Overview

This trial is active, not recruiting.

Conditions depression, hypertension
Treatment pc101+mental health
Sponsor University of KwaZulu
Collaborator Department for International Development, United Kingdom
Start date April 2015
End date November 2016
Trial size 1052 participants
Trial identifier NCT02425124, HRPC10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Active Comparator)
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.
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.
(Experimental)
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.
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.

Primary Outcomes

Measure
Reduced depressive symptoms assessed by using the Patient Health Questionnaire 9 (PHQ-9)
time frame: 6 Months

Secondary Outcomes

Measure
Blood pressure control as measured by chart extraction of blood pressure readings
time frame: 12 Months
Adherence to medication adherence assessed using the self-reported Visual Analogue Scale
time frame: 12 Months
Perceived stress symptoms assessed using the Perceived Stress Scale
time frame: Baseline; 12 Months
Disability measured using the Manual for WHO Disability Schedule WHODAS 2 .0
time frame: Baseline; 12 Months
Response at 12 months assessed by using the Patient Health Questionnaire 9
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
Principal investigator Inge Petersen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of KwaZulu.