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

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dc.contributor.authorPetersen, Inge
dc.contributor.authorBhana, Arvin
dc.contributor.authorFolb, Naomi
dc.contributor.authorThornicroft, Graham
dc.contributor.authorZani, Babalwa
dc.contributor.authorSelohilwe, One
dc.contributor.authorPetrus, Ruwayda
dc.contributor.authorMntambo, Ntokozo
dc.contributor.authorGeorgeu-Pepper, Daniella
dc.contributor.authorKathree, Tasneem
dc.contributor.authorLund, Crick
dc.contributor.authorLombard, Carl
dc.contributor.authorBachmann, Max
dc.contributor.authorGaziano, Thomas
dc.contributor.authorLevitt, Naomi
dc.contributor.authorFairall, Lara
dc.date.accessioned2018-05-04T10:12:47Z
dc.date.available2018-05-04T10:12:47Z
dc.date.issued2018-03-22
dc.date.updated2018-04-09T15:13:18Z
dc.description.abstractBackground 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.
dc.identifier.apacitationPetersen, I., Bhana, A., Folb, N., Thornicroft, G., Zani, B., Selohilwe, O., ... Fairall, L. (2018). 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. <i>Trials</i>, http://hdl.handle.net/11427/27935en_ZA
dc.identifier.chicagocitationPetersen, Inge, Arvin Bhana, Naomi Folb, Graham Thornicroft, Babalwa Zani, One Selohilwe, Ruwayda Petrus, et al "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." <i>Trials</i> (2018) http://hdl.handle.net/11427/27935en_ZA
dc.identifier.citationTrials. 2018 Mar 22;19(1):192
dc.identifier.ris TY - Journal Article AU - Petersen, Inge AU - Bhana, Arvin AU - Folb, Naomi AU - Thornicroft, Graham AU - Zani, Babalwa AU - Selohilwe, One AU - Petrus, Ruwayda AU - Mntambo, Ntokozo AU - Georgeu-Pepper, Daniella AU - Kathree, Tasneem AU - Lund, Crick AU - Lombard, Carl AU - Bachmann, Max AU - Gaziano, Thomas AU - Levitt, Naomi AU - Fairall, Lara AB - 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. DA - 2018-03-22 DB - OpenUCT DO - 10.1186/s13063-018-2518-6 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2018 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/27935 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-018-2518-6
dc.identifier.urihttp://hdl.handle.net/11427/27935
dc.identifier.vancouvercitationPetersen I, Bhana A, Folb N, Thornicroft G, Zani B, Selohilwe O, et al. 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; http://hdl.handle.net/11427/27935.en_ZA
dc.language.isoen
dc.publisherBioMed Central
dc.publisher.departmentDepartment of Public Health and Family Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rights.holderThe Author(s).
dc.sourceTrials
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subject.otherHypertension
dc.subject.otherDepression
dc.subject.otherPrimary health care
dc.subject.otherLow- and middle-income countries
dc.subject.otherIntegrated health care
dc.titleCollaborative 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.typeJournal Article
uct.type.filetypeText
uct.type.filetypeImage
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