Burns MultipleNCT04517721
Effects of a Nurse-led Transitional Burns Rehabilitation Programme
A study testing Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) in people with Burns Multiple, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The number of adult burn survivors is increasing gradually, and attention is drawn towards how they can be supported during the transitioning period. Considering the impact of nurse-led programmes in chronic disease management, it is being argued that an appropriate nurse-led bridging transitional programme of care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns Multiple
- What is being tested?
- Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged ≥18 years
- Burn size ≥10% TBSA
- Reachable on phone and WeChat
- Absence of confirmed psychiatric condition
- Absence of confirmed chronic diagnosis of renal failure or diabetes mellitus with foot ulcers
Who cannot join
- Unable to communicate Not reachable via phone Confirmed underlying psychiatry or renal failure or diabetes mellitus with foot ulcers Already engaged in another burn rehabilitation programme Will not reside in the specified location within three months of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Nurse-led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) for Adult Burn Survivors at the Gansu Provincial Hospital, Lanzhou: A Randomised Controlled Trial
The number of adult burn survivors is increasing gradually, and attention is drawn towards how they can be supported during the transitioning period. Considering the impact of nurse-led programmes in chronic disease management, it is being argued that an appropriate nurse-led bridging transitional programme of care may be an essential extended/ add-on service for adult burn survivors. Guided by the Medical Research Council Framework for Complex Interventions, a nurse-led programme has been developed. This phase seeks to implement the intervention, evaluate its effects, and understand the mechanisms of implementation at the Gansu Provincial Hospital, Lanzhou.
A randomized controlled trial approach with a nested process evaluation phase will be used. Participants will be recruited from the Burn Unit of the Gansu Provincial Hospital, Lanzhou and the intervention commenced from at least 72 hours to discharge up to 2 months post-discharge. Participants will be randomized to either control or treatment group using a blinded approach. Following the completion of the intervention, up to 15 participants will be recruited for face to face interviews.
Read the detailed description
Recovery following burn injury is a complex process which involves re-fitting one's new form into an already known world. The aftermath of burns and complex responses by affected persons makes it difficult to map a clear recovery pathway. At the initial phase of recovery, the patient may show several responses such as disbelief, fear, and pain. These responses may become more pronounced as the patient comes to terms with the losses associated with injury. Further challenges associated with appearance changes and function may accrue as healing progresses and the scars evolve through maturation. Subsequently by discharge, burn survivors need to adapt to a new situation as they return to the community and assume full responsibility of their care. Hospital discharge, therefore, does not imply an end to treatment but a transitional period when the burn patient is still coming to terms with the reality of the injury, identifying new approaches to thriving and adapting to the changes thereof. To facilitate this ongoing recovery of adult burn survivors, there is therefore a need for continuous contact with rehabilitation services to ensure that needs that emerge in the process are identified and actively resolved.
Considering the importance of rehabilitation in the recovery process of the adult burn patient, it becomes essential to ensure that all burn patients receive rehabilitative care as and when needed. However, burn rehabilitation practices vary across settings. In developed countries, the burn patients often undergo intensive rehabilitation concurrently with acute care and later stepped down to continue an inpatient rehabilitation programme before discharge. In contrast, burn centres in developing countries may not have such step down services to a unique inpatient rehabilitation service; thus, the patient benefits only from the rehabilitation service that occurs alongside acute care and thereafter discharged home. Pressure on beds and limited financial resources in some developing settings may also trigger early discharge from the burn unit which further shortens the patient's contact with rehabilitation services.
In Mainland China, the concept of rehabilitation is still under development, not commonly practiced and where available, burn patients may face limited access due to inadequate personnel. The escalating chronic disease burden and ageing population further leaves limited resources allocated to burns rehabilitation in Mainland China. Even in healthcare facilities with rehabilitation services, the cultural belief among Chinese citizens that rehabilitation is a natural outcome of diseases, rather than an active management of dysfunctional issues of the body may affect the level of service utilization. Previous studies in Mainland China have also highlighted the significant focus on medical management of burn injuries with limited attention to comprehensive rehabilitative support. Thus, at the time of discharge the adult burn survivors may not have received adequate rehabilitative support commensurate with their needs and have to live with serious disabilities.
