Team
Condition: Health Care Delivery
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): EMERALD intervention; Usual care
Intervention type(s): Other; Other
Intervention description(s): EMERALD consists of a 1-year multi-component structured program led by nurses and held 4-weekly for the first 3 months, followed by maintenance program, peers support and telephone calls.; Usual care without any workshop or program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Type 2 diabetes; Obesity