Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05703711
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-01-19
Brief Title:
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
In West Africa most people with serious mental illness receive care from traditional or faith healers at prayer camps The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana
Detailed Description:
The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness The intervention has two components a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps The app is designed to provide them with training on how to deliver some psychosocial interventions monitor the health and well-being of their patients and protect human rights at the camps
The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention Throughout the study participant data will be collected at baseline mid-treatment and post-treatment Following study completion the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment
The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention Throughout the study participant data will be collected at baseline mid-treatment and post-treatment Following study completion the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH127531-01A1 | NIH | None | httpsreporternihgovquickSearch1R01MH127531-01A1 |