Digital Foot Self-Management Program for Older-Diabetes
NCT ID: NCT05272670
Last Updated: 2022-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-02-15
2022-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental group
A 4-week digital foot self-management program will be provided to the participants in experimental group.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≧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
* Cognitive impairments.
* Unable to read and speak Chinese
65 Years
85 Years
ALL
No
Sponsors
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Fooyin University
OTHER
Responsible Party
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Shu-Ming Chen
Associate Professor
Principal Investigators
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Fooyin University
Role: PRINCIPAL_INVESTIGATOR
Nursing Department
Locations
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Fooyin University
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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TSMH IRB-20-084-B
Identifier Type: -
Identifier Source: org_study_id
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