Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer
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|ClinicalTrials.gov Identifier: NCT03993990|
Recruitment Status : Withdrawn (Lack of financial resources)
First Posted : June 21, 2019
Last Update Posted : July 24, 2019
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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
- Knowledge regarding warning signs of diabetic foot ulcer [ Time Frame: 5 minutes ]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.
- Self-care behaviors of foot care [ Time Frame: 3 minutes ]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).
- Self-care behaviors of diabetes [ Time Frame: 4 minutes ]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.)
- Diabetes-related Foot Ulcer Self-Management Behavior [ Time Frame: 9 minutes ]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).
- Diabetes Management Self-Efficacy [ Time Frame: 10 minutes ]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.
- Self-efficacy regarding diabetes foot self-car [ Time Frame: 1 minutes ]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.
- Self-efficacy regarding diabetes-related foot ulcer self-management [ Time Frame: 5 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993990
|Chang Gung Memorial Hospital|
|Taoyuan City, Taiwan|
|Principal Investigator:||Yenfan Chin, PhD||Assistant Professor|