Smartphone Assisted Self-management Education for Adult Burn Patient At Aftercare

NCT06263296 | Recruiting DMC

• 1 other identifier: UW 24-055
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care. The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report:

1. 1.Higher level of health-related quality of life,
2. 2.Higher level of self-efficacy
3. 3.Higher level of score in Burn Rehabilitation Knowledge
4. 4.Lower pain level, as measured by Numeric Pain Rating Scale; and
5. 5.Lower level of itchiness

Conditions

Burns; Self Efficacy; Burn Second Degree; Burns Third Degree; Quality of Life; Adherence, Treatment; Burn Injury

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12

  Burn Specific Health Scale-Brief (BSHS-B) Taiwanese version (40-items, Appendix 7) will be used to quantify the recovery of quality of life (QoL) among burn survivor in general, physical, mental, and social health aspects. Responses are measured on a 5-point scale ranging from 0 ("extreme") to 4 ("none at all"). The total (BSHS-B score is the sum of the subscale scores (range: 0-160), with a higher score indicating better quality of life post burn injury.

  Baseline and Week 4; Week 12

• Change from Baseline in the Generic Quality of life at Week 4 & Week 12

  5Q-5D-5L Hong Kong- Traditional Chinese version (Appendix 8) ls used to measure the generic health-related quality of life (HRQoL) among subjects. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The digits for the five dimensions can be combined in a 5-digit code that describes the respondent's health state.

  Baseline and Week 4; Week 12

• Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire

  The Burn Rehabilitation Knowledge Questionnaire is developed by the principal investigator after reviewing the relevant and recent international scientific literature to identify patients' learning needs and essential concept in facilitating burn rehabilitation. This questionnaire consisted of twenty-four multiple choice questions covering three well-defined areas: general knowledge about burns (8 items), rehabilitation modalities (8 items), and burns related healthy lifestyle modifications (8 items). The total scores were computed out of (24 grades). A higher score indicated better knowledge in burn rehabilitation.

  Baseline and Week 4

Secondary Outcomes (3)

• Change from Baseline in the Self efficacy at Week 4 & Week 12

  Baseline and Week 4; Week 12

• Change from Baseline in the Itchiness of life at Week 4 & Week 12

  Baseline and Week 4; Week 12

• Change from Baseline in the Pain level at Week 4 & Week 12

  Baseline and Week 4; Week 12

Other Outcomes (1)

• Percentage in the Burn related out-patient clinic attendance

  Week 4; Week 12

Study Arms (2)

Interventional Group

EXPERIMENTAL

For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well.

Behavioral: Self Management Education

Control Group

NO INTERVENTION

For control group, participants will receive usual care by ward nurses (provide burn discharge pamphlet upon discharge + regular plastic surgeon follow up)

Interventions

Self Management Education BEHAVIORAL

Smartphone assisted self management education incorporated with the concept of motivational interviewing

Interventional Group

Eligibility Criteria

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

You may qualify if:

• Chinese adult aged above 18 years old
• Hospitalized burn patient
• Adult who can understand Cantonese
• Superficial partial thickness burn: TBSA \>10%
• Deep partial thickness burn or full thickness burn: TBSA \> 5%

You may not qualify if:

• Inhalation injury solely
• Sustained burn injury due to self-injury
• Diagnosed psychiatric illness with or without medication
• Client who is unable to communicate via instant messaging apps

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

LIU Siu Kwong

Hong Kong, China

RECRUITING

Related Publications (5)

• Procter F. Rehabilitation of the burn patient. Indian J Plast Surg. 2010 Sep;43(Suppl):S101-13. doi: 10.4103/0970-0358.70730.

  PMID: 21321643 BACKGROUND

• Spronk I, Legemate C, Oen I, van Loey N, Polinder S, van Baar M. Health related quality of life in adults after burn injuries: A systematic review. PLoS One. 2018 May 24;13(5):e0197507. doi: 10.1371/journal.pone.0197507. eCollection 2018.

  PMID: 29795616 BACKGROUND

• Esselman PC. Burn rehabilitation: an overview. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S3-6. doi: 10.1016/j.apmr.2007.09.020.

  PMID: 18036978 BACKGROUND

• Smolle C, Cambiaso-Daniel J, Forbes AA, Wurzer P, Hundeshagen G, Branski LK, Huss F, Kamolz LP. Recent trends in burn epidemiology worldwide: A systematic review. Burns. 2017 Mar;43(2):249-257. doi: 10.1016/j.burns.2016.08.013. Epub 2016 Sep 3.

  PMID: 27600982 BACKGROUND

• Barrett LW, Fear VS, Waithman JC, Wood FM, Fear MW. Understanding acute burn injury as a chronic disease. Burns Trauma. 2019 Sep 16;7:23. doi: 10.1186/s41038-019-0163-2. eCollection 2019.

  PMID: 31534977 BACKGROUND

MeSH Terms

Conditions

Burns; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Wounds and Injuries; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only subject will be single blinded to the intervention provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Nurse Consultant, Department of Surgery, Principal Investigator

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: February 10, 2024
• Primary Completion: August 28, 2025
• Study Completion: December 30, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-05

Locations

CN (1)