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

Chin yenfan

Status: Withdrawn

Conditions: Diabetic Foot Ulcer

Treatments: Behavioral: individual empowerment-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03993990

201802180B0

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Experimental group

Experimental group

Description:

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).

Treatment:

Behavioral: individual empowerment-based intervention

Control group

No Intervention group

Description:

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