Clinical trial NCT05272670: Digital Foot Self-Management Program for Older-Diabetes
Official title: Taiwanese Digital Foot Self-Management Program for Older-Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot Care Self-Efficacy Scale
timeFrame: 4-week
Secondary outcomes:
measure: Diabetic Foot Self-Care Behavior Scale
timeFrame: 4-week
measure: HbA1c level
timeFrame: 12-week
measure: Health promotion satisfaction
timeFrame: 4-week
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Fooyin University
Study officials:
affiliation: Nursing Department
name: Fooyin University
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.