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Trials. 2018 Mar 22;19(1):192. doi: 10.1186/s13063-018-2518-6.

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.

Author information

1
Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa. peterseni@ukzn.ac.za.
2
Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu- Natal, Durban, South Africa.
3
Health Systems Research Unit, South African Medical Research Council, Durban, South Africa.
4
Knowledge Translation Unit, University of Cape Town, Cape Town, South Africa.
5
Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, Kings College, London, UK.
6
Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
7
Biostatistics Unit, South African Medical Research Council, Cape Town, South Africa.
8
School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
9
Department of Population Health and Primary Care, Norwich Medical School, University of East Anglia, Norwich, UK.
10
Department of Health Policy and Management, Harvard University, Cambridge, USA.
11
Department of Diabetic Medicine and Endocrinology, University of Cape Town, Cape Town, South Africa.

Abstract

BACKGROUND:

The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).

METHODS/DESIGN:

The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.

DISCUSSION:

This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.

TRIAL REGISTRATION:

South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.

KEYWORDS:

Depression; Hypertension; Integrated health care; Low- and middle-income countries; Primary health care

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