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| Name | Class |
|---|---|
| Department for International Development, United Kingdom | OTHER_GOV |
| University of Cape Town | OTHER |
| King's College London | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC101+Mental Health | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | 50 % reduction in PHQ-9 score | 6 Months |
| 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 |
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Inclusion Criteria:
Clinics
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Health Care Facilities | Dr Kenneth Kaunda District | North West | 2577 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33412490 | Derived | 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. | |
| 29566730 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
| Derived |
| 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. |