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Clinical Trials/NCT05863572
NCT05863572
Recruiting
N/A

Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda

George Washington University1 site in 1 country132 target enrollmentSeptember 5, 2023
ConditionsPsychosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosis
Sponsor
George Washington University
Enrollment
132
Locations
1
Primary Endpoint
Positive and Negative Symptoms of Schizophrenia (PANSS) scale
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

Background: Mental health services are most effective and equitable when designed, delivered, and evaluated in collaboration with people with lived experience of mental health conditions. Unfortunately, people with lived experience are rarely involved in health systems strengthening or are limited to specific components (e.g., peer helpers) rather than multi-tiered collaboration in the continuum of health services (e.g., ranging from home- to community- to clinic-based services). Moreover, programs that do involve people with lived experience, typically involve people with a history of a substance use conditions or common mental disorders. In contrast, the collaboration of people with lived experience of psychosis is especially rare. A pilot cluster randomized controlled trial will be conducted in urban and peri-urban areas around Kampala, Uganda, to evaluate the benefits of an implementation strategy for mental health services with engagement of people with lived experience of psychosis throughout the home-to-community-to-clinic care continuum, this is a hybrid type-III implementation-effectiveness pilot focusing on the differences in implementation strategy. This implementation strategy, entitled "Strengthening CAre in collaboration with People with lived Experience of psychosis in Uganda", will include training people with lived experience of psychosis using PhotoVoice and other methods to participate at three levels: in-home services, community engagement, and primary health care facilities. The investigators will compare a standard task-sharing implementation arm using training by mental health specialists with an experimental implementation arm that includes collaboration with people with lived experience. The primary objective is to evaluate the feasibility and acceptability of this strategy in the context of assuring safety and wellbeing of people with lived experience of psychosis who collaborate in health systems strengthening. By collaborating on health systems strengthening across these multiple levels, we foresee a more in-depth contribution that can lead to rethinking how best to design and deliver care for people with lived experience of psychosis. Successful completion of this pilot will be the foundation for a fully powered trial to evaluate the benefits of multi-level collaboration with people with lived experience of psychosis.

Detailed Description

The aim of the current study is to conduct a pilot cluster randomized controlled trial to determine feasibility and acceptability of people with lived experience of psychosis collaborating in training primary care and community health care workers and co-delivering services in the home. This pilot study will consist of two trial arms: - Training- As- Usual vs the experimental arm. It will be implemented across three-tiers - in primary health care, community, and home settings. The pilot will also determine the parameters needed for appropriate design and implementation of a fully-power future cluster randomized controlled trial. Objective 1 - To assess the feasibility and acceptability of the implementation strategy from the perspective of people with lived experience of psychosis, family members and primary and community care providers. Objective 2 - To demonstrate proof-of-concept for the benefit of the implementation strategy for service users (i.e., patients with psychosis receiving primary care services) and their families, including changes in psychosis symptoms, quality of life, frequency of hospitalization and the potential impacts on family members. Objective 3 - To evaluate changes in health systems outcomes in terms of primary care provider knowledge, attitudes, competency in psychosis diagnosis and management, accuracy of diagnosis and fidelity to treatment guidelines in actual care settings as well as trial procedures. Objective 4: To evaluate costing, recruitment and retention, and data collection procedures and protocols to determine the optimal design for a future fully powered cluster Randomized Controlled Trial. Objective 5: To establish and demonstrate ethics and safety in collaborating with service users.

Registry
clinicaltrials.gov
Start Date
September 5, 2023
End Date
April 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brandon A Kohrt, MD, PhD

Professor

George Washington University

Eligibility Criteria

Inclusion Criteria

  • Facilitators of the implementation strategy:
  • At least 18 years of age
  • Confirmed diagnosis of a primary psychotic disorder (e.g., schizophrenia) by a psychiatrist or psychiatric clinical officer
  • Completion of the YouBelongHOME (YBH) program
  • Provision of informed consent,
  • Fluency in the local language (Luganda)
  • Good functioning with respect to performance of daily chores,engagement with family members, comprehension and community participation as assessed by the YBH team
  • A supportive family member.
  • Primary care providers:
  • Provides primary care in health facility of Kampala/Wakiso District

Exclusion Criteria

  • Facilitators of the implementation strategy:
  • a. Inability to provide informed consent.
  • Primary care providers:
  • Community health workers:
  • Persons diagnosed with psychosis requiring inpatient management/services; and
  • Persons for whom consent for participation in the study cannot be obtained.
  • Patients found to be severely ill beyond the capacity of the health facility to treat.
  • Family members a. Family members who doesn't provide consent for participation

Outcomes

Primary Outcomes

Positive and Negative Symptoms of Schizophrenia (PANSS) scale

Time Frame: 8 months post enrollment

Symptoms of Psychosis, minimum = 0, maximum = 56, higher score is worse

Secondary Outcomes

  • Discrimination and Stigma Scale-Brief version(8 months post enrollment)
  • World Health Organization Quality of Life-Brief Scale(8 months post enrollment)
  • Service user collaboration checklist(8 months post enrollment)
  • EuroQuality of Life 5-Dimension 5-Level(8 months post enrollment)
  • Social Inclusion Scale(8 months post enrollment)
  • Hospitalization Record(8 months post enrollment)
  • Client Service Receipt Inventory(8 months post enrollment)
  • Family Interview Schedule-Impact on Caregivers(8 months post enrollment)
  • Community Health Workers: Social Distance Scale(immediately after training)
  • Community Health Workers: Assessment tool(monthly throughout the study period : average of 8 months, However accuracy check during SCID diagnosis check)
  • Primary care workers: Mental health Gap Action Program Knowledge(final supervision: 8 months post training)
  • Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 5(3 months post patient enrollment)
  • Primary care workers: Enhancing Assessment of Common Therapeutic factors for Psychosis(final supervision - 8 months post training)
  • Community Health Workers: Village health team referral(monthly throughout the study period (average of 8 months), starts immediately after training)
  • Community Health Workers: Village health team referral with psychosis(monthly throughout the study period (average of 8 months), starts immediately after training)
  • Primary care workers: Social Distance Scale(final supervision: 8 months post training)
  • Health Facility Record(final supervision - 8 months post training)

Study Sites (1)

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