Diabetes MellitusNCT05272670
Digital Foot Self-Management Program for Older-Diabetes
A study testing A digital foot self-management program in people with Diabetes Mellitus and Type 2 Diabetes, run by Fooyin University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes, Glucose Metabolism Disorders
- What is being tested?
- A digital foot self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Unable to perform physical activities.
- Cognitive impairments.
- Unable to read and speak Chinese
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fooyin University
Kaohsiung City, 83102
Shu-Ming Chen, ft036@fy.edu.tw
Shu-Hsien Lee, vin603168@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes, Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Diseases
- Being tested
- A digital foot self-management program
- Keywords
- Digital foot self-management, Foot care self-efficacy, Self-care behaviors
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Endocrine System Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital foot self-management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A 4-week digital foot self-management program will be provided to the participants in experimental group. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-week
Secondary outcomes (3)
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.
Measured: 4-week
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.
Measured: 12-week
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.
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start15 Feb 2022
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Ming Chen, Fooyin University
- Investigators
- Fooyin University, Principal investigator, Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272670
- Sponsor's protocol ID
- TSMH IRB-20-084-B
- Status last verified
- Jul 2022
- First submitted
- 28 Feb 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32103635Wu 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.
PubMed 28153000
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwanese Digital Foot Self-Management Program for Older-Diabetes
- ClinicalTrials.gov ID
- NCT05272670
- Acronym / sponsor ID
- TSMH IRB-20-084-B
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: A digital foot self-management programA 4-week digital foot self-management program will be provided to the participants in experimental group. |
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to perform physical activities.
- Cognitive impairments.
- Unable to read and speak Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A digital foot self-management programA 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. | Behavioural | Experimental group |
Primary outcome
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.
3 secondary outcomes
Diabetic Foot Self-Care Behavior Scale
Time frame: 4-week
HbA1c level
Time frame: 12-week
Health promotion satisfaction
Time frame: 4-week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 32103635Chen 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.
- Background: PubMed 28153000Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fooyin University principal investigator
Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital foot self-management program in people with Diabetes Mellitus and Type 2 Diabetes, run by Fooyin University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Ming Chen (886-7-7811151 ext. 7059, ft036@fy.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Care Self-Efficacy Scale (time frame: 4-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272670, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.