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| ID | Type | Description | Link |
|---|---|---|---|
| NSTC112-2314-B-182-028 | Other Grant/Funding Number | National Science and Technology Council |
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Due to lack of funds and the lack of significant results from the pilot test, we terminated the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | 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 |
|
| comparison | No Intervention | Routine care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| customized standardized educational program sent by LINE software. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Whether the Wound Shrinks | In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk. | baseline and after four, eight weeks |
| Diabetes-related Foot Ulcer Quality of Life | Questionnaire on quality of life with chronic wounds (Wound QoL-14) 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 14 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 range of scores is 0 to 56. | Baseline and after four, eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes-related Foot Ulcer Self-management Behavior | In this study, "Diabetes-related Foot Ulcer 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. In this study, we only collected the wound management subscale scores. The 7-item subscale score ranges 7-35. The DFUSMB has sufficient reliability and validity. |
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The inclusion criteria are:
The exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Yenfan Chin | Chang Gung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan City | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 | Comparison | Routine care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whether the Wound Shrinks | In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk. | One participant was lost at four weeks | Posted | Count of Participants | Participants | baseline and after four, eight weeks |
|
4, 8 weeks
The number of participants at risk for Serious Adverse Events is 31. The number of participants at risk for All-Cause Mortality is 31. The number of participants at risk for Other (Not Including Serious) Adverse Events is 31.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yen-Fan Chin | Chang Gung University, Taiwan | 032118800 | 5189 | yenfan@mail.cgu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2023 | Dec 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Participants are assigned to two groups in parallel for the duration of the study
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|
| Baseline and after four, eight weeks |
| Diabtes-related Foot Ulcer Self-management Self-efficacy | We used 11 questions to measure the diabtes-related foot ulcer self-management self-efficacy, using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy. The sum score of the above 11 items indicates the DFU self-management self-efficacy with range from 0 to 110. | Baseline and after four, eight weeks |
| 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 total SDSCA score ranges 1-63. | Baseline and after four, eight weeks |
| 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. | Baseline and after four, eight weeks |
| BG001 | Comparison | Routine care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The wound area | Wound size is calculated by multiplying the length of the longest part of the wound by its vertical The longest width in the direction. For irregular-shaped areas, take pictures and use image statistics software to calculate the area. Wound meter measurements to assess subsequent changes | Mean | Standard Deviation | cm2 |
|
| Quality of life | Measuring quality of life with the Wound QoL-14. This is the pretest data | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Comparison | Routine care |
|
|
| Primary | Diabetes-related Foot Ulcer Quality of Life | Questionnaire on quality of life with chronic wounds (Wound QoL-14) 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 14 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 range of scores is 0 to 56. | One participants lost follow-up at four weeks | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and after four, eight weeks |
|
|
|
| Secondary | Diabetes-related Foot Ulcer Self-management Behavior | In this study, "Diabetes-related Foot Ulcer 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. In this study, we only collected the wound management subscale scores. The 7-item subscale score ranges 7-35. The DFUSMB has sufficient reliability and validity. | One participant lost at four weeks | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and after four, eight weeks |
|
|
|
| Secondary | Diabtes-related Foot Ulcer Self-management Self-efficacy | We used 11 questions to measure the diabtes-related foot ulcer self-management self-efficacy, using an 11-point scale, with 0 indicating no confidence at all and 10 indicating complete confidence. Higher scores reflect higher self-efficacy. The sum score of the above 11 items indicates the DFU self-management self-efficacy with range from 0 to 110. | One participant lost at four weeks. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and after four, eight weeks |
|
|
|
| Secondary | 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 total SDSCA score ranges 1-63. | One participant lost at four weeks. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and after four, eight weeks |
|
|
|
| Secondary | 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. | One participant lost at four weeks. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and after four, eight weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Comparison | Routine care | 0 | 15 | 0 | 15 | 0 | 15 |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |