NCT04467606

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

July 4, 2020

Last Update Submit

February 13, 2023

Conditions

Keywords

Foot ulcer, motivational interviewing, discharge planning

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

EXPERIMENTAL

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

Behavioral: a discharge planning using the strategy of motivational interviewing

Control

NO INTERVENTION

Participants 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.

Experimental

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

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.

MeSH Terms

Conditions

Diabetic FootFoot Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesFoot Diseases

Study Officials

  • Yen-Fan Chin, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

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

Locations