As the adult burn survivor transitions from the hospital to the community, anxiety and uncertainties may ensue. Other emotional responses may become more pronounced as the adult burn survivor comes to terms with the injury and the losses associated with it. Thus, the adult burn survivor transitions to the early post-discharge period with several physical, psychological, and social needs whilst at the same time, they are expected to assume full responsibility for their care. By 3 months post-discharge, burn survivors experience increasing psychological burden, poor physical role performances and poor quality of life. Within 6 months to 1 year post-discharge without professional support, the adult burn patient may experience further emotional distress reflected by the high rates of depression, sleep disturbance, body image concerns and sexual problems. Although statistically insignificant, several studies have reported an improvement in burn-specific health beyond 1year post-burn. Besides, psychosocial distress may still persist by 9 years post-discharge. These strengthen the need for ongoing comprehensive and continuous care to facilitate early identification and resolution of biopsychosocial needs that may emerge; a care pathway similar to persons living with chronic conditions.
Along the recovery trajectory for adult burn survivors, findings from several studies suggest that the greatest physical and psychosocial decline may be experienced by 2-3 months post-discharge. This assertion implies that the discharge to early post-discharge period, that is, 2 months following discharge represent a vulnerable period which can impact adversely on the long-term recovery outcomes of adult burn survivors. The period has been described as unpredictable with the emergence of varied needs requiring an individualized approach to care on regular basis than is provided by interval outpatient clinic visits. Despite these assertions, it is around this period that professional support may be limited or unavailable and some adult burn survivors may not return to the hospital due to issues such as long travel distances and associated costs. These raise an interest regarding how professional support can be organized and delivered as the patient transitions to the early post-discharge period in the home or community to ensure that they receive the sustained and comprehensive rehabilitative support. Thus, the current study to develop a nurse-led transitional rehabilitation programme and evaluate its effects among adult burn survivors.
- Conditions
- Burns Multiple
- Being tested
- Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)Other
The nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) is presented as an 8-week interventional programme that supports holistic care for adult burn survivors led by a specialist burn care nurse and supported by the burn care team. The intervention posits that as the adult burn survivor transitions, several physiological, psychosocial, health-related behaviour and environmental needs emerge which lead to poor quality of life. Despite this, they may be unable to return to utilise available healthcare services or have inadequate contact with rehabilitation services. To facilitate their recovery and enhance the attainment of rehabilitation outcomes, the 4Cs-TBuRP views the burn care nurse as the link between rehabilitation services and the adult burn survivor. Thus, the burn care nurse serves as the coordinator of care and actively collaborates with the burn care team and the patient/ family to ensure that continuous care is delivered in a timely manner.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The 4C's-TBuRP for adult burn survivors comprises of two phases:
* Phase 1: Discharge planning/ preparation and day of discharge (Comprehensive assessment and evaluation, Education, guidance, and counselling, Treatment and procedures, Case management (referral for nursing follow-up), multi-disciplinary follow-up and Surveillance)
* Phase 2: Follow-up Phase (2 WeChat Telehealth, 6 structured telephone follow-ups and daytime patient/ family-initiated telephone service; home visit based on meeting criteria) over an 8-week follow-up with delivery of rehabilitation care across the spectrum by trained nurse case managers ongoing assessment, intervention using the Omaha System and delivery of evidence-based care. Receives: Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) |
| Control group | Active comparator | Participants in the control group will receive the care at the discharge planning phase and thereafter continue to utilise the exiting service available at the hospital, that is, medical review in the hospital. Receives: Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D.
The Burn Specific Health Scale-Brief comprises of 40 questions, 9 sub-scales, and 3 domains (physical, mental, and social). Each item is scored on a 5-point scale ranging from 0 (extremely) to 4 (not at all). The maximum score is 140. Lower scores suggest poor quality of life and higher scores imply good quality of life. Internal consistency of the total instrument has been reported to be α=0.94 with test-retest reliability suggesting that the Intraclass Correlation Coefficient (ICC) ranged from 0.81 to 0.96 with a total score of 0.93. The 5-level EQ-5D has five response levels: level 1 (no problem) to level 5 (extreme problem). The possible health states are defined by combining one level from each dimension. An EQ-5D-5L index value is calculated ranging from 0 (death) to 1 (full health). Decreasing scores therefore suggest poor health whilst increasing scores suggest good health.
