INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 4
- 主要终点
- Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
研究概览
简要总结
To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at four diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.
详细描述
It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥35 years
- •Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
- •PHQ-9 score≥10
- •≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used
- •Willingness to consent to randomization.
排除标准
- •The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral
- •Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
- •Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)
- •Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
- •Pregnancy or breastfeeding
- •Documented CVD event (MI, stroke) in past 12 months
- •End-stage renal disease awaiting transplant
- •Malignancy or life-threatening disease with death probable in 3 years
- •Alcohol or drug abuse
- •No fixed address or contact details.
结局指标
主要结局
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
时间窗: 24-months post-intervention
The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).
次要结局
- Mean Changes in Each of the Four Main Targets: HbA1c(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Mean Changes in Each of the Four Main Targets: SBP(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Mean Treatment Satisfaction Scores(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Mean Health Expenditures (Direct Medical Costs)(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Cost Utility in the Treatment Arm and Usual Care Arms(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Measures of "Common Effect"(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
- Mean Changes in Each of the Four Main Targets: SCL-20 Score(12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up))
研究者
Mohammed K Ali, MD, MSc, MBA
Associate Professor
Emory University