Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial

Conditions
-----------------
Depression, Hypertension

Intervention / Treatment
-----------------
* Behavioral: PC101+Mental Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinics 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 Exclusion Criteria: Clinics 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Behavioral: PC101+Mental Health<br>* 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.<br>|
| Experimental: Intervention<br>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. | Behavioral: PC101+Mental Health<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 50 % reduction in PHQ-9 score | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 50 % reduction in the PHQ-9 score | 12 months | 
| Depression | Remission defined as score of <5 on PHQ9 | 12 months | 
| Depression | Mean PHQ9 scores | 6 months; 12 months | 
| Blood pressure | Difference in means | 6 months and 12 months | 
| Disability | Mean score using the Manual for WHO Disability Schedule WHODAS 2.0 schedule | 12 Months | 
| Stress | Mean score using Perceived Stress Scale | 12 Months | 
| Antidepressant treatment | Proportion with antidepressant treatment initiated or intensified | 12 months | 
| Counselling | Proportion receiving counselling by clinic-based counsellor | 12 months | 
| Referral to specialist mental health worker/service | Proportion referred | 12 months | 
| Retention in care | Proportion in care | 12 months | 
| Cardiovascular risk factors | Difference in means | 12 months | 
| Diagnosis of other comorbid illnesses | Proportion diagnosed | 12 months | 
| Quality of chronic illness care received | Mean Patient Assessment of Care for Chronic Conditions (PACIC) score | 12 months | 
| Healthcare utilization | Incidence rate ratio using linkage with hospitalisation databases | 12 months | 
| Productivity and economic outcomes | Productivity and economic outcomes | 12 months | 
| All cause mortality | Proportion died | 12 months |