Measured: Three months
Secondary outcomes (5)
Chinese version of the Hospital Anxiety and Depression Scale
The 14-item Hospital Anxiety and Depression Scale was designed as a tool to screen for anxiety and depressive symptoms in medical settings, and has well-demonstrated solid psychometric properties for use in medical settings and commonly used in burn care settings to screen anxiety and depression. The total score is 42 (21 per subscale). Scores per subscale can range from 0-21. Higher scores indicate greater levels of anxiety and depression and lower scores imply low levels of anxiety and depression.
Measured: Three months
Chinese version of the Pittsburgh Sleep Quality Index
The Chinese version of the Pittsburgh Sleep Quality Index is a widely recognized instrument used to evaluate the quality of sleep. It includes 19 items with a total score that ranges from 0 to 21. A higher PSQI score implies poorer quality of sleep and lower scores imply good sleep patterns. In general, a PSQI score greater than 5 is considered to indicate poor sleep quality.
Measured: Three months
Chinese version of the Brief Pain Inventory
: The Chinese version of the Brief Pain Inventory will be used to evaluate pain among participants. It has 15 items, of which 11 items have numeric rating scale, on the experience of pain, the area of severe pain, the presence of pain, minimum and maximum pain on the previous day, current pain level, analgesia and pain relief, and the interference of pain on the patient's functioning. Pain severity and interference scores are calculated out of a total score of 10. Higher scores represent increasing pain severity and interference.
Measured: Three months
Chinese version of a visual analogue scale
The Chinese version of a visual analogue scale will be used to evaluate this itch intensity among participants. Intraclass correlation coefficient has been recorded as 0.88 (Reich et al., 2012). The tool ranges from 0 (no itch) to 10 (worst imaginable itch). Thus, increasing scores represent worsening itch.
Measured: Three months
Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH)
The DASH tool is a 30-item questionnaire that asks the patient to grade symptoms and physical function during the preceding week on a five-point Likert scale. The reliability of the DASH is excellent (intraclass correlation coefficient 0.97 with Cronbach's alpha of 0.97. The tool is scored from 0 (no disability) to 100. Increasing scores suggest the existence of a disability.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Dec 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Burns MultipleStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Model description
- Eligible participants will be randomised to either the control or intervention groups with the former receiving the existing care at the hospital and the latter receiving the both the new intervention and existing standard of care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Kam Yuet WONG, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517721
- Sponsor's protocol ID
- HSEARS20200730001
- Status last verified
- Jun 2022
- First submitted
- 14 Aug 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albarran, J. (2005). Response to editorial: Nurse led care. British Medical Journal (BMJ), 330, 682-683.
Brusselaers N, Monstrey S, Vogelaers D, Hoste E, Blot S. Severe burn injury in Europe: a systematic review of the incidence, etiology, morbidity, and mortality. Crit Care. 2010;14(5):R188. doi: 10.1186/cc9300. Epub 2010 Oct 19.
PubMed 20958968Chinese Burn Association; Chinese Association of Burn Surgeons; Cen Y, Chai J, Chen H, Chen J, Guo G, Han C, Hu D, Huan J, Huang X, Jia C, Li-Tsang CW, Li J, Li Z, Liu Q, Liu Y, Luo G, Lv G, Niu X, Peng D, Peng Y, Qi H, Qi S, Sheng Z, Tang D, Wang Y, Wu J, Xia Z, Xie W, Yang H, Yi X, Yu L, Zhang G; Chinese Burn Care and Rehabilitation Association. Guidelines for burn rehabilitation in China. Burns Trauma. 2015 Oct 21;3:20. doi: 10.1186/s41038-015-0019-3. eCollection 2015.
PubMed 27574666Christiaens W, Van de Walle E, Devresse S, Van Halewyck D, Benahmed N, Paulus D, Van den Heede K. The view of severely burned patients and healthcare professionals on the blind spots in the aftercare process: a qualitative study. BMC Health Serv Res. 2015 Aug 1;15:302. doi: 10.1186/s12913-015-0973-2.
