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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
No intentional burn injuries
• Lacking capacity to provide informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ameer Khoso, PhD Fellow | Contact | +92-2135871845 | ameer.bukhsh@pill.org.pk | |
| sehrish Tofique, PhD Fellow | Contact | +92-2135871845 | Sehrishtofique@ymail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nasim Chaudhry, MD | Pakistan Institute of Living and Learning | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burn Unit, Sandeman Provisional Hospital | Recruiting | Quetta | Balochistan | Pakistan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11556941 | Background | 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. | |
| 7131607 | 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. |
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Available on reasonable request
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D002056 | Burns |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
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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 |
| Plastic Surgery and Burn Unit, BMC, Quetta |
| Recruiting |
| Quetta |
| Balochistan |
| Pakistan |
|
| Burns and Plastic Surgery Center, Peshawar | Recruiting | Peshawar | KPK | Pakistan |
|
| Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University | Recruiting | Lahore | Punjab Province | 203393 | Pakistan |
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| Jinnah Burn & Reconstructive Surgery Centre, Lahore | Recruiting | Lahore | Punjab Province | Pakistan |
|
| Pak Italian Modern Burn and Plastic Surgery Centre | Recruiting | Multan Khurd | Punjab Province | Pakistan |
| Burn Centre, Civil Hospital Hyderabad | Recruiting | Hyderābād | Sindh | Pakistan |
|
| Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi | Recruiting | Karachi | Sindh | 203393 | Pakistan |
|
| Burns and Plastic Surgery, Patel Hospital, Karachi | Recruiting | Karachi | Sindh | Pakistan |
|
| Allied Burn & Reconstructive Surgery Centre | Recruiting | Faisalābad | Pakistan |
|
| Burn Care Centre, PIMS, Islamabad | Recruiting | Islamabad | 46300 | Pakistan |
|
| 16717171 | 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. |
| 21479777 | 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. |
| Background | Rosenberg M. Rosenberg self-esteem scale. Journal of Religion and Health. 1965 |
| 4048757 | 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. |
| 30178492 | 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. |
| 16594819 | 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. |
| Background | Üstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010. |
| 8537427 | 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. |