Effects of a Nurse-led Transitional Burns Rehabilitation Programme

NCT04517721 | Completed

• 1 other identifier: HSEARS20200730001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Burns Multiple

Outcome Measures

Primary Outcomes (1)

• 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.

  Three months

Secondary Outcomes (5)

• Chinese version of the Hospital Anxiety and Depression Scale

  Three months

• Chinese version of the Pittsburgh Sleep Quality Index

  Three months

• Chinese version of the Brief Pain Inventory

  Three months

• Chinese version of a visual analogue scale

  Three months

• Chinese version of the Disability of the Arm, Shoulder and Hand Symptom Scale (DASH)

  Three months

Study Arms (2)

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.

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.

Other: Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)

Interventions

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.

Control group; Treatment group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Gansu Provincial Hospital

Gansu, Lanzhou, 076, China

Location

Related Publications (50)

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  PMID: 39529032 DERIVED

• Bayuo J, Wong FKY, Chung LYF. Effect of a transitional tele-rehabilitation programme on quality of life of adult burn survivors: A randomised controlled trial. Clin Rehabil. 2024 Oct;38(10):1333-1345. doi: 10.1177/02692155241265930. Epub 2024 Aug 27.

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• Bayuo J, Wong FKY, Chung LYF. Effects of a nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) for adult burn survivors: protocol for a randomised controlled trial. Trials. 2021 Oct 13;22(1):698. doi: 10.1186/s13063-021-05679-7.

  PMID: 34645512 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will receive same care at the pre-discharge phase. However in the post-discharge phase where participants are not likely to interact with each other, persons in the control group will continue to receive the usual care whilst persons in the treatment group receives the new intervention. The assigned group of participants will not be disclosed to the outcome assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: December 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)