PubMed 26231290Evers LH, Bhavsar D, Mailander P. The biology of burn injury. Exp Dermatol. 2010 Sep;19(9):777-83. doi: 10.1111/j.1600-0625.2010.01105.x. Epub 2010 Jul 14.
PubMed 20629737Gerber LH, Bush H, Holavanahalli R, Esselman P, Schneider J, Heinemann A, Garfinkel S, Cai C. A scoping review of burn rehabilitation publications incorporating functional outcomes. Burns. 2019 Aug;45(5):1005-1013. doi: 10.1016/j.burns.2018.09.029. Epub 2018 Oct 26.
PubMed 31203869Gullick JG, Taggart SB, Johnston RA, Ko N. The trauma bubble: patient and family experience of serious burn injury. J Burn Care Res. 2014 Nov-Dec;35(6):e413-27. doi: 10.1097/BCR.0000000000000030.
PubMed 25144806Hundeshagen G, Suman OE, Branski LK. Rehabilitation in the Acute Versus Outpatient Setting. Clin Plast Surg. 2017 Oct;44(4):729-735. doi: 10.1016/j.cps.2017.05.004. Epub 2017 Jul 28.
PubMed 28888298Jagnoor J, Lukaszyk C, Fraser S, Chamania S, Harvey LA, Potokar T, Ivers RQ. Rehabilitation practices for burn survivors in low and middle income countries: A literature review. Burns. 2018 Aug;44(5):1052-1064. doi: 10.1016/j.burns.2017.10.007. Epub 2017 Dec 28.
PubMed 29290511Kornhaber R, Rickard G, McLean L, Wiechula R, Lopez V, Cleary M. Burn care and rehabilitation in Australia: health professionals' perspectives. Disabil Rehabil. 2019 Mar;41(6):714-719. doi: 10.1080/09638288.2017.1406009. Epub 2017 Dec 5.
PubMed 29207887Lotfi M, Ghahremaneian A, Aghazadeh A, Jamshidi F. The Effect of Pre-Discharge Training on the Quality of Life of Burn Patients. J Caring Sci. 2018 Jun 1;7(2):107-112. doi: 10.15171/jcs.2018.017. eCollection 2018 Jun.
PubMed 29977882McAleavey AA, Wyka K, Peskin M, Difede J. Physical, functional, and psychosocial recovery from burn injury are related and their relationship changes over time: A Burn Model System study. Burns. 2018 Jun;44(4):793-799. doi: 10.1016/j.burns.2017.12.011. Epub 2018 Feb 1.
PubMed 29395409Procter F. Rehabilitation of the burn patient. Indian J Plast Surg. 2010 Sep;43(Suppl):S101-13. doi: 10.4103/0970-0358.70730.
PubMed 21321643Richmond TS, Thompson HJ, Deatrick JA, Kauder DR. Journey towards recovery following physical trauma. J Adv Nurs. 2000 Dec;32(6):1341-7. doi: 10.1046/j.1365-2648.2000.01629.x.
PubMed 11136401Schneider JC, Qu HD, Lowry J, Walker J, Vitale E, Zona M. Efficacy of inpatient burn rehabilitation: a prospective pilot study examining range of motion, hand function and balance. Burns. 2012 Mar;38(2):164-71. doi: 10.1016/j.burns.2011.11.002. Epub 2011 Nov 25.
PubMed 22119446
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nurse-led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) for Adult Burn Survivors at the Gansu Provincial Hospital, Lanzhou: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04517721
- Acronym / sponsor ID
- HSEARS20200730001
- Conditions
- Burns Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 Aug 2020 (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.
The number of adult burn survivors is increasing gradually, and attention is drawn towards how they can be supported during the transitioning period. Considering the impact of nurse-led programmes in chronic disease management, it is being argued that an appropriate nurse-led bridging transitional programme of care may be an essential extended/ add-on service for adult burn survivors. Guided by the Medical Research Council Framework for Complex Interventions, a nurse-led programme has been developed. This phase seeks to implement the intervention, evaluate its effects, and understand the mechanisms of implementation at the Gansu Provincial Hospital, Lanzhou.
