Diabetic Foot UlcerNCT04467606
Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers
A study testing a discharge planning using the strategy of motivational interviewing in people with Diabetic Foot Ulcer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- a discharge planning using the strategy of motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 30 Nov 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria DFU inpatient Could communicate with Mandarin or Taiwanese HbA1C value higher or equal to 7.5 % Wagner stage 1 or 2 foot ulcer. Exclusion criteria Cognitive impairment Communication problems Affected foot has been amputated Autoimmune disease Be unable to perform daily self-care activity Be cared by foreigner and no other family members live together Plan to move to a long-term care facility Unwilling to visit the outpatient clinic at the research setting C-reactive protein values are higher than 15 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Institutional Review Board Chang Gung Medical Foundation
To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers
Read the detailed description
The purpose of this study is to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers.
A randomized controlled trial design will be used. From August 2020 to July 2022, 132 patients hospitalized for diabetic foot ulcers will be recruited. They will be randomly assigned to either the experimental or the comparison group in the first year, and then they will be followed by one year. The control group will receive routine care; the experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. Outcome measures include diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, glycemic control (measured by HbA1C), the infection rate of foot, and the readmission rate. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.
The generalized estimating equation (GEE) will be used to evaluate the effect of the intervention on the diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, and the effect on glycated hemoglobin value reduction. The log-rank test will be used to compare the infection rate of foot, and the readmission rate between two groups.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- a discharge planning using the strategy of motivational interviewing
- Keywords
- Foot ulcer, motivational interviewing, discharge planning
- Medical subject headings
- Diabetic Foot, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a discharge planning using the strategy of motivational interviewingBehavioural
The experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will receive a discharge planning which use the strategy of motivational interviewing. Receives: Behavioral: a discharge planning using the strategy of motivational interviewing |
| Control | No intervention | Participants will receive routine care of the research setting only. The counseling will be provided if participants request. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of foot infection and readmission for foot ulcer
Foot assessment and the review of medical record
Measured: 5 minutes
Secondary outcomes (9)
Glycemic control
Review the Glycated hemoglobin value on the medical record
Measured: 1 minutes
Foot skin conditions
Foot assessment
Measured: 1 minutes
Knowledge regarding warning signs of diabetic foot ulcer
The WS-DFUD-KQ comprises of 12 items. Three of the 12 items are negatively worded and state as misconceptions regarding warning signs of diabetic foot ulcer deterioration (i.e. item 8, 9, 10). The response choices include "yes," "no," and "uncertain." Each item with the correct answer obtains a score of 1, after which the scores are summed to obtain a total score. The higher scores represent better knowledge. The total WS-DFUD-KQ score ranges 0-12.
The content validity index of each of the 12 items was above 0.8. The item difficulty of the 12 items of the WS-DFUD-KQ ranged from 0.54 to 0.87, and the item discrimination index D values ranged from 0.42 to 0.83. The KR-20 of the WS-DFUD-KQ was 0.82. The Spearman's rho coefficient for test-retest reliability over a two-week period was 0.75.
Measured: 5 minutes
Diabetes Foot Self-Care Behavior
The Diabetes Foot Self-Care Behavior Scale (DFSBS) contains 7 items. The scale has two parts: In the first part, the responses are rated on the number of days patients performed a certain behavior over the course of one week. In the second part, the responses are rated by the frequency with which patients performed a certain behavior in general, from never (1) to always (5). When the score of the total scale is calculated, the number of days for each foot-care measure in the first part is categorized across 5 groups (0 days, 1-2 days, 3-4 days, 5-6 days, and 7 days). Thus, all items on the scale are rated on a 5-point Likert-type scale with the higher scores represented better foot self-care behaviors. The total DFSBS score ranges 7-35.
Measured: 3 Minutes
Self-care behaviors of diabetes
The Chinese version of summary of diabetes self-care activity questionnaire (C-SDSCA) is a short self-reported questionnaire of diabetes self-management across five components of diabetes regimen a person with diabetes should practice in order to stay well ( i. e. diet, exercise, blood sugar testing, foot care and attention to smoking). The number of days for each diabetes self-management behavior is measured. The higher scores represented better self-care behaviors of diabetes. The total C-SDSCA score ranges 11-77.
Measured: 4 Minutes
Diabetes-related Foot Ulcer Self-Management Behavior
The Diabetes-related Foot Ulcer Self-Management Behavior Scale (DFUSMBS) measures behaviors that patients use to manage their diabetes-related foot ulcers to promote wound healing and to prevent the deterioration of their wounds, including timely treatment seeking and management, wound management, and self-management of diabetes. The 18-item scale includes three reverse-scored items (Item 1, 2, 11) and uses a 5-point Likert scale (1 = never, 2 = seldom, 3 = sometimes, 4 = frequently, and 5 = always). The higher scores represent better diabetes-related foot ulcer self-management behaviors. The total DFUSMBS score ranges 18-90.
Measured: 9 Minutes
Diabetes management self-efficacy
The Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES) is a self-administered scale containing 20 items. It assesses the extent to which respondents are confident that they could manage their blood sugar, diet, and level of exercise. Responses are rated on a 10-point Likert-style from not at all (1) to certainly can do (10). The responses are summed to become a total score for "self-efficacy". Possible scores range from 0 to 200 points. The tool had acceptable reliability and validity in a Taiwanese population.
Measured: 10 Minutes
Self-efficacy regarding diabetes foot self-care
Two items will be used to measure the self-efficacy regarding diabetes foot self-care of participants. They are "I have confidence to check my feet (including the bottom of my feet and between the toes) daily, either by myself or to ask for someone's help.", and "I have confidence to apply moisturizing lotion to my feet by myself or asking for someone's help, If my skin is dry". Responses are rated on a 10-point Likert-style scale according the degree of confidence.
Measured: 1 Minute
Self-efficacy regarding diabetes-related foot ulcer self-management
The 16-item diabetes-related foot ulcer self-management self-efficacy scale will be used to measure the confidence in delivering diabetic foot ulcer self-management behavior, and management of diabetic foot ulcer. Responses are rated on a 10-point Likert-style from not at all (1) to certainly can do (10). The higher score indicates better self-efficacy.
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Aug 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Subjects will be randomly assigned to either the experimental or the comparison group.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin yenfan, Chang Gung Memorial Hospital
- Investigators
- Yen-Fan Chin, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467606
- Sponsor's protocol ID
- 201901813B0
- Status last verified
- Feb 2023
- First submitted
- 4 Jul 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chin YF, Yeh JT, Yu HY, Hsu BR, Lin YJ. A discharge planning program to prevent infection among patients with diabetic foot ulcers in Taiwan: A randomized controlled trial study. J Tissue Viability. 2025 Aug;34(3):100901. doi: 10.1016/j.jtv.2025.100901. Epub 2025 Apr 10.
PubMed 40280029
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Review Board Chang Gung Medical Foundation
- ClinicalTrials.gov ID
- NCT04467606
- Acronym / sponsor ID
- 201901813B0
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Foot ulcer, motivational interviewing, discharge planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Jul 2020 (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.
To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers
Detailed description
The purpose of this study is to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers.
A randomized controlled trial design will be used. From August 2020 to July 2022, 132 patients hospitalized for diabetic foot ulcers will be recruited. They will be randomly assigned to either the experimental or the comparison group in the first year, and then they will be followed by one year. The control group will receive routine care; the experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. Outcome measures include diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, glycemic control (measured by HbA1C), the infection rate of foot, and the readmission rate. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.
The generalized estimating equation (GEE) will be used to evaluate the effect of the intervention on the diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, and the effect on glycated hemoglobin value reduction. The log-rank test will be used to compare the infection rate of foot, and the readmission rate between two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to either the experimental or the comparison group.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: a discharge planning using the strategy of motivational interviewingThe experimental group will receive a discharge planning which use the strategy of motivational interviewing. |
| Control | No intervention | –Participants will receive routine care of the research setting only. The counseling will be provided if participants request. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 discharge planning using the strategy of motivational interviewingThe experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. | Behavioural | Experimental |
Primary outcome
Rate of foot infection and readmission for foot ulcer
Time frame: 5 minutes
Foot assessment and the review of medical record
9 secondary outcomes
Glycemic control
Time frame: 1 minutes
Foot skin conditions
Time frame: 1 minutes
Knowledge regarding warning signs of diabetic foot ulcer
Time frame: 5 minutes
Diabetes Foot Self-Care Behavior
Time frame: 3 Minutes
Self-care behaviors of diabetes
Time frame: 4 Minutes
Diabetes-related Foot Ulcer Self-Management Behavior
Time frame: 9 Minutes
Diabetes management self-efficacy
Time frame: 10 Minutes
Self-efficacy regarding diabetes foot self-care
Time frame: 1 Minute
Self-efficacy regarding diabetes-related foot ulcer self-management
Time frame: 5 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 40280029Chin YF, Yeh JT, Yu HY, Hsu BR, Lin YJ. A discharge planning program to prevent infection among patients with diabetic foot ulcers in Taiwan: A randomized controlled trial study. J Tissue Viability. 2025 Aug;34(3):100901. doi: 10.1016/j.jtv.2025.100901. Epub 2025 Apr 10.
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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.
Yen-Fan Chin, PhD principal investigator
Chang Gung University
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 discharge planning using the strategy of motivational interviewing in people with Diabetic Foot Ulcer, run by Chang Gung Memorial Hospital 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?
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: finished, as of the sponsor's last update on 14 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of foot infection and readmission for foot ulcer (time frame: 5 minutes). 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 NCT04467606, which also lists 1 linked publication.
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 14 Feb 2023.