Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863572
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-04-12
Brief Title:
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAPE-U
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 eg peer helpers rather than multi-tiered collaboration in the continuum of health services eg 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None