Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer

July 23, 2019 updated by: Chin yenfan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Less than 1 minute
Glycated hemoglobin value
Less than 1 minute
Foot infection and recurrence of foot ulcer
Time Frame: 5 minutes
Foot assessment and the review of medical record
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 minutes
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).
3 minutes
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.)
4 minutes
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).
9 minutes
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.
10 minutes
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.
1 minutes
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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chin yenfan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yenfan Chin, PhD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201802180B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot Ulcer

Clinical Trials on individual empowerment-based intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings