Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,052
- 试验地点
- 2
- 主要终点
- Depression
研究概览
简要总结
A pragmatic cluster randomized controlled trial (RCT) in 20 public sector primary care clinics in the Dr Kenneth Kaunda district of the North West Province of South Africa to assess mental health and health outcomes for depressed adults receiving hypertensive treatment by measuring the real-world effectiveness of a facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression. The control condition is enhanced usual primary health care where non-physician clinicians have been equipped with the basic skills to identify stress and depression/anxiety but with limited access to doctors authorized to prescribe antidepressant medication, and with no specific psychosocial interventions.
详细描述
Cardiovascular disease (hypertension and stroke) is the leading cause of mortality in the world and the second leading cause of death in Africa. Estimates by the WHO using disability adjusted life years (DALYs) suggest that NCDs were responsible for 28% of the total burden of disease in South Africa in 2004, with heart disease, diabetes and stroke together being responsible for the second most important cause of death in adult South Africans. In the investigators 2014 survey of 3 primary health care facilities in the North West Province where the Department of Health is piloting Integrated Chronic Disease Management the investigators found that of the 1 250 chronic care patients surveyed, 51% reported having hypertension. Spurring the rising burden of NCDs are mental disorders. One in 6 adults experience a common mental disorder (depression, anxiety disorders and substance use disorders) within a 12 month period (Herman et al., 2009), one in four receive treatment of any kind (Seedat et al., 2009). Depression co-exists with NCDs having a mutually reinforcing relationship compromising both prevention and treatment through exacerbating modifiable risk factors and compromising adherence and self-care respectively. Objectives: The investigators propose to strengthen the Primary Care 101 guidelines. This is a set of clinical guidelines and decision support for nurses developed for the identification and management of multiple chronic diseases.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty (20) largest clinics providing chronic care Patients
- •Receiving hypertensive treatment at time of enrolment
- •Depressive symptoms as indicated by total score of 9 or more on PHQ-9
- •Planning to reside in area for the next year
- •Capable of actively engaging in interviewer-administered questionnaire at time of recruitment, 6 months and 12 months later
- •Written consent to participate in the study
排除标准
- •Clinics that do not provide Integrated Chronic Disease Management
- •Small (<10 000 attendances/ year)
- •Mobile or satellite
- •Participated in piloting of intervention & data collection. Patients
- •Inability to meet the above inclusion criteria
研究组 & 干预措施
Control
PC101 Enhanced usual primary health care where non-physician clinicians have been equipped with the basic skills to identify stress and depression/anxiety but with limited access to doctors authorized to prescribe antidepressant medication, and with no specific psychosocial interventions.
干预措施: PC101+Mental Health (Behavioral)
Intervention
PC101 + Mental Health Facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression.
干预措施: PC101+Mental Health (Behavioral)
结局指标
主要结局
Depression
时间窗: 6 Months
50 % reduction in PHQ-9 score
次要结局
- Antidepressant treatment(12 months)
- Blood pressure(6 months and 12 months)
- Counselling(12 months)
- Disability(12 Months)
- Productivity and economic outcomes(12 months)
- Stress(12 Months)
- Referral to specialist mental health worker/service(12 months)
- Diagnosis of other comorbid illnesses(12 months)
- All cause mortality(12 months)
- Depression(6 months; 12 months)
- Retention in care(12 months)
- Cardiovascular risk factors(12 months)
- Healthcare utilization(12 months)
- Quality of chronic illness care received(12 months)
研究者
Inge Petersen
Professor
University of KwaZulu