Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient satisfaction (change from baseline)
Study Overview
Brief Summary
The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.
Detailed Description
Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members.
Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English speaking
- •Age 21 years or older
- •History of active DFU necessitating offloading
- •Capacity to provide informed consent
- •Access to telehealth (internet connection and equipment)
- •Ability to walk independently or with an assistive device
- •Self-reported life expectancy of more than one year
Exclusion Criteria
- •Self-reported deafness or blindness
- •history of lower extremity amputation besides toes
Arms & Interventions
Lifestyle-based intervention by an occupational therapist
Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist.
Intervention: Lifestyle-based intervention by an occupational therapist (Behavioral)
Outcomes
Primary Outcomes
Patient satisfaction (change from baseline)
Time Frame: Baseline and discharge from OT (3 to 8 weeks)
Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).
Secondary Outcomes
- Diabetes distress (change from baseline)(Baseline and discharge from OT (3 to 8 weeks))
- Offloading knowledge and attitudes (change from baseline)(Baseline and discharge from OT (3 to 8 weeks))
- Frequency of DFU-related outcomes(6-month post-enrollment)
Investigators
Tze-Woei Tan
Associate Professor of Clinical Surgery
University of Southern California