Clinical trial NCT02425124: Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
Official title: Strengthening Mental Health Care in Chronic Care Patients With Hypertension. A Cluster Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Hypertension
Lead sponsor: University of KwaZulu
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
name: University of Cape Town
name: King's College London
First posted: 2015-04-23
Enrollment: 1052
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: 6 Months
Secondary outcomes:
measure: Depression
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Depression
timeFrame: 6 months; 12 months
measure: Blood pressure
timeFrame: 6 months and 12 months
measure: Disability
timeFrame: 12 Months
measure: Stress
timeFrame: 12 Months
measure: Antidepressant treatment
timeFrame: 12 months
measure: Counselling
timeFrame: 12 months
measure: Referral to specialist mental health worker/service
timeFrame: 12 months
measure: Retention in care
timeFrame: 12 months
measure: Cardiovascular risk factors
timeFrame: 12 months
measure: Diagnosis of other comorbid illnesses
timeFrame: 12 months
measure: Quality of chronic illness care received
timeFrame: 12 months
measure: Healthcare utilization
timeFrame: 12 months
measure: Productivity and economic outcomes
timeFrame: 12 months
measure: All cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Dr Kenneth Kaunda District
country: South Africa
facility: Primary Health Care Facilities
state: North West Province
Study officials:
affiliation: University of KwaZulu
name: Inge Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Lara R Fairall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Graham Thornicroft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.