Digital Foot Self-Management Program for Older-Diabetes

July 1, 2022 updated by: Shu-Ming Chen, Fooyin University

Taiwanese Digital Foot Self-Management Program for Older-Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shu-Ming Chen
  • Phone Number: 7059 886-7-7811151
  • Email: ft036@fy.edu.tw

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
A 4-week digital foot self-management program will be provided to the participants in experimental group.
Behavioral: A digital foot self-management program
A 4-week digital foot self-management program based on Bandura's Self-Efficacy model. The proposed functions include 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. Which was developed for older adults with diabetic foot self-management by the study team. Week 1 one-hour face-to-face training session after participant recruitment and allocation. The outline session is 30 min to introduce key topics and function in the app platform, 15 min to install the app and to demonstrate the use of the app, 15min to discuss and practice. Week 2 to week 4 following phone call once per week at the end of week and LINE messages 3 times per week.by research nurse, who will encourage and monitor participant's compliance with the program at home by using the digital platform. Participants are informed that technical phone support is available during the trial.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Care Self-Efficacy Scale
Time Frame: 4-week
Foot care self-efficacy was assessed using the Foot Care Self Efficacy Scale consisted of 16 items to measure individual's competence to manage foot care. Cronbach's alpha was .72. There are 16 items on the self-made scale in this study. Scored using a five-point Likert scale: "completely disagree", "slightly disagree", "no opinion", "slightly agree" and "completely agree", with a maximum score of 80 and a minimum of 16; represented higher values indicate higher foot care self-efficacy (Chen, 2005). The reliability Cronbach's alpha values were 0.82 in this study. The scale was used at baseline and week 4 for participants in both control and experimental groups.
4-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic Foot Self-Care Behavior Scale
Time Frame: 4-week
Diabetic foot self-care behavior was assessed using the Diabetic Foot Self-Care Behavior Scale, a 7-item questionnaire. Cronbach's alpha was .73. The scale consists of seven questions, divided into two parts. The first part was the number of days of foot care activities and the second part was the frequency of foot care activities. On a 5-point Likert scale (never, 0 days a week= 1 point; rarely, 1-2 days a week= 2 points; sometimes, 3-4 days a week= 3 points; often, 5- 6 days a week= 4 points, 7 days a week= 5 points, with a maximum score of 35 and a minimum of 7. Represented higher scores indicate good foot self-care behavior (Chin & Huang, 2013). Internal consistency Cronbach's alpha was .89 and test-retest reliability was .92 in this study. The scale was used at baseline and 4-week for participants in both control and experimental groups.
4-week
HbA1c level
Time Frame: 12-week
HbA1c level was used to present glycemic control outcome. The HbA1c level higher than 6.5% indicate worse glycemic control. The outcome was measured at baseline and at 3 months. Data were obtained from participants' medical records.
12-week
Health promotion satisfaction
Time Frame: 4-week
Health promotion satisfaction will be assessed using the questionnaire of Senior Technology Acceptance Chinese version developed by Chen (Chen et al., 2020). Questionnaire consisted 4 domains: attitudinal beliefs, control beliefs, gerontechnology anxiety, health. This outcome will be measured at week 4 for participants in experimental groups.
4-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fooyin University

Investigators

  • Principal Investigator: Fooyin University, Nursing Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSMH IRB-20-084-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glucose Metabolism Disorders

Clinical Trials on A digital foot self-management program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe