Improving Mental Health Through Integration With Primary Care in RuralKarnataka.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,687
- 试验地点
- 1
- 主要终点
- anxiety or depression
研究概览
简要总结
This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model compared to enhanced standard care treatment. The primary outcome measures include
- Incidence of dually diagnosed participants
incidence of patients presenting to Primary Health Clinic (PHC) with a dual diagnosis of depression or anxiety, and
diabetes or cardiovascular disease in in the standard versus enhanced screening arms.
- anxiety or depression
levels of anxiety or depression reported by participants, depending on initial diagnosis
- blood glucose control
for patients presenting with diabetes
- blood pressure
for patients presenting with hypertension
- cholesterol
for patients presenting with hypercholesterolemia
Secondary Outcome Measures:
- medication adherence
adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •30 years or older; • Diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either • Able and willing to consent and participate in the intervention and all assessments; • Able to speak Kannada; and • Mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score greater than 26).
排除标准
- •Under 30 years of age; • Patients who are not diagnosed with co-morbid CMD (Depression or Anxiety Disorder) and either hypertension, diabetes, or diagnosed ischemic heart disease; • Not mentally competent to provide consent and answer to study measures and participate in intervention (MMSE score > 26).
- •â€¢ Unable to speak Kannada; and • Participants who do not provide contact information.
结局指标
主要结局
anxiety or depression
时间窗: 1 year
Blood glucose control
时间窗: 1 year
blood pressure and cholesterol for patients presenting with diabetes hypertension hypercholesterolemia
时间窗: 1 year
Incidence of dually diagnosed participants
时间窗: 1 year
次要结局
- medication adherence adherence to medical regimen using a Visual Analog scale. Specific regimen depends on initial diagnosis [Time Frame: 1 year(1 YEAR)