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NCT number NCT03497390
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date March 2018

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 1-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 2-year. The primary outcome will be glycemic control as measured by HbA1c compared to baseline. Secondary outcomes include control of blood pressure, low-density lipoprotein cholesterol, body mass index and other obesity indices compared to baseline.Tertiary outcomes include hospital admissions, hypoglycaemic episodes, psychobehavioural parameters as measured by questionnaires and all clinical endpoints such as incident cardiovascular-renal events and mortality. A per-protocol analysis will be performed to assess the correlations between adherence to these activities and improvement in metabolic control.


Clinical Trial Description

Aim: To evaluate a novel individualized, multicomponent care program to optimize metabolic control in obese type 2 diabetic participants with suboptimal 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.

Settings: The participants would be identified from the Prince of Wales Hospital (PWH). The recruitment period would be 6 months. 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, 12-20 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, these patients return 8-12 weeks later to undergo a 2-hour group session where nurses will explain the JADE report and reinforce patients about their treatment targets and self-blood glucose monitoring techniques. Since these patients usually undergo comprehensive assessment, receive education and attend medical clinic visits in the same group, these settings have provided an excellent opportunity for healthcare providers to create an environment and use group dynamics to promote collaborative learning as well as provide mutual social and emotional support.

For this EMERALD (E) project, 410 eligible participants will be randomized to either the E or usual care (UC) group, which was 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.

Participants assigned to the UC group will be followed up in their usual clinic according to the 'standard' practice. Participants assigned to the E group will be invited to join the 1-year multi-component program. They will have the nature of the program and the follow-up schedule explained to them. This multi-component program will be held on a 4-weekly basis for the first 3-4 months followed by a maintenance program involving 2-4 group activities every year. Between clinic visits, participants in E group will also receive telephone reminders from the staff and peer supporters for reinforcement of compliance and for social support. Participants who refuse to join will be asked about the reasons for refusal and this will be documented for future analysis.

Intervention procedure for EMERALD Group Participants assigned to the E group will be followed up at the PWH Diabetes Centre led by the nurses and supported by diabetologists. All medical follow up visits will take place in the Diabetes Centre instead of the busy medical clinics. All participants will be followed up by diabetes specialists or trained doctors using the HbA1c and age, body weight, presence of diabetes complications, and disease duration of diabetes (ABCD) algorithm proposed by a group of experts with particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm.

Overall framework Participants assigned to the E group will undergo an intensive 3-4 months empowerment program where participants within the same group sharing similar profiles will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. The doctors will adjust medical therapy on a 3-4 monthly basis with the nurses reinforcing compliance and providing the liaison between the doctor and patient. Between medical visits, the nurses or research assistant will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule. All participants will be encouraged to exchange telephone numbers and the peer supporters are encouraged to organize ad lib activities depending on the group dynamics. At each group visits (including the 3-4 monthly medical visit), all participants will measure their own blood pressure (BP) and body weight and list HbA1c value (available every 3 months) for sharing. Participants with the best (or improved) results and those with the least optimal (or deteriorated) results will be encouraged to share their experiences. The nurse will serve as a facilitator, assisted by the peer supporters, to encourage group sharing and problem-shooting. In the 9-month maintenance period, the nurses and peer supporters will organize at least 2 group activities open to all patients in the E group. Attendance for these group activities will be documented for future per protocol analysis. After 1 year, participants will return to their usual care management.

Medical review and social activities open to all groups. Endocrinologists will use ABCD algorithm to titrate treatment in the E group who will also be given JADE follow-up reports to engage them in the care and management process by informing participants the trends of risk factor control (HbA1c, BP, low-density lipoprotein cholesterol [LDL-cholesterol] and body weight) and used of medications. All participants will undergo repeat assessments at 1 year and 2 years using the standard protocols.

Clinical and laboratory parameters will be measured in the diabetes complications screening as described in the Hong Kong Diabetes Registry and JADE (2) with detailed documentation of HbA1c, BP, LDL-cholesterol, body mass index (BMI), waist circumference (WC) and other parameters. Participants in the UC will be followed up in their usual clinic managed by their usual care providers. The outcome measures including HbA1c, BP, LDL cholesterol, admissions, hypoglycaemic episodes and all clinical endpoints will be captured by the Hospital Authority (HA) Computer Management System (CMS). In addition, repeat diabetes complication screening will be provided to all participants in the E and UC group at 1 year and 2 years for comparison. Psychological parameters will be measured by questionnaires including Patient Health Questionnaire 9 (PHQ9), EuroQoL-5D (EQ-5D), Summary of Diabetes Self-Care Activities-16 (SDSCA-16), Depression Anxiety-Stress Scale (DASS-17) and Dissociative Experiences Scale-11 (DES-11).

Statistical Analysis: Data will be double-entered for validation and presented using appropriate descriptive statistics. Skewed variables will be transformed. Between-group comparisons of baseline values will be made using t-test, Mann-Whitney test, Pearson Chi-square or Fisher's exact test, as appropriate. Mixed-effects modes will be used to compare the differential changes on various outcome variables across the time points at T1 (baseline), T2 (year 1) and T3 (year 2) between the two study arms with adjustment for potential confounders. The potential confounders will be selected on the basis of clinical judgement and statistical incomparability at the baseline. Baseline clinical characteristics with p values <0.25 for between-group difference and other variables that may confound the comparison results of the outcomes based on the clinical judgement will be considered as potential confounders. Mixed-effects model can account for intra-correlated repeated measures data and accommodate missing data caused by incomplete visits or those who have dropped-out, provided the data are missing at random. Mixed-effects models will be performed using the PROC MIXED (SAS Institute, Cary, NC, release 9.2). Other statistical analyses will be done using Statistical Package for the Social Science (SPSS) 18.0. A two-sided P<0.05 is considered significant.

Sample size determination: The sample size estimation of the study is based on the primary outcome, i.e. changes in HbA1c at 0 and 2 years between the two study arms. The investigators used the method of Hedeker et al that can handle sample size estimation for longitudinal study with attrition and its associated program RMASS2 to estimate the sample size. In this study, the investigators aim to detect a mean difference of within-subject change in HbA1c between the two arms of value of at least 0.5%. Based on previous study, the investigators expect a standard deviation of 1.7% for HbA1c in the targeted population. From the investigators' experience on follow-up studies on diabetic patients, the attrition rate should be less than 20%. Using the freeware RMASS2, the investigators estimate that 205 subjects per study arm will assure the study 80% power at 5% level of significance to detect a mean difference of 0.5% in HbA1c between the two groups at year 1 and 2, assuming no between-group differences in baseline HbA1c, a standard deviation of HbA1c of 1.7%, and an attrition rate of 20%.


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