Primary Health Care Facilities
Dr Kenneth Kaunda District, North West, 2577, South Africa
NCT Number: NCT02425124
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Dr Kenneth Kaunda District, North West, 2577, South Africa
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinics
Exclusion criteria
Clinics
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.
Time frame: 6 Months
50 % reduction in PHQ-9 score
Time frame: 12 months
50 % reduction in the PHQ-9 score
Time frame: 12 months
Remission defined as score of <5 on PHQ9
Time frame: 6 months; 12 months
Mean PHQ9 scores
Time frame: 6 months and 12 months
Difference in means
Time frame: 12 Months
Mean score using the Manual for WHO Disability Schedule WHODAS 2.0 schedule
Time frame: 12 Months
Mean score using Perceived Stress Scale
Time frame: 12 months
Proportion with antidepressant treatment initiated or intensified
Time frame: 12 months
Proportion receiving counselling by clinic-based counsellor
Time frame: 12 months
Proportion referred
Time frame: 12 months
Proportion in care
Time frame: 12 months
Difference in means
Time frame: 12 months
Proportion diagnosed
Time frame: 12 months
Mean Patient Assessment of Care for Chronic Conditions (PACIC) score
Time frame: 12 months
Incidence rate ratio using linkage with hospitalisation databases
Time frame: 12 months
Productivity and economic outcomes
Time frame: 12 months
Proportion died
University of KwaZulu
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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