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The Short Message-based Customized Standardized

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
customized standardized educational program sent by LINE software.
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Foot Ulcer focused on measuring short message, wound healing, diabetic foot ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

comparison

Arm Description

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

Routine care

Outcomes

Primary Outcome Measures

Wound healing
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
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
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
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
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
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.

Full Information

First Posted
August 29, 2023
Last Updated
September 18, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06037369
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
short message, wound healing, diabetic foot ulcer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to two groups in parallel for the duration of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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
Arm Title
comparison
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Behavioral
Intervention Name(s)
customized standardized educational program sent by LINE software.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing
Description
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
Time Frame
baseline and after four and eight weeks
Title
DFU Quality of life
Description
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.
Time Frame
Baseline and after four and eight weeks
Secondary Outcome Measure Information:
Title
DFU self-management behavior
Description
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.
Time Frame
Baseline and after four and eight weeks
Title
DFU self-management self-efficacy
Description
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.
Time Frame
Baseline and after four and eight weeks
Title
Diabetes self-care behaviors
Description
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.
Time Frame
Baseline and after four and eight weeks
Title
Diabetes-related foot self-care behavior
Description
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.
Time Frame
Baseline and after four and eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yenfan Chin
Phone
032118800
Ext
5189
Email
yenfan@mail.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yenfan Chin
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yenfan Chin, PhD
Phone
886-3-2118800
Ext
5189
Email
yenfan@mail.cgu.edu.tw

12. IPD Sharing Statement

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The Short Message-based Customized Standardized

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