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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Hypertension
• Intervention / Treatment: Behavioral: PC101+Mental Health

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.

• Study Type: Interventional
• Enrollment (Actual): 1052
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • North West Province
    • Dr Kenneth Kaunda District, North West Province, South Africa, 2577
      • Primary Health Care Facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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: 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.	Behavioral: 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.

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

Collaborators and Investigators

• Sponsor: University of KwaZulu
• Collaborators: King's College London; Department for International Development, United Kingdom; University of Cape Town
• Investigators: Principal Investigator: Graham Thornicroft, PhD, King's College London; Principal Investigator: Inge Petersen, PhD, University of KwaZulu; Principal Investigator: Lara R Fairall, PhD, University of Cape Town

Publications and helpful links

General Publications

• Petersen I, Fairall L, Zani B, Bhana A, Lombard C, Folb N, Selohilwe O, Georgeu-Pepper D, Petrus R, Mntambo N, Kathree T, Bachmann M, Levitt N, Thornicroft G, Lund C. Effectiveness of a task-sharing collaborative care model for identification and management of depressive symptoms in patients with hypertension attending public sector primary care clinics in South Africa: pragmatic parallel cluster randomised controlled trial. J Affect Disord. 2021 Mar 1;282:112-121. doi: 10.1016/j.jad.2020.12.123. Epub 2020 Dec 28. Erratum In: J Affect Disord. 2021 May 1;286:370.
• Petersen I, Bhana A, Folb N, Thornicroft G, Zani B, Selohilwe O, Petrus R, Mntambo N, Georgeu-Pepper D, Kathree T, Lund C, Lombard C, Bachmann M, Gaziano T, Levitt N, Fairall L; PRIME-SA research team. Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial. Trials. 2018 Mar 22;19(1):192. doi: 10.1186/s13063-018-2518-6.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2015
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HRPC10