Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers

Last updated: February 13, 2023
Sponsor: Chang Gung Memorial Hospital
Overall Status: Completed

Phase

N/A

Condition

Ulcers

Pressure Ulcer

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT04467606
201901813B0
  • Ages 20-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 132
Study Start date:
August 01, 2020
Estimated Completion Date:
November 30, 2022

Study 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.

Connect with a study center

  • Chang Gung Memorial Hospital

    Taoyuan City,
    Taiwan

    Site Not Available

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