Integrated Case Management for Burns Care in Pakistan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPakistan Institute of Living and Learning
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18 years and over
Accidental burn injury and meet the criteria for admission to burn centres
Clinician judgment for participation readiness
Ability to provide informed consent
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Integrated case manager care
Behavioralcomprises 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.
Treatment groups
1,146 Participants
are divided into 2 treatment groupsGroup A: Integrated case manager careExperimental treatment 1 intervention
Group B: Enhanced care as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline to 12th month post randomizationSecondary outcomes
1
Patient Health Questionnaire (PHQ-9)
To screen, diagnose, monitor and measure the severity of depression
Time frame
Baseline to 3 months, 6 months and 12-months post-intervention2
Burns Specific Health Scale
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-intervention3
Rosenburg Self-Esteem Scale
A 10 item self-report instrument to measure individual self-esteem
Time frame
Baseline to 3 months, 6 months and 12-months post-intervention4
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
Time frame
Baseline to 3 months, 6 months and 12-months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pakistan Institute of Living and Learning
Lead sponsor
University of Manchester
Collaborator
Source ClinicalTrials.gov