Digital Foot Self-Management Program for Older-Diabetes

NCT05272670 | Unknown DMC

• 1 other identifier: TSMH IRB-20-084-B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Digital foot self-management; Foot care self-efficacy; Self-care behaviors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diabetic Foot Self-Care Behavior Scale

  4-week

• HbA1c level

  12-week

• Health promotion satisfaction

  4-week

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: A digital foot self-management program

Control group

NO INTERVENTION

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.

Interventions

A digital foot self-management program BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Fooyin University

Kaohsiung City, 83102, Taiwan

RECRUITING

Related 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.

  PMID: 32103635 BACKGROUND

• 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.

  PMID: 28153000 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Fooyin University

  Nursing Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Ming Chen

CONTACT

886-7-7811151; ft036@fy.edu.tw

Shu-Hsien Lee

CONTACT

886-7-7811151; vin6063168@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized controlled trial will be used to examine the effectiveness of the digital foot self-management program. The outcomes included primary outcome of self-efficacy, and secondary outcomes of self-care behaviors, HbA1c and health promotion satisfaction. Participants in the intervention group will receive the digital foot self-management program in addition to routine care. The control group will receive routine care provided in diabetes clinic, including routine check-ups and foot care education.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: February 15, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)