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All-encompassing Program Led by Diabetes Specialist Team

NCT03497390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Health Care Delivery

Interventions

OTHER

EMERALD intervention

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.

OTHER

Usual care

Usual care without any workshop or program

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Alice Kong, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497390 on ClinicalTrials.gov