Clinical trial NCT06037369: The Short Message-based Customized Standardized
Official title: The Effectiveness of a Short Message-based Customized Standardized Education Program in Promoting Wound Healing and Quality of Life of Patients With Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: short message
wound healing
diabetic foot ulcer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.

A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.

Detailed description: The diabetic foot ulcer need complex treatment, and is with poor prognosis, thus it consumes medical resources and impedes the quality of life of patients. Most of the time, patients are required to perform diabetic foot ulcer self-management at home. However, their self-management behaviors are inadequate.

Individualized patient education message can promote and maintain appropriate diabetes self-management behaviors of patients. The short message-based customized standardized patient education program combines several smartphone message-based standardized educational contents to construct a customized patient education program which is according to the needs of patients, thus providing individualized patient education in a timely manner. The short message-based customized standardized patient education program may improve the diabetic foot ulcers self-management behavior and the self-efficacy on diabetic foot ulcers self-management, thereby promoting wound healing and improving quality of life.

The purpose of this study is to develop a short message-based customized standardized diabetic foot ulcer patient education program, and to test the effect of the program on diabetic foot ulcer self-management behavior, self-efficacy, wound prognosis, and quality of life.

The innovation of this study are as follows：our intervention is the first program in the world that (1) provides timely and individualized patient education in a customized standardized way, and (2) provides short message-based patient education for prevention and treatment of diabetic foot ulcers.

A customized standardized patient education module will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and more than 30 outpatients with diabetic foot ulcers are expected to be recruited. The control group will receive routine care, while the experimental group will receive a short message-based customized standardized diabetic foot ulcer patient education program after their outpatient visits. Subjects will be followed up for eight weeks, and the Mann-Whitney U test and Fisher's correct probability test will be used to evaluate the effectiveness of the intervention.

Eligibility criteria: The inclusion criteria are:

* Outpatients with foot ulcers
* Diagnosed as diabetic patients
* Can be interviewed in Mandarin or Taiwanese.

The exclusion criteria are:

* It is expected that there is no need to return to the clinic at the eighth week after the baseline, or the number of return visits within eight weeks will be less than two times
* Patient and family members living with him/her do not use a smart phone
* Being unable to read text messages on mobile phone, or with impaired hearing, could not answer the phone
* Impaired fine hand movements, unable to click on mobile phone text messages
* Unwilling to use the communication software LINE to receive text messages.

Primary outcomes:
measure: Whether the Wound Shrinks
timeFrame: baseline and after four, eight weeks
measure: Diabetes-related Foot Ulcer Quality of Life
timeFrame: Baseline and after four, eight weeks
Secondary outcomes:
measure: Diabetes-related Foot Ulcer Self-management Behavior
timeFrame: Baseline and after four, eight weeks
measure: Diabtes-related Foot Ulcer Self-management Self-efficacy
timeFrame: Baseline and after four, eight weeks
measure: Diabetes Self-care Behaviors
timeFrame: Baseline and after four, eight weeks
measure: Diabetes-related Foot Self-care Behavior
timeFrame: Baseline and after four, eight weeks
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Yenfan Chin
role: PRINCIPAL_INVESTIGATOR
References: