Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers
Institutional Review Board Chang Gung Medical Foundation
1 other identifier
interventional
132
1 country
1
Brief Summary
To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 14, 2023
February 1, 2023
2.3 years
July 4, 2020
February 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of foot infection and readmission for foot ulcer
Foot assessment and the review of medical record
5 minutes
Secondary Outcomes (9)
Glycemic control
1 minutes
Foot skin conditions
1 minutes
Knowledge regarding warning signs of diabetic foot ulcer
5 minutes
Diabetes Foot Self-Care Behavior
3 Minutes
Self-care behaviors of diabetes
4 Minutes
- +4 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALThe experimental group will receive a discharge planning which use the strategy of motivational interviewing.
Control
NO INTERVENTIONParticipants will receive routine care of the research setting only. The counseling will be provided if participants request.
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Related Publications (1)
Chin YF, Yeh JT, Yu HY, Hsu BR, Lin YJ. A discharge planning program to prevent infection among patients with diabetic foot ulcers in Taiwan: A randomized controlled trial study. J Tissue Viability. 2025 Aug;34(3):100901. doi: 10.1016/j.jtv.2025.100901. Epub 2025 Apr 10.
PMID: 40280029DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yen-Fan Chin, PhD
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Research Fellow
Study Record Dates
First Submitted
July 4, 2020
First Posted
July 13, 2020
Study Start
August 1, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
February 14, 2023
Record last verified: 2023-02