The Short Message-based Customized Standardized

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06037369

Collaborator

(none)

178

Enrollment

Location

Arms

34.5

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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. 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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Behavioral: customized standardized educational program sent by LINE software.	N/A

Detailed Description

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.

In the first year, a customized standardized patient education program will be developed, and then the effectiveness evaluation will be carried out. A randomized controlled study design will be adopted, and 178 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 generalized estimating equation (GEE) will be used to evaluate the effectiveness of the intervention.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to two groups in parallel for the duration of the studyParticipants are assigned to two groups in parallel for the duration of the study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Sep 14, 2023

Anticipated Primary Completion Date :

Jul 30, 2026

Anticipated Study Completion Date :

Jul 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object	Behavioral: customized standardized educational program sent by LINE software. At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object.
No Intervention: comparison Routine care

Arm

Intervention/Treatment

Experimental: intervention

At each visit of the research subjects to plastic clinic, the research team record the attending prescriptions and patient educations given by the medical team members, and evaluate whether the research subjects and caregivers need additional mental support or not. Then, according to the above evaluation and records, items of a designed patient education menu will be selected, and the selected patient education messages will be sent according to the transmission frequency and time period proposed by the research object

Behavioral: customized standardized educational program sent by LINE software.

No Intervention: comparison

Routine care

Outcome Measures

Primary Outcome Measures

Wound healing [baseline and after four and eight weeks]
In this study, whether the percentage foot ulcer area reduction (PAR) reaches 50% after four weeks and whether DFU is healed is used as the evaluation index. We used the following formula to calculate the percentage area reduction (PAR): PAR = (primary wound area - secondary area / primary area) × 100
DFU Quality of life [Baseline and after four and eight weeks]
Questionnaire on quality of life with chronic wounds (Wound QoL-17) will be used at four weeks and eight weeks after baseline to evaluate the change of QOL. Questionnaire on quality of life with chronic wound (Wound-QoL) has 17 items to measure the quality of life of patients with chronic wounds. Using the 5-point Likert scale, the patients were asked to report their chronic wounds in the past seven days, ranging from 0 (not at all) to 4 (very affected), with higher average scores indicating poorer quality of life. The total DFUSMB score ranges 0-68.

Secondary Outcome Measures

DFU self-management behavior [Baseline and after four and eight weeks]
In this study, "DFU Self-Management Behavior Scale" (DFUSMB), will be used to measure DFU self-management behavior at four weeks and eight weeks after baseline. The DFUSMB measures behaviors that promote wound healing and prevent wound deterioration with 18 items in total, using the five-point Likert scale. "Never", "Seldom", "Sometimes", "Often" and "Always" are scored from 1 to 5 respectively. Reverse questions are scored in reverse, and the higher the total score, the better the self-management behavior of DFUs. The total DFUSMB score ranges 18-90.The DFUSMB has sufficient reliability and validity.
DFU self-management self-efficacy [Baseline and after four and eight weeks]
The researcher developed the Diabetic Foot Ulcer Self-Efficacy Scale (DFUMSE) consisting of 17 self-constructed questions to measure self-efficacy in diabetic foot ulcer management. A scoring system of 0 to 10 points is used, where 0 points indicate no confidence at all, and 10 points indicate complete confidence. Higher scores indicate higher self-efficacy. The total DFUMSE score ranges 0-170. Two questions were used to measure self-efficacy for foot self-care: "I am confident that I can: Check the soles and toe gaps of my feet every day by myself (or with someone's assistance)." "I am confident that I can: Apply lotion or Vaseline to my feet every day by myself (or with someone's assistance) when the skin on my feet is dry." Both questions were scored using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy.
Diabetes self-care behaviors [Baseline and after four and eight weeks]
The summary of diabetes self-care activity questionnaire (SDSCA) In this study, the summary of diabetes self-care activity questionnaire (SDSCA) will be used. The SDSCA questionnaire was developed by Deborah Toobert. It focuses on general diet, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. The instrument assesses the absolute frequency or consistency of ten diabetes health-related regimen behaviors (e.g., number of days per week on which respondents engage in physical activity sessions; number of days in past 7 days respondents ate five or more servings of fruits and vegetables). Reverse questions are scored in reverse, and the higher the total score, the better the diabetes self-care activity. The eleventh question asks whether there is smoking, and if so, it is counted as 1 point. The total SDSCA score ranges 1-71.
Diabetes-related foot self-care behavior [Baseline and after four and eight weeks]
In this study, "Diabetic Foot Self-Care Behavior Scale" (DFSBS) will be used to measure diabetes-related foot self-care behavior at four weeks and eight weeks after baseline. The DFSBS has 7 questions, asking the participants how often they perform foot care behaviors. The total DFSBS score ranges 7-35. The higher the score, the better the foot care behavior. The DFSBS has sufficient reliability and validity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.