Unintentional Burn InjuryBURNSNCT06559501
Integrated Case Management for Burns Care in Pakistan
A study testing Integrated case manager care in people with Unintentional Burn Injury and Depression, run by Pakistan Institute of Living and Learning at 11 sites in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unintentional Burn Injury, Depression, Anxiety
- What is being tested?
- Integrated case manager care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 11 sitesPakistan
- Study dates
- 2 Sep 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No intentional burn injuries
- Lacking capacity to provide informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Pakistan11 sites
Allied Burn & Reconstructive Surgery Centre
Faisalābad
Burn Centre, Civil Hospital Hyderabad
Hyderābād, Sindh
Burn Care Centre, PIMS, Islamabad
Islamabad, 46300
Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi
Karachi, Sindh, 203393
Burns and Plastic Surgery, Patel Hospital, Karachi
Karachi, Sindh
Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University
Lahore, Punjab Province, 203393
Jinnah Burn & Reconstructive Surgery Centre, Lahore
Lahore, Punjab Province
Pak Italian Modern Burn and Plastic Surgery Centre
Multan Khurd, Punjab Province
Burns and Plastic Surgery Center, Peshawar
Peshawar, KPK
Burn Unit, Sandeman Provisional Hospital
Quetta, Balochistan
Plastic Surgery and Burn Unit, BMC, Quetta
Quetta, Balochistan
About this study
Official title: Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
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.
Read the detailed description
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.
- Conditions
- Unintentional Burn Injury, Depression, Anxiety, Burns
- Being tested
- Integrated case manager care
- Keywords
- Burns Rehabilitation, culturally adapted, Cost effectiveness, Multicenter trial, Pakistan, Burns Injury
- Medical subject headings
- Depression, Anxiety Disorders, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated case manager careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 12th month post randomization
Secondary outcomes (9)
Patient Health Questionnaire (PHQ-9)
To screen, diagnose, monitor and measure the severity of depression
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 3 months, 6 months and 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start2 Sep 2024
- Primary completion30 Jun 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Unintentional Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, MD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559501
- Sponsor's protocol ID
- PILL-BURNS-OO1
- Acronym
- BURNS
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on reasonable request
Publications
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.
PubMed 11556941Blades B, Mellis N, Munster AM. A burn specific health scale. J Trauma. 1982 Oct;22(10):872-5. doi: 10.1097/00005373-198210000-00012.
PubMed 7131607Spitzer 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.
PubMed 16717171Herdman 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.
PubMed 21479777Rosenberg 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.
PubMed 4048757Cloitre 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.
PubMed 30178492Lawrence 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.
PubMed 16594819Üstün 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.
PubMed 8537427
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan
- ClinicalTrials.gov ID
- NCT06559501
- Acronym / sponsor ID
- BURNS / PILL-BURNS-OO1
- Conditions
- Unintentional Burn Injury, Depression, Anxiety, Burns
- Keywords
- Burns Rehabilitation, culturally adapted, Cost effectiveness, Multicenter trial, Pakistan, Burns Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated case manager care | Experimental | Behavioral: Integrated case manager carecomprises 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No intentional burn injuries
- Lacking capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated case manager carecomprises 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. | Behavioural | Integrated case manager care |
Primary outcome
Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)
Time frame: Baseline to 12th month post randomization
all-cause mortality followed by readmission rates and changes in health-related quality of life
9 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Burns Specific Health Scale
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Rosenburg Self-Esteem Scale
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Visual Analogue Scale
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
International Trauma Questionnaire
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Perceived Stigma Questionnaire
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
WHO disability assessment schedule
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Vancouver Scar Scale
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Quality of life scale EQ-5D
Time frame: Baseline to 3 months, 6 months and 12-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 7131607Blades B, Mellis N, Munster AM. A burn specific health scale. J Trauma. 1982 Oct;22(10):872-5. doi: 10.1097/00005373-198210000-00012.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 21479777Herdman 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.
- BackgroundRosenberg M. Rosenberg self-esteem scale. Journal of Religion and Health. 1965
- Background: PubMed 4048757Langley GB, Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985;5(4):145-8. doi: 10.1007/BF00541514.
- Background: PubMed 30178492Cloitre 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.
- Background: PubMed 16594819Lawrence 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.
- BackgroundÜstün TB. Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0: World Health Organization; 2010.
- Background: PubMed 8537427Baryza 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.
- Individual participant dataSharing planned: No. Available on reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry, MD principal investigator
Pakistan Institute of Living and Learning
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated case manager care in people with Unintentional Burn Injury and Depression, run by Pakistan Institute of Living and Learning at 11 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D) (time frame: Baseline to 12th month post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06559501, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.