Trial Outcomes & Findings for The Short Message-based Customized Standardized (NCT NCT06037369)

NCT ID: NCT06037369

Last Updated: 2025-01-08

Results Overview

In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: baseline and after four, eight weeks
• Results posted on: 2025-01-08

Participant Flow

Participant milestones

Measure	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.	Comparison Routine care
Overall Study STARTED	16	15
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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.	Comparison Routine care
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=16 Participants 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.	Comparison n=15 Participants Routine care	Total n=31 Participants Total of all reporting groups
Age, Continuous	50.88 years STANDARD_DEVIATION 9.80 • n=16 Participants	60.0 years STANDARD_DEVIATION 9.61 • n=15 Participants	55.29 years STANDARD_DEVIATION 10.69 • n=31 Participants
Sex: Female, Male Female	5 Participants n=16 Participants	4 Participants n=15 Participants	9 Participants n=31 Participants
Sex: Female, Male Male	11 Participants n=16 Participants	11 Participants n=15 Participants	22 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Taiwan	16 participants n=16 Participants	15 participants n=15 Participants	31 participants n=31 Participants
The wound area	4.5013 cm2 STANDARD_DEVIATION 6.49684 • n=16 Participants	3.8820 cm2 STANDARD_DEVIATION 5.05084 • n=15 Participants	4.4342 cm2 STANDARD_DEVIATION 5.69722 • n=31 Participants
Quality of life	18.5 units on a scale n=16 Participants	21.0 units on a scale n=15 Participants	19.0 units on a scale n=31 Participants

PRIMARY outcome

Timeframe: baseline and after four, eight weeks

Population: One participant was lost at four weeks

In this study, Subtract the pre-measurement area from the post-measurement area to assess whether the wound has shrunk.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Whether the Wound Shrinks wound shrinks at four weeks	10 Participants	12 Participants
Whether the Wound Shrinks wound shrink at eight weeks	11 Participants	14 Participants

PRIMARY outcome

Timeframe: Baseline and after four, eight weeks

Population: One participants lost follow-up at four 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.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Diabetes-related Foot Ulcer Quality of Life QoL at four weeks	15.5 score on a scale Interval 13.0 to 22.25	16.5 score on a scale Interval 14.75 to 30.5
Diabetes-related Foot Ulcer Quality of Life QoL at eight weeks	12.50 score on a scale Interval 9.5 to 16.0	15.00 score on a scale Interval 10.5 to 28.25

SECONDARY outcome

Timeframe: Baseline and after four, eight weeks

Population: One participant lost at four 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.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Diabetes-related Foot Ulcer Self-management Behavior DFU self-management behavior at four weeks	33 score on a scale Interval 31.0 to 34.0	34 score on a scale Interval 32.0 to 34.25
Diabetes-related Foot Ulcer Self-management Behavior DFU self-management behavior at eight weeks	34 score on a scale Interval 32.25 to 34.75	34 score on a scale Interval 31.5 to 35.0

SECONDARY outcome

Timeframe: Baseline and after four, eight weeks

Population: One participant lost at four 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.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Diabtes-related Foot Ulcer Self-management Self-efficacy self-management self-efficacy at four weeks	97.5 score on a scale Interval 93.625 to 103.0	95.0 score on a scale Interval 88.125 to 103.25
Diabtes-related Foot Ulcer Self-management Self-efficacy self-management self-efficacy at eight weeks	98.5 score on a scale Interval 93.5 to 102.5	98.0 score on a scale Interval 87.0 to 102.25

SECONDARY outcome

Timeframe: Baseline and after four, eight weeks

Population: One participant lost at four 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.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Diabetes Self-care Behaviors SDSCA at four weeks	37.0 score on a scale Interval 31.0 to 47.5	35.0 score on a scale Interval 26.75 to 42.25
Diabetes Self-care Behaviors SDSCA at eight weeks	35.50 score on a scale Interval 30.0 to 49.75	35.0 score on a scale Interval 28.75 to 39.25

SECONDARY outcome

Timeframe: Baseline and after four, eight weeks

Population: One participant lost at four 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.

Outcome measures

Measure	Intervention n=16 Participants 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.	Comparison n=14 Participants Routine care
Diabetes-related Foot Self-care Behavior Diabetes-related foot self-care behavior at four weeks	22.0 score on a scale Interval 17.0 to 25.0	23.0 score on a scale Interval 17.25 to 25.0
Diabetes-related Foot Self-care Behavior Diabetes-related foot self-care behavior at eight weeks	22.0 score on a scale Interval 19.5 to 25.0	22.50 score on a scale Interval 17.25 to 24.25

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yen-Fan Chin

Chang Gung University, Taiwan

Phone: 032118800

Email: yenfan@mail.cgu.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place