Clinical trial NCT03993990: Effects of Empowerment-based Program on Post-discharge Glycemic Control, and Foot Ulcer
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes、Foot ulcer、Self-care、glycemic control、Empowerment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Glycemic control
timeFrame: Less than 1 minute
measure: Foot infection and recurrence of foot ulcer
timeFrame: 5 minutes
Secondary outcomes:
measure: Knowledge regarding warning signs of diabetic foot ulcer
timeFrame: 5 minutes
measure: Self-care behaviors of foot care
timeFrame: 3 minutes
measure: Self-care behaviors of diabetes
timeFrame: 4 minutes
measure: Diabetes-related Foot Ulcer Self-Management Behavior
timeFrame: 9 minutes
measure: Diabetes Management Self-Efficacy
timeFrame: 10 minutes
measure: Self-efficacy regarding diabetes foot self-car
timeFrame: 1 minutes
measure: Self-efficacy regarding diabetes-related foot ulcer self-management
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Assistant Professor
name: Yenfan Chin, PhD
role: PRINCIPAL_INVESTIGATOR
References: