Diabetic Foot Ulcer
Conditions
Keywords
short message, wound healing, diabetic foot ulcer
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.
Interventions
BEHAVIORALcustomized 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are assigned to two groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whether the Wound Shrinks | baseline and after four, eight weeks | In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk. |
| Diabetes-related Foot Ulcer Quality of Life | Baseline and after four, eight weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-related Foot Ulcer Self-management Behavior | Baseline and after four, eight weeks | 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. |
| Diabtes-related Foot Ulcer Self-management Self-efficacy | Baseline and after four, eight weeks | 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. |
| Diabetes Self-care Behaviors | Baseline and after four, 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 total SDSCA score ranges 1-63. |
| Diabetes-related Foot Self-care Behavior | Baseline and after four, 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Comparison Routine care | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Comparison | Total |
|---|---|---|---|
| Age, Continuous | 50.88 years STANDARD_DEVIATION 9.8 | 60.0 years STANDARD_DEVIATION 9.61 | 55.29 years STANDARD_DEVIATION 10.69 |
| Quality of life | 18.5 units on a scale | 21.0 units on a scale | 19.0 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Taiwan | 16 participants | 15 participants | 31 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
| The wound area | 4.5013 cm2 STANDARD_DEVIATION 6.49684 | 3.8820 cm2 STANDARD_DEVIATION 5.05084 | 4.4342 cm2 STANDARD_DEVIATION 5.69722 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
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.
Time frame: Baseline and after four, eight weeks
Population: One participants lost follow-up at four weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Diabetes-related Foot Ulcer Quality of Life | QoL at four weeks | 15.5 score on a scale |
| Intervention | Diabetes-related Foot Ulcer Quality of Life | QoL at eight weeks | 12.50 score on a scale |
| Comparison | Diabetes-related Foot Ulcer Quality of Life | QoL at four weeks | 16.5 score on a scale |
| Comparison | Diabetes-related Foot Ulcer Quality of Life | QoL at eight weeks | 15.00 score on a scale |
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.
Time frame: baseline and after four, eight weeks
Population: One participant was lost at four weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Whether the Wound Shrinks | wound shrinks at four weeks | 10 Participants |
| Intervention | Whether the Wound Shrinks | wound shrink at eight weeks | 11 Participants |
| Comparison | Whether the Wound Shrinks | wound shrinks at four weeks | 12 Participants |
| Comparison | Whether the Wound Shrinks | wound shrink at eight weeks | 14 Participants |
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.
Time frame: Baseline and after four, eight weeks
Population: One participant lost at four weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Diabetes-related Foot Self-care Behavior | Diabetes-related foot self-care behavior at four weeks | 22.0 score on a scale |
| Intervention | Diabetes-related Foot Self-care Behavior | Diabetes-related foot self-care behavior at eight weeks | 22.0 score on a scale |
| Comparison | Diabetes-related Foot Self-care Behavior | Diabetes-related foot self-care behavior at four weeks | 23.0 score on a scale |
| Comparison | Diabetes-related Foot Self-care Behavior | Diabetes-related foot self-care behavior at eight weeks | 22.50 score on a scale |
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.
Time frame: Baseline and after four, eight weeks
Population: One participant lost at four weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Diabetes-related Foot Ulcer Self-management Behavior | DFU self-management behavior at four weeks | 33 score on a scale |
| Intervention | Diabetes-related Foot Ulcer Self-management Behavior | DFU self-management behavior at eight weeks | 34 score on a scale |
| Comparison | Diabetes-related Foot Ulcer Self-management Behavior | DFU self-management behavior at four weeks | 34 score on a scale |
| Comparison | Diabetes-related Foot Ulcer Self-management Behavior | DFU self-management behavior at eight weeks | 34 score on a scale |
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.
Time frame: Baseline and after four, eight weeks
Population: One participant lost at four weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Diabetes Self-care Behaviors | SDSCA at four weeks | 37.0 score on a scale |
| Intervention | Diabetes Self-care Behaviors | SDSCA at eight weeks | 35.50 score on a scale |
| Comparison | Diabetes Self-care Behaviors | SDSCA at four weeks | 35.0 score on a scale |
| Comparison | Diabetes Self-care Behaviors | SDSCA at eight weeks | 35.0 score on a scale |
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.
Time frame: Baseline and after four, eight weeks
Population: One participant lost at four weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Diabtes-related Foot Ulcer Self-management Self-efficacy | self-management self-efficacy at four weeks | 97.5 score on a scale |
| Intervention | Diabtes-related Foot Ulcer Self-management Self-efficacy | self-management self-efficacy at eight weeks | 98.5 score on a scale |
| Comparison | Diabtes-related Foot Ulcer Self-management Self-efficacy | self-management self-efficacy at four weeks | 95.0 score on a scale |
| Comparison | Diabtes-related Foot Ulcer Self-management Self-efficacy | self-management self-efficacy at eight weeks | 98.0 score on a scale |