Clinical trial NCT04467606: Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers
Official title: Institutional Review Board Chang Gung Medical Foundation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Foot ulcer, motivational interviewing, discharge planning
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to either the experimental or the comparison group.
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers

Detailed description: The purpose of this study is to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers.

A randomized controlled trial design will be used. From August 2020 to July 2022, 132 patients hospitalized for diabetic foot ulcers will be recruited. They will be randomly assigned to either the experimental or the comparison group in the first year, and then they will be followed by one year. The control group will receive routine care; the experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. Outcome measures include diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, glycemic control (measured by HbA1C), the infection rate of foot, and the readmission rate. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.

The generalized estimating equation (GEE) will be used to evaluate the effect of the intervention on the diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, and the effect on glycated hemoglobin value reduction. The log-rank test will be used to compare the infection rate of foot, and the readmission rate between two groups.

Eligibility criteria: Inclusion criteria DFU inpatient Could communicate with Mandarin or Taiwanese HbA1C value higher or equal to 7.5 % Wagner stage 1 or 2 foot ulcer. Exclusion criteria Cognitive impairment Communication problems Affected foot has been amputated Autoimmune disease Be unable to perform daily self-care activity Be cared by foreigner and no other family members live together Plan to move to a long-term care facility Unwilling to visit the outpatient clinic at the research setting C-reactive protein values are higher than 15 mg/dL

Primary outcomes:
measure: Rate of foot infection and readmission for foot ulcer
timeFrame: 5 minutes
Secondary outcomes:
measure: Glycemic control
timeFrame: 1 minutes
measure: Foot skin conditions
timeFrame: 1 minutes
measure: Knowledge regarding warning signs of diabetic foot ulcer
timeFrame: 5 minutes
measure: Diabetes Foot Self-Care Behavior
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-care
timeFrame: 1 Minute
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: Chang Gung University
name: Yen-Fan Chin, PhD
role: PRINCIPAL_INVESTIGATOR
References: