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

NCT ID: NCT03993990

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-07-31

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

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

individual empowerment-based intervention

Intervention Type: BEHAVIORAL

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.

Control group

Participants will receive routine care of the research setting only. The counseling will be provided if participants request.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chin yenfan

OTHER

Sponsor Role: lead

Responsible Party

Chin yenfan

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yenfan Chin, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Other Identifiers

201802180B0

Identifier Type: -

Identifier Source: org_study_id