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

October 15, 2024 updated by: Liu Siu Kwong, Queen Mary Hospital, Hong Kong

The Impact on Quality of Life in Individual with Burn Injury: Utilizing Smartphone Assisted Self-management Education At Aftercare

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

The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.

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. Ad-hoc instant messaging support will be provided to both groups if required.

Study Overview

Detailed Description

Due to the advancement of medical treatment, burn-related mortality has been reduced especially in developed countries . Long-term undesirable impacts such as wound problems, skin care, exercise training, scar management, psychological and social problems have been detected in both major and non-major burns (less than 20% total body surface area (TBSA). The focus of burn care is shifted not only acute care but also rehabilitation.

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

The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period.

Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care.

After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps.

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. Ad-hoc instant messaging support will be provided to both groups if required.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, China
        • Recruiting
        • LIU Siu Kwong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
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.
Smartphone assisted self management education incorporated with the concept of motivational interviewing
No Intervention: Control Group
For control group, participants will receive usual care by ward nurses (provide burn discharge pamphlet upon discharge + regular plastic surgeon follow up)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12
Time Frame: Baseline and 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
Time Frame: Baseline and 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
Time Frame: Baseline and Week 4
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Self efficacy at Week 4 & Week 12
Time Frame: Baseline and Week 4; Week 12
Chinese Adaptation of the General Self-Efficacy Scale (C-GSE, 10 items, Appendix 9) will be used to measure the sense of self efficacy of the patients. The General Self-Efficacy Scale is correlated to emotion, optimism, work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout, and anxiety. Responses are measured on a 4-point scale ranging from 1 ("Not at all") to 4 ("Exactly True"). The total GSE score is the sum of the subscale scores (range: 10-40), with a higher score indicating more self-efficacy.
Baseline and Week 4; Week 12
Change from Baseline in the Itchiness of life at Week 4 & Week 12
Time Frame: Baseline and Week 4; Week 12
5D itch score(5D-IS)- Chinese version (Appendix 10) will be used to measure severity of itchiness in five dimensions which are degree, duration, direction, disability and distribution. the first four domains were measured on a five-point Likert scale. The distribution domain included 16 potential locations of itch, the more itchy area, the higher score will be obtained in this domain. Responses are measured on a 5-point scale ranging from 1 to 5 ranged between 5 (no pruritus) and 25 (most severe pruritus).
Baseline and Week 4; Week 12
Change from Baseline in the Pain level at Week 4 & Week 12
Time Frame: Baseline and Week 4; Week 12
Numeric Pain Rating Scale (NPRS) will be used to measure the subjective intensity of pain. Responses are measured on a 11-point scale ranging from 0 ("no pain") to 10 ("the most intense pain imaginable").
Baseline and Week 4; Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage in the Burn related out-patient clinic attendance
Time Frame: Week 4; Week 12
Burn related out-patient clinic attendance including doctor, nurse, allied health after discharge will be traced back within three months.
Week 4; Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Estimated)

August 28, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-055

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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