Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559501
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Integrated Case Management for Burns Care in Pakistan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BURNS
Brief Summary:
To test whether a culturally adapted multicomponent intervention for improving burns care and patientfamily rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective The comparator will be usual care plus brief written self-help advice enhanced usual care The study is designed as a multicentre pragmatic parallel group individually randomised trial Participants in the intervention arm will receive 8 sessions delivered by the case managers 6 low-intensity sessions lasting 30-60 minutes in the hospitalcommunity and 2 follow-up sessions lasting 30 minutes in the community Assessments will be conducted at baseline at 3 months 6 months and at 12-months post-intervention
Detailed Description:
The Burns trial will be conducted in six cities of Pakistan Karachi Hyderabad Lahore Rawalpindi Peshawar and Quetta to compare integrated intervention with enhanced usual care Participants will be randomized either to the intervention or enhanced usual care The intervention consists of multiple culturally adapted components such as psychological bundle emergency care surgical and rehab bundle to improve care within burn units transitional care and patient and family rehabilitation known as Integrated case management for improved psychosocial and physical rehabilitation of burn survivors and their families The comparator will be usual care emergency surgical and rehab care plus brief written self-help booklets will be givenenhanced usual care
The intervention will be carried out by case managers trained nursing staff and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers
Participants in the intervention arm will receive 8 sessions delivered by the case managers 6 low-intensity sessions lasting 30-60 minutes in the hospitalcommunity and 2 follow-up sessions lasting 30 minutes in the community Assessments will be conducted at baseline at 3 months 6 months and at 12-months post-intervention
The intervention will be carried out by case managers trained nursing staff and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers
Participants in the intervention arm will receive 8 sessions delivered by the case managers 6 low-intensity sessions lasting 30-60 minutes in the hospitalcommunity and 2 follow-up sessions lasting 30 minutes in the community Assessments will be conducted at baseline at 3 months 6 months and at 12-months post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None