跳至主要内容
临床试验/NCT06263296
NCT06263296招募中不适用

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

Queen Mary Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Change from Baseline in the Disease Specific Quality of life at Week 4 & Week 12

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Only subject will be single blinded to the intervention provided

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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%

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

Change from Baseline in the Burn Rehabilitation Knowledge Questionnaire

时间窗: 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.

次要结局

  • Change from Baseline in the Itchiness of life at Week 4 & Week 12(Baseline and Week 4; Week 12)
  • Change from Baseline in the Self efficacy 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)

研究者

发起方
Queen Mary Hospital, Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Siu Kwong

Associate Nurse Consultant, Department of Surgery, Principal Investigator

Queen Mary Hospital, Hong Kong

研究点 (1)

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