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Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial

Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02425124
Enrollment
1052
Registered
2015-04-23
Start date
2015-04-22
Completion date
2017-07-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Hypertension

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPC101+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.

Sponsors

Department for International Development, United Kingdom
CollaboratorOTHER_GOV
University of Cape Town
CollaboratorOTHER
King's College London
CollaboratorOTHER
University of KwaZulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Clinics * Twenty (20) largest clinics providing chronic care Patients * Receiving hypertensive treatment at time of enrolment * Depressive symptoms as indicated by total score of 9 or more on PHQ-9 * Planning to reside in area for the next year * Capable of actively engaging in interviewer-administered questionnaire at time of recruitment, 6 months and 12 months later * Written consent to participate in the study

Exclusion criteria

Clinics * Clinics that do not provide Integrated Chronic Disease Management * Small (\<10 000 attendances/ year) * Mobile or satellite * Participated in piloting of intervention & data collection. Patients * Inability to meet the above inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Depression6 Months50 % reduction in PHQ-9 score

Secondary

MeasureTime frameDescription
Blood pressure6 months and 12 monthsDifference in means
Disability12 MonthsMean score using the Manual for WHO Disability Schedule WHODAS 2.0 schedule
Stress12 MonthsMean score using Perceived Stress Scale
Antidepressant treatment12 monthsProportion with antidepressant treatment initiated or intensified
Counselling12 monthsProportion receiving counselling by clinic-based counsellor
Referral to specialist mental health worker/service12 monthsProportion referred
Depression12 months50 % reduction in the PHQ-9 score
Cardiovascular risk factors12 monthsDifference in means
Diagnosis of other comorbid illnesses12 monthsProportion diagnosed
Quality of chronic illness care received12 monthsMean Patient Assessment of Care for Chronic Conditions (PACIC) score
Healthcare utilization12 monthsIncidence rate ratio using linkage with hospitalisation databases
Productivity and economic outcomes12 monthsProductivity and economic outcomes
All cause mortality12 monthsProportion died
Retention in care12 monthsProportion in care

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026