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Completed

NCT Number: NCT02425124

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Care Facilities

Dr Kenneth Kaunda District, North West, 2577, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Depression

    Time frame: 6 Months

    50 % reduction in PHQ-9 score

Secondary outcomes

  1. Depression

    Time frame: 12 months

    50 % reduction in the PHQ-9 score

  2. Depression

    Time frame: 12 months

    Remission defined as score of <5 on PHQ9

  3. Depression

    Time frame: 6 months; 12 months

    Mean PHQ9 scores

  4. Blood pressure

    Time frame: 6 months and 12 months

    Difference in means

  5. Disability

    Time frame: 12 Months

    Mean score using the Manual for WHO Disability Schedule WHODAS 2.0 schedule

  6. Stress

    Time frame: 12 Months

    Mean score using Perceived Stress Scale

  7. Antidepressant treatment

    Time frame: 12 months

    Proportion with antidepressant treatment initiated or intensified

  8. Counselling

    Time frame: 12 months

    Proportion receiving counselling by clinic-based counsellor

  9. Referral to specialist mental health worker/service

    Time frame: 12 months

    Proportion referred

  10. Retention in care

    Time frame: 12 months

    Proportion in care

  11. Cardiovascular risk factors

    Time frame: 12 months

    Difference in means

  12. Diagnosis of other comorbid illnesses

    Time frame: 12 months

    Proportion diagnosed

  13. Quality of chronic illness care received

    Time frame: 12 months

    Mean Patient Assessment of Care for Chronic Conditions (PACIC) score

  14. Healthcare utilization

    Time frame: 12 months

    Incidence rate ratio using linkage with hospitalisation databases

  15. Productivity and economic outcomes

    Time frame: 12 months

    Productivity and economic outcomes

  16. All cause mortality

    Time frame: 12 months

    Proportion died

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Collaborators

  • Department for International Development, United Kingdom
  • King's College London
  • University of Cape Town

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 23, 2015
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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