Integrated Case Management for Burns Care in Pakistan

NCT06559501 | Recruiting DMC

• 1 other identifier: PILL-BURNS-OO1
• Study Type: interventional
• Target: 1,146
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Unintentional Burn Injury; Depression; Anxiety; Burns

Keywords

Burns Rehabilitation; culturally adapted; Cost effectiveness; Multicenter trial; Pakistan; Burns Injury

Outcome Measures

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

  Baseline to 12th month post randomization

Secondary Outcomes (9)

• Patient Health Questionnaire (PHQ-9)

  Baseline to 3 months, 6 months and 12-months post-intervention

• Burns Specific Health Scale

  Baseline to 3 months, 6 months and 12-months post-intervention

• Rosenburg Self-Esteem Scale

  Baseline to 3 months, 6 months and 12-months post-intervention

• Visual Analogue Scale

  Baseline to 3 months, 6 months and 12-months post-intervention

• International Trauma Questionnaire

  Baseline to 3 months, 6 months and 12-months post-intervention

Study Arms (2)

Integrated case manager care

EXPERIMENTAL

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.

Behavioral: Integrated case manager care

Enhanced care as usual

NO INTERVENTION

includes their standard care, and all treatments recommended by attending physicians will be provided, plus a written self-help booklet

Interventions

Integrated case manager care BEHAVIORAL

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.

Integrated case manager care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No intentional burn injuries
• Lacking capacity to provide informed consent

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• University of Manchester: collaborator

Study Sites (11)

Burn Unit, Sandeman Provisional Hospital

Quetta, Balochistan, Pakistan

RECRUITING

Plastic Surgery and Burn Unit, BMC, Quetta

Quetta, Balochistan, Pakistan

RECRUITING

Burns and Plastic Surgery Center, Peshawar

Peshawar, KPK, Pakistan

RECRUITING

Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University

Lahore, Punjab Province, 203393, Pakistan

RECRUITING

Jinnah Burn & Reconstructive Surgery Centre, Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

Pak Italian Modern Burn and Plastic Surgery Centre

Multan Khurd, Punjab Province, Pakistan

RECRUITING

Burn Centre, Civil Hospital Hyderabad

Hyderābād, Sindh, Pakistan

RECRUITING

Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi

Karachi, Sindh, 203393, Pakistan

RECRUITING

Burns and Plastic Surgery, Patel Hospital, Karachi

Karachi, Sindh, Pakistan

RECRUITING

Allied Burn & Reconstructive Surgery Centre

Faisalābad, Pakistan

RECRUITING

Burn Care Centre, PIMS, Islamabad

Islamabad, 46300, Pakistan

RECRUITING

Related Publications (10)

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Blades B, Mellis N, Munster AM. A burn specific health scale. J Trauma. 1982 Oct;22(10):872-5. doi: 10.1097/00005373-198210000-00012.

  PMID: 7131607 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Rosenberg M. Rosenberg self-esteem scale. Journal of Religion and Health. 1965

  BACKGROUND

• Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.

  PMID: 4048757 BACKGROUND

• Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.

  PMID: 30178492 BACKGROUND

• Lawrence JW, Fauerbach JA, Heinberg LJ, Doctor M, Thombs BD. The reliability and validity of the Perceived Stigmatization Questionnaire (PSQ) and the Social Comfort Questionnaire (SCQ) among an adult burn survivor sample. Psychol Assess. 2006 Mar;18(1):106-11. doi: 10.1037/1040-3590.18.1.106.

  PMID: 16594819 BACKGROUND

• Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.

  BACKGROUND

• Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013.

  PMID: 8537427 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Burns

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Wounds and Injuries

Study Officials

• Nasim Chaudhry, MD

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ameer Khoso, PhD Fellow

CONTACT

+92-2135871845; ameer.bukhsh@pill.org.pk

sehrish Tofique, PhD Fellow

CONTACT

+92-2135871845; Sehrishtofique@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (11)