The Short Message-based Customized Standardized

NCT ID: NCT06037369

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2024-07-02

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

customized standardized educational program sent by LINE software.

Intervention Type: 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.

comparison

Routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chin yenfan

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yenfan Chin

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NSTC112-2314-B-182-028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NMRPD1N0241

Identifier Type: -

Identifier Source: org_study_id