Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomly assigned to either the experimental or the comparison group.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

This study adopted a single blind study design. The research assistants who do not know the research object group perform pre- and post-test data collection, including interviews, medical record data collection and foot evaluation. Due to the different intervention measures received by the experimental group and the control group, we specifically advise the research subjects not to disclose the status of the intervention measures to the research assistant.

Study Groups

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Experimental

The experimental group will receive a discharge planning which use the strategy of motivational interviewing.

Group Type EXPERIMENTAL

a discharge planning using the strategy of motivational interviewing

Intervention Type BEHAVIORAL

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.

Control

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

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a discharge planning using the strategy of motivational interviewing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes