Diabetic Foot UlcerNCT03993990
Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer
A study testing individual empowerment-based intervention in people with Diabetic Foot Ulcer, run by Chin yenfan at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- individual empowerment-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes
- Age between 20 and 80 years old.
- Could communicate with Mandarin or Taiwanese.
- The glycated hemoglobin value is higher or equal to 7.5%.
- The vibration or monofilament test results are abnormal.
- Wagner stage 1 or 2 foot ulcer
- The location of ulcer is at the big toes or on the sole
Who cannot join
- Cognitive impairment
- Severe lower extremity arterial insufficiency disease
- Osteomyelitis or foot ulcer recurrent
- Alcoholism or Drug addiction
- Autoimmune disease
- Unable to perform daily self-care activity
Show all 10Show fewer
- The main caregivers are foreigner and no other family members live together
- The C-reactive protein values are higher than 15 mg/dL
- Admitting in a long-term care institution after discharge from hospital
- No intention of the return-visit at the clinic of research hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Empowerment-based Program on Post-discharge Self-care Behavior, Glycemic Control, and Prevention of Foot Ulcer Infection and Occurrence in Patients With Diabetic Foot Ulcer
The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.
Read the detailed description
A randomized controlled trial design will be used to evaluate an empowerment-based program.. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge
- Conditions
- Diabetic Foot Ulcer
- Being tested
- individual empowerment-based intervention
- Keywords
- Diabetes、Foot ulcer、Self-care、glycemic control、Empowerment
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual empowerment-based interventionBehavioural
Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). After the principal investigator delivers a pre-discharge assessment (i. e. the self-care behavior and self-efficacy of diabetes and diabetic foot ulcer, risk factors of foot ulcer, family support, and threat belief of participant), the plan of behavioral modification will be determined by the principal investigator and participants. The subsequent follow-up and intensifying interventions will be delivered at the following time points: three days after discharge, every weeks for one month, every two weeks for subsequent two months, and then every three months for three times.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). Receives: Behavioral: individual empowerment-based intervention |
| Control group | 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.
Glycemic control
Glycated hemoglobin value
Measured: Less than 1 minute
Foot infection and recurrence of foot ulcer
Foot assessment and the review of medical record
Measured: 5 minutes
Secondary outcomes (7)
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.
Measured: 5 minutes
Self-care behaviors of foot care
The Diabetes Foot Self-Care Behavior Scale (DFSBS) The DFSBS contains 7 items. The scale had two parts: In the first part, the responses were rated on the number of days patients performed a certain behavior over the course of one week. In the second part, the responses were rated by the frequency with which patients performed a certain behavior in general, from never (1) to always (5).
Measured: 3 minutes
Self-care behaviors of diabetes
The Chinese version of summary of diabetes self-care activity questionnaire (C-SDSCA) The 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.)
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).
Measured: 9 minutes
Diabetes Management Self-Efficacy
The Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES) was a self-administered scale containing 20 items. It assessed the extent to which respondents were confident that they could manage their blood sugar, diet, and level of exercise. Responses were rated on a 10-point Likert-style from not at all (1) to certainly can do (10). The responses were summed to become a total score for "self-efficacy". Possible scores ranged 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-car
Two items were 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 were rated on a 10-point Likert-style scale according the degree of confidence.
Measured: 1 minutes
Self-efficacy regarding diabetes-related foot ulcer self-management
The 16-item diabetes-related foot ulcer self-management self-efficacy scale was used to measure the confidence in delivering diabetic foot ulcer self-management behavior, and management of diabetic foot ulcer. Responses were 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 posted21 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: Lack of financial resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chin yenfan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chin yenfan, Chang Gung Memorial Hospital
- Investigators
- Yenfan Chin, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993990
- Sponsor's protocol ID
- 201802180B0
- Status last verified
- Jul 2019
- First submitted
- 20 Jun 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empowerment-based Program on Post-discharge Self-care Behavior, Glycemic Control, and Prevention of Foot Ulcer Infection and Occurrence in Patients With Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03993990
- Acronym / sponsor ID
- 201802180B0
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes、Foot ulcer、Self-care、glycemic control、Empowerment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chin yenfanUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 21 Jun 2019 (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 purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.
Detailed description
A randomized controlled trial design will be used to evaluate an empowerment-based program.. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: individual empowerment-based interventionParticipants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). |
| Control group | 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diabetes
- Age between 20 and 80 years old.
- Could communicate with Mandarin or Taiwanese.
- The glycated hemoglobin value is higher or equal to 7.5%.
- The vibration or monofilament test results are abnormal.
Key exclusion criteria (10 listed)
- Cognitive impairment
- Severe lower extremity arterial insufficiency disease
- Osteomyelitis or foot ulcer recurrent
- Alcoholism or Drug addiction
- Autoimmune disease
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 |
|---|---|---|
| individual empowerment-based interventionParticipants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). After the principal investigator delivers a pre-discharge assessment (i. e. the self-care behavior and self-efficacy of diabetes and diabetic foot ulcer, risk factors of foot ulcer, family support, and threat belief of participant), the plan of behavioral modification will be determined by the principal investigator and participants. The subsequent follow-up and intensifying interventions will be delivered at the following time points: three days after discharge, every weeks for one month, every two weeks for subsequent two months, and then every three months for three times. | Behavioural | Experimental group |
Primary outcome
Glycemic control
Time frame: Less than 1 minute
Glycated hemoglobin value
Foot infection and recurrence of foot ulcer
Time frame: 5 minutes
Foot assessment and the review of medical record
7 secondary outcomes
Knowledge regarding warning signs of diabetic foot ulcer
Time frame: 5 minutes
Self-care behaviors of foot care
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-car
Time frame: 1 minutes
Self-efficacy regarding diabetes-related foot ulcer self-management
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
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.
Yenfan Chin, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual empowerment-based intervention in people with Diabetic Foot Ulcer, run by Chin yenfan 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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Jul 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Glycemic control (time frame: Less than 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.