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


Show simple item record Petersen, Inge Bhana, Arvin Folb, Naomi Thornicroft, Graham Zani, Babalwa Selohilwe, One Petrus, Ruwayda Mntambo, Ntokozo Georgeu-Pepper, Daniella Kathree, Tasneem Lund, Crick Lombard, Carl Bachmann, Max Gaziano, Thomas Levitt, Naomi Fairall, Lara 2018-05-04T10:12:47Z 2018-05-04T10:12:47Z 2018-03-22
dc.identifier.citation Trials. 2018 Mar 22;19(1):192
dc.description.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 ( ) (DOH-27-0916-5051). Registered on 9 April 2015. : ID: NCT02425124 . Registered on 22 April 2015.
dc.language.iso en
dc.publisher BioMed Central
dc.source Trials
dc.subject.other Hypertension
dc.subject.other Depression
dc.subject.other Primary health care
dc.subject.other Low- and middle-income countries
dc.subject.other Integrated health care
dc.title 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
dc.type Journal Article 2018-04-09T15:13:18Z
dc.rights.holder The Author(s).
dc.publisher.institution University of Cape Town
dc.publisher.faculty Faculty of Health Sciences en_ZA
dc.publisher.department Department of Public Health and Family Medicine en_ZA
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