Digital Foot Self-Management Program for Older-Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Taiwanese Digital Foot Self-Management Program for Older-Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272670
• Other study ID #: TSMH IRB-20-084-B
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: July 2022
• Source: Fooyin University
• Contact: Shu-Ming Chen
• Phone: 886-7-7811151
• Email: ft036[@]fy.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Metabolic Diseases
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Fooyin University	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Fooyin University

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Chen SM, Lin HS, Atherton JJ, MacIsaac RJ, Wu CJ. Effect of a mindfulness programme for long-term care residents with type 2 diabetes: A cluster randomised controlled trial measuring outcomes of glycaemic control, relocation stress and depression. Int J Older People Nurs. 2020 Sep;15(3):e12312. doi: 10.1111/opn.12312. Epub 2020 Feb 26. — View Citation

Wu CJ, Atherton JJ, MacIsaac RJ, Courtney M, Chang AM, Thompson DR, Kostner K, MacIsaac AI, d'Emden M, Graves N, McPhail SM. Effectiveness of the cardiac-diabetes transcare program: protocol for a randomised controlled trial. BMC Health Serv Res. 2017 Feb 2;17(1):109. doi: 10.1186/s12913-017-2043-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Care Self-Efficacy Scale	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	Diabetic Foot Self-Care Behavior Scale	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
Secondary	HbA1c level	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
Secondary	Health promotion satisfaction	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