Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
1 other identifier
interventional
1,052
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Apr 2015
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedStudy Start
First participant enrolled
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedApril 17, 2019
April 1, 2019
1.5 years
April 10, 2015
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Depression
50 % reduction in PHQ-9 score
6 Months
Secondary Outcomes (16)
Depression
12 months
Depression
12 months
Depression
6 months; 12 months
Blood pressure
6 months and 12 months
Disability
12 Months
- +11 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORPC101 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.
Intervention
EXPERIMENTALPC101 + 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of KwaZululead
- Department for International Development, United Kingdomcollaborator
- University of Cape Towncollaborator
- King's College Londoncollaborator
Study Sites (1)
Primary Health Care Facilities
Dr Kenneth Kaunda District, North West, 2577, South Africa
Related Publications (2)
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.
PMID: 33412490DERIVEDPetersen 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.
PMID: 29566730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inge Petersen, PhD
University of KwaZulu
- PRINCIPAL INVESTIGATOR
Lara R Fairall, PhD
University of Cape Town
- PRINCIPAL INVESTIGATOR
Graham Thornicroft, PhD
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 23, 2015
Study Start
April 22, 2015
Primary Completion
October 31, 2016
Study Completion
July 31, 2017
Last Updated
April 17, 2019
Record last verified: 2019-04