The Short Message-based Customized Standardized

NCT06037369 | Terminated Results

• 2 other identifiers: NMRPD1N0241NSTC112-2314-B-182-028
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Keywords

short message; wound healing; diabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Diabetes-related Foot Ulcer Self-management Behavior

  Baseline and after four, eight weeks

• Diabtes-related Foot Ulcer Self-management Self-efficacy

  Baseline and after four, eight weeks

• Diabetes Self-care Behaviors

  Baseline and after four, eight weeks

• Diabetes-related Foot Self-care Behavior

  Baseline and after four, eight weeks

Study Arms (2)

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

Behavioral: customized standardized educational program sent by LINE software.

comparison

NO INTERVENTION

Routine care

Interventions

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.

intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with foot ulcers
• Diagnosed as diabetic patients
• Can be interviewed in Mandarin or Taiwanese.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Yen-Fan Chin
• Organization: Chang Gung University, Taiwan

yenfan@mail.cgu.edu.tw

032118800

Study Officials

• Yenfan Chin

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Participants are assigned to two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: September 14, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Locations

TW (1)