A randomized controlled trial approach with a nested process evaluation phase will be used. Participants will be recruited from the Burn Unit of the Gansu Provincial Hospital, Lanzhou and the intervention commenced from at least 72 hours to discharge up to 2 months post-discharge. Participants will be randomized to either control or treatment group using a blinded approach. Following the completion of the intervention, up to 15 participants will be recruited for face to face interviews.
Detailed description
Recovery following burn injury is a complex process which involves re-fitting one's new form into an already known world. The aftermath of burns and complex responses by affected persons makes it difficult to map a clear recovery pathway. At the initial phase of recovery, the patient may show several responses such as disbelief, fear, and pain. These responses may become more pronounced as the patient comes to terms with the losses associated with injury. Further challenges associated with appearance changes and function may accrue as healing progresses and the scars evolve through maturation. Subsequently by discharge, burn survivors need to adapt to a new situation as they return to the community and assume full responsibility of their care. Hospital discharge, therefore, does not imply an end to treatment but a transitional period when the burn patient is still coming to terms with the reality of the injury, identifying new approaches to thriving and adapting to the changes thereof. To facilitate this ongoing recovery of adult burn survivors, there is therefore a need for continuous contact with rehabilitation services to ensure that needs that emerge in the process are identified and actively resolved.
Considering the importance of rehabilitation in the recovery process of the adult burn patient, it becomes essential to ensure that all burn patients receive rehabilitative care as and when needed. However, burn rehabilitation practices vary across settings. In developed countries, the burn patients often undergo intensive rehabilitation concurrently with acute care and later stepped down to continue an inpatient rehabilitation programme before discharge. In contrast, burn centres in developing countries may not have such step down services to a unique inpatient rehabilitation service; thus, the patient benefits only from the rehabilitation service that occurs alongside acute care and thereafter discharged home. Pressure on beds and limited financial resources in some developing settings may also trigger early discharge from the burn unit which further shortens the patient's contact with rehabilitation services.
In Mainland China, the concept of rehabilitation is still under development, not commonly practiced and where available, burn patients may face limited access due to inadequate personnel. The escalating chronic disease burden and ageing population further leaves limited resources allocated to burns rehabilitation in Mainland China. Even in healthcare facilities with rehabilitation services, the cultural belief among Chinese citizens that rehabilitation is a natural outcome of diseases, rather than an active management of dysfunctional issues of the body may affect the level of service utilization. Previous studies in Mainland China have also highlighted the significant focus on medical management of burn injuries with limited attention to comprehensive rehabilitative support. Thus, at the time of discharge the adult burn survivors may not have received adequate rehabilitative support commensurate with their needs and have to live with serious disabilities.
As the adult burn survivor transitions from the hospital to the community, anxiety and uncertainties may ensue. Other emotional responses may become more pronounced as the adult burn survivor comes to terms with the injury and the losses associated with it. Thus, the adult burn survivor transitions to the early post-discharge period with several physical, psychological, and social needs whilst at the same time, they are expected to assume full responsibility for their care. By 3 months post-discharge, burn survivors experience increasing psychological burden, poor physical role performances and poor quality of life. Within 6 months to 1 year post-discharge without professional support, the adult burn patient may experience further emotional distress reflected by the high rates of depression, sleep disturbance, body image concerns and sexual problems. Although statistically insignificant, several studies have reported an improvement in burn-specific health beyond 1year post-burn. Besides, psychosocial distress may still persist by 9 years post-discharge. These strengthen the need for ongoing comprehensive and continuous care to facilitate early identification and resolution of biopsychosocial needs that may emerge; a care pathway similar to persons living with chronic conditions.
Along the recovery trajectory for adult burn survivors, findings from several studies suggest that the greatest physical and psychosocial decline may be experienced by 2-3 months post-discharge. This assertion implies that the discharge to early post-discharge period, that is, 2 months following discharge represent a vulnerable period which can impact adversely on the long-term recovery outcomes of adult burn survivors. The period has been described as unpredictable with the emergence of varied needs requiring an individualized approach to care on regular basis than is provided by interval outpatient clinic visits. Despite these assertions, it is around this period that professional support may be limited or unavailable and some adult burn survivors may not return to the hospital due to issues such as long travel distances and associated costs. These raise an interest regarding how professional support can be organized and delivered as the patient transitions to the early post-discharge period in the home or community to ensure that they receive the sustained and comprehensive rehabilitative support. Thus, the current study to develop a nurse-led transitional rehabilitation programme and evaluate its effects among adult burn survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomised to either the control or intervention groups with the former receiving the existing care at the hospital and the latter receiving the both the new intervention and existing standard of care.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)The 4C's-TBuRP for adult burn survivors comprises of two phases: * Phase 1: Discharge planning/ preparation and day of discharge (Comprehensive assessment and evaluation, Education, guidance, and counselling, Treatment and procedures, Case management (referral for nursing follow-up), multi-disciplinary follow-up and Surveillance) * Phase 2: Follow-up Phase (2 WeChat Telehealth, 6 structured telephone follow-ups and daytime patient/ family-initiated telephone service; home visit based on meeting criteria) over an 8-week follow-up with delivery of rehabilitation care across the spectrum by trained nurse case managers ongoing assessment, intervention using the Omaha System and delivery of evidence-based care. |
| Control group | Active comparator | Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)Participants in the control group will receive the care at the discharge planning phase and thereafter continue to utilise the exiting service available at the hospital, that is, medical review in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Burn size ≥10% TBSA
- Reachable on phone and WeChat
- Absence of confirmed psychiatric condition
- Absence of confirmed chronic diagnosis of renal failure or diabetes mellitus with foot ulcers
Key exclusion criteria (1 listed)
- Unable to communicate Not reachable via phone Confirmed underlying psychiatry or renal failure or diabetes mellitus with foot ulcers Already engaged in another burn rehabilitation programme Will not reside in the specified location within three months of recruitment
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 |
|---|---|---|
| Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)The nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) is presented as an 8-week interventional programme that supports holistic care for adult burn survivors led by a specialist burn care nurse and supported by the burn care team. The intervention posits that as the adult burn survivor transitions, several physiological, psychosocial, health-related behaviour and environmental needs emerge which lead to poor quality of life. Despite this, they may be unable to return to utilise available healthcare services or have inadequate contact with rehabilitation services. To facilitate their recovery and enhance the attainment of rehabilitation outcomes, the 4Cs-TBuRP views the burn care nurse as the link between rehabilitation services and the adult burn survivor. Thus, the burn care nurse serves as the coordinator of care and actively collaborates with the burn care team and the patient/ family to ensure that continuous care is delivered in a timely manner. | Other | Control group, Treatment group |
Primary outcome
Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D.
Time frame: Three months
The Burn Specific Health Scale-Brief comprises of 40 questions, 9 sub-scales, and 3 domains (physical, mental, and social). Each item is scored on a 5-point scale ranging from 0 (extremely) to 4 (not at all). The maximum score is 140. Lower scores suggest poor quality of life and higher scores imply good quality of life. Internal consistency of the total instrument has been reported to be α=0.94 with test-retest reliability suggesting that the Intraclass Correlation Coefficient (ICC) ranged from 0.81 to 0.96 with a total score of 0.93. The 5-level EQ-5D has five response levels: level 1 (no problem) to level 5 (extreme problem). The possible health states are defined by combining one level from each dimension. An EQ-5D-5L index value is calculated ranging from 0 (death) to 1 (full health). Decreasing scores therefore suggest poor health whilst increasing scores suggest good health.
5 secondary outcomes
Chinese version of the Hospital Anxiety and Depression Scale
Time frame: Three months
Chinese version of the Pittsburgh Sleep Quality Index
Time frame: Three months
Chinese version of the Brief Pain Inventory
Time frame: Three months
Chinese version of a visual analogue scale
Time frame: Three months
Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH)
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- BackgroundAlbarran, J. (2005). Response to editorial: Nurse led care. British Medical Journal (BMJ), 330, 682-683.
- Background: PubMed 20958968Brusselaers N, Monstrey S, Vogelaers D, Hoste E, Blot S. Severe burn injury in Europe: a systematic review of the incidence, etiology, morbidity, and mortality. Crit Care. 2010;14(5):R188. doi: 10.1186/cc9300. Epub 2010 Oct 19.
