Integrated Case Management for Burns Care in Pakistan
NCT Number: NCT06559501
Acronym: BURNS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unintentional Burn Injury|Depression|Anxiety|Burns
Interventions: BEHAVIORAL: Integrated case manager care
Sponsor: Pakistan Institute of Living and Learning
Collaborators: University of Manchester
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-02
Completion Date: 2026-10-31
Locations: Quetta Site, Quetta, Balochistan, Pakistan|Peshawar Site, Peshawar, KPK, Pakistan|Lahore site, Lahore, Punjab, 203393, Pakistan|Hyderabad Site, Hyderabad, Sindh, Pakistan|Civil Hospital, Karachi, Sindh, 203393, Pakistan|Rawalpindi Site, Rawalpindi, 46300, Pakistan

Summary:
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.

Primary Outcome Measures: Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D), all-cause mortality followed by readmission rates and changes in health-related quality of life, Baseline to 12th month post randomization
Secondary Outcome Measures: Patient Health Questionnaire (PHQ-9), To screen, diagnose, monitor and measure the severity of depression, Baseline to 3 months, 6 months and 12-months post-intervention|Burns Specific Health Scale, To quantify dysfunction and distress across six major domains of health, specifically burn injury related morbidity, Baseline to 3 months, 6 months and 12-months post-intervention|Rosenburg Self-Esteem Scale, A 10 item self-report instrument to measure individual self-esteem, Baseline to 3 months, 6 months and 12-months post-intervention|Visual Analogue Scale, 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, Baseline to 3 months, 6 months and 12-months post-intervention|International Trauma Questionnaire, It is a brief,18 item self-report questionnaire used to assess core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD., Baseline to 3 months, 6 months and 12-months post-intervention|Perceived Stigma Questionnaire, 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, Baseline to 3 months, 6 months and 12-months post-intervention|WHO disability assessment schedule, 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, Baseline to 3 months, 6 months and 12-months post-intervention|Vancouver Scar Scale, It is used to document change in scar appearance. Index measures the scares on four parameters, Pigmentation, vascularity, pliability and heigh, Baseline to 3 months, 6 months and 12-months post-intervention|Quality of life scale EQ-5D, Health-related quality of life as measured for mobility, self-care, usual activities, pain/discomfort and anxiety/depression, Baseline to 3 months, 6 months and 12-months post-intervention|Schedule of Clinical Assessment in Neuropsychiatry (SCAN)/Structured Clinical Interview for DSM Disorders (SCID), We will use SCAN/SCID for any psychiatric diagnosis, Baseline to 3 months, 6 months and 12-months post-intervention