NCT Number: NCT06559501
To test whether a culturally adapted multicomponent intervention for improving burns care and patient/family 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 hospital/community 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Burn Unit, Sandeman Provisional Hospital, Quetta, Balochistan, Pakistan
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 given(enhanced usual care).
The intervention will be carried out by case managers (trained allied health professionals such as nurses, physiotherapists, psychologists etc) 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 hospital/community 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intentional burn injuries
comprises 8 sessions delivered by case managers. Case managers will provide up to 6 low-intensity sessions in the hospital or the community (if the patient is discharged before completing the required sessions), with content and duration tailored to patient preferences. Post-discharge, patients will receive 2 follow-up sessions with case managers to ensure a smooth transition into the community.
Time frame: Baseline to 12th month post randomization
all-cause mortality followed by readmission rates and changes in health-related quality of life
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
To screen, diagnose, monitor and measure the severity of depression
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
To quantify dysfunction and distress across six major domains of health, specifically burn injury related morbidity
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
A 10 item self-report instrument to measure individual self-esteem
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
It provides subjective magnitude estimation and consists of a straight line with limits that carry a verbal description of each extreme of the symptom both pain relief or pain severity
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
It is a brief,18 item self-report questionnaire used to assess core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD.
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
It is used to measure stigmatizing behaviors commonly reported by people with appearance distinctions. Participants were asked to rate how often they experienced a behavior on a 5-point Likert scale
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
It is used to measure the impact of health condition, functioning, disability, monitor the effectiveness of interventions as well as the burden of disease both mental and physical disorders
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
It is used to document change in scar appearance. Index measures the scares on four parameters, Pigmentation, vascularity, pliability and heigh
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Health-related quality of life as measured for mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Contact information is provided by the study sponsor or research team.
Ameer Khoso, PhD Fellow
CONTACT
sehrish Tofique, PhD Fellow
CONTACT
Pakistan Institute of Living and Learning
Other
Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
Acronym: BURNS
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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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