- Background: PubMed 27574666Chinese Burn Association; Chinese Association of Burn Surgeons; Cen Y, Chai J, Chen H, Chen J, Guo G, Han C, Hu D, Huan J, Huang X, Jia C, Li-Tsang CW, Li J, Li Z, Liu Q, Liu Y, Luo G, Lv G, Niu X, Peng D, Peng Y, Qi H, Qi S, Sheng Z, Tang D, Wang Y, Wu J, Xia Z, Xie W, Yang H, Yi X, Yu L, Zhang G; Chinese Burn Care and Rehabilitation Association. Guidelines for burn rehabilitation in China. Burns Trauma. 2015 Oct 21;3:20. doi: 10.1186/s41038-015-0019-3. eCollection 2015.
- Background: PubMed 26231290Christiaens W, Van de Walle E, Devresse S, Van Halewyck D, Benahmed N, Paulus D, Van den Heede K. The view of severely burned patients and healthcare professionals on the blind spots in the aftercare process: a qualitative study. BMC Health Serv Res. 2015 Aug 1;15:302. doi: 10.1186/s12913-015-0973-2.
- Background: PubMed 20629737Evers LH, Bhavsar D, Mailander P. The biology of burn injury. Exp Dermatol. 2010 Sep;19(9):777-83. doi: 10.1111/j.1600-0625.2010.01105.x. Epub 2010 Jul 14.
- Background: PubMed 31203869Gerber LH, Bush H, Holavanahalli R, Esselman P, Schneider J, Heinemann A, Garfinkel S, Cai C. A scoping review of burn rehabilitation publications incorporating functional outcomes. Burns. 2019 Aug;45(5):1005-1013. doi: 10.1016/j.burns.2018.09.029. Epub 2018 Oct 26.
- Background: PubMed 25144806Gullick JG, Taggart SB, Johnston RA, Ko N. The trauma bubble: patient and family experience of serious burn injury. J Burn Care Res. 2014 Nov-Dec;35(6):e413-27. doi: 10.1097/BCR.0000000000000030.
- Background: PubMed 28888298Hundeshagen G, Suman OE, Branski LK. Rehabilitation in the Acute Versus Outpatient Setting. Clin Plast Surg. 2017 Oct;44(4):729-735. doi: 10.1016/j.cps.2017.05.004. Epub 2017 Jul 28.
- Background: PubMed 29290511Jagnoor J, Lukaszyk C, Fraser S, Chamania S, Harvey LA, Potokar T, Ivers RQ. Rehabilitation practices for burn survivors in low and middle income countries: A literature review. Burns. 2018 Aug;44(5):1052-1064. doi: 10.1016/j.burns.2017.10.007. Epub 2017 Dec 28.
- Background: PubMed 29207887Kornhaber R, Rickard G, McLean L, Wiechula R, Lopez V, Cleary M. Burn care and rehabilitation in Australia: health professionals' perspectives. Disabil Rehabil. 2019 Mar;41(6):714-719. doi: 10.1080/09638288.2017.1406009. Epub 2017 Dec 5.
- Background: PubMed 29977882Lotfi M, Ghahremaneian A, Aghazadeh A, Jamshidi F. The Effect of Pre-Discharge Training on the Quality of Life of Burn Patients. J Caring Sci. 2018 Jun 1;7(2):107-112. doi: 10.15171/jcs.2018.017. eCollection 2018 Jun.
- Background: PubMed 29395409McAleavey AA, Wyka K, Peskin M, Difede J. Physical, functional, and psychosocial recovery from burn injury are related and their relationship changes over time: A Burn Model System study. Burns. 2018 Jun;44(4):793-799. doi: 10.1016/j.burns.2017.12.011. Epub 2018 Feb 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP) in people with Burns Multiple, run by The Hong Kong Polytechnic University at 1 site in China.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Simplified Chinese versions of Burn Specific Health Scale-Brief and the 5-level EQ-5D. (time frame: Three months). 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 NCT04517721, which also lists 50 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 21 Jun 2022.