Digital Foot Self-Management Program for Older-Diabetes

Fooyin University

Status: Enrolling

Conditions: Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Type 2 Diabetes; Endocrine System Diseases

Treatments: Behavioral: A digital foot self-management program

Study type: Interventional

Funder types: Other

Identifiers

NCT05272670

TSMH IRB-20-084-B

Details and patient eligibility

About

The aims of this proposed study are to evaluate the effect of a digital foot self-management program on the primary outcome of self-efficacy, and secondary outcomes of self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.

Full description

Literature reveals the needs for diabetic foot self-management intervention programs associated with positive changes in behavior. However, lack of studies focused on measure or improve health outcomes. Promoting effective diabetic foot care strategies in community is more critical than ever during a pandemic such as COVID.

This study are to evaluate the effect of a digital foot self-management program on self-efficacy, self-care behaviors, HbA1c and health promotion satisfaction for older adults with type 2 diabetes.

The contents of the 4-week program include: using a digital platform to providing foot self-management (checking conditions of foot, cleaning, cutting or removing corns and calluses, trimming, clipping nails, foot exercise, dietary related to foot care, foot care logs, etc). A developed digital platform as a self-help foot self-management education resource. The program specifically developed for older adults with diabetes to assist and management their own feet at homes. Week 1 face-to-face training session. Week 2 to week 4 following phone call once per week and LINE messages 3 times per week.by research nurse to encourage and monitor participant's compliance with the program at home by using the digital platform.

A total of 100 older adults with type 2 diabetes will be recruited from the 5 community clinics in southern Taiwan.A computerised random number generated by an independent statistician will be used to allocate each potential participant to the control or intervention group in a one-to-one ratio. All participants will be blinded to group allocation. Participants in control group will receive routine care provided in diabetes clinic, including routine check-ups and foot care education. While participants in the intervention group received the digital foot self-management program in addition to the routine care. Data will be collected at baseline and 4 weeks from baseline for self-efficacy, self-care behaviors,health promotion satisfaction and 12 weeks from baseline for HbA1c. The digital program will be delivered by trained registered nurse. A research assistant will be blinded to study protocol, who are employed to undertake data collection.

Enrollment: 100 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have been diagnosed with type 2 diabetes.
• ≧65 years.
• Possess and able to use a smart device (e.g. Samsung Galaxy, iPhone, iPad, tabletop)
• Are able to speak and comprehend Chinese

Exclusion criteria

• Unable to perform physical activities.
• Cognitive impairments.
• Unable to read and speak Chinese

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental group

Experimental group

Description:

A 4-week digital foot self-management program will be provided to the participants in experimental group.

Treatment:

Behavioral: A digital foot self-management program

Control group

No Intervention group

Description:

The control group received routine care that are required to attend the education sessions in the diabetes clinic according to their scheduled appointments. Routine care included routine check-ups and foot care education.