Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1146 participants
INTERVENTIONAL
2024-09-02
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Integrated case manager care
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
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.
Enhanced care as usual
includes their standard care, and all treatments recommended by attending physicians will be provided, plus a written self-help booklet
No interventions assigned to this group
Interventions
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Integrated case manager care
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.
Eligibility Criteria
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Inclusion Criteria
* Accidental burn injury and meet the criteria for admission to burn centres
* Clinician judgment for participation readiness
* Ability to provide informed consent
Exclusion Criteria
• Lacking capacity to provide informed consent
18 Years
ALL
No
Sponsors
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University of Manchester
OTHER
Pakistan Institute of Living and Learning
OTHER
Responsible Party
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Principal Investigators
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Nasim Chaudhry, MD
Role: PRINCIPAL_INVESTIGATOR
Pakistan Institute of Living and Learning
Locations
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Burn Unit, Sandeman Provisional Hospital
Quetta, Balochistan, Pakistan
Plastic Surgery and Burn Unit, BMC, Quetta
Quetta, Balochistan, Pakistan
Burns and Plastic Surgery Center, Peshawar
Peshawar, KPK, Pakistan
Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University
Lahore, Punjab Province, Pakistan
Jinnah Burn & Reconstructive Surgery Centre, Lahore
Lahore, Punjab Province, Pakistan
Pak Italian Modern Burn and Plastic Surgery Centre
Multan Khurd, Punjab Province, Pakistan
Burn Centre, Civil Hospital Hyderabad
Hyderābād, Sindh, Pakistan
Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
Karachi, Sindh, Pakistan
Burns and Plastic Surgery, Patel Hospital, Karachi
Karachi, Sindh, Pakistan
Allied Burn & Reconstructive Surgery Centre
Faisalābad, , Pakistan
Burn Care Centre, PIMS, Islamabad
Islamabad, , Pakistan
Countries
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Central Contacts
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Facility Contacts
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Dr Silsila Sherzad, MBBS
Role: primary
Irfan Ullah
Role: primary
Mustehsan Bashir
Role: primary
Farrukh Aslam, FCPS
Role: primary
Saadia Rasheed
Role: primary
Samia Tasleem
Role: primary
Mazhar Nizam, FCPS
Role: primary
Urwa Ahmed
Role: primary
Rehan Ahmed, MBBS
Role: primary
References
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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.
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.
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.
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.
Rosenberg M. Rosenberg self-esteem scale. Journal of Religion and Health. 1965
Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
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.
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.
Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.
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.
Other Identifiers
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PILL-BURNS-OO1
Identifier Type: -
Identifier Source: org_study_id
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