Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Foot Ulcer | Behavioral: individual empowerment-based intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | July 31, 2021 |
Estimated Study Completion Date : | July 31, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental group
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).
|
Behavioral: individual empowerment-based intervention
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.
|
No Intervention: Control group
Participants will receive routine care of the research setting only. The counseling will be provided if participants request.
|
Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
Chang Gung Memorial Hospital | |
Taoyuan City, Taiwan |
Principal Investigator: | Yenfan Chin, PhD | Assistant Professor |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 20, 2019 | ||||
First Posted Date ICMJE | June 21, 2019 | ||||
Last Update Posted Date | July 24, 2019 | ||||
Estimated Study Start Date ICMJE | August 1, 2019 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer | ||||
Official Title ICMJE | 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 | ||||
Brief 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. 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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Prevention |
||||
Condition ICMJE | Diabetic Foot Ulcer | ||||
Intervention ICMJE | Behavioral: individual empowerment-based intervention
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 Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
160 | ||||
Estimated Study Completion Date ICMJE | July 31, 2021 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Taiwan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03993990 | ||||
Other Study ID Numbers ICMJE | 201802180B0 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Chin yenfan, Chang Gung Memorial Hospital | ||||
Study Sponsor ICMJE | Chin yenfan | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Chang Gung Memorial Hospital | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |