- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07519096
Steady Together Fall Prevention Program in the Home
The purpose of the research study is to assess the efficacy of the occupational therapy Steady Together Fall Prevention Program in the Home for persons with Parkinson's Disease (PwP) who are members of InMotion. InMotion is a community wellness center that offers a variety of programs for PwP. The goal of the program is to prolong safe and independent living of PwP within their homes through fall prevention. Objectives are: 1) to identify areas in the home that are barriers to safe and accessible functioning for PwP with a focus on fall prevention; 2) To recommend assistive equipment, performance strategies, and home modifications as well as helpful resources to enhance safety and accessibility within the home. 3) to improve accessibility of the home; 4) to improve the PwP's safety confidence within their home.
Research questions are:
- Do participants have improved safety confidence in their homes as relates to falls after completing the program
- Is home more accessible after completing program
- What areas of the home pose the most fall risk among this population
- What types of modifications and assistive devices help to reduce falls among this population
- Does the program help to reduce falls among this population
Participants will complete an initial intake form (30 minutes); they will participate in a 2 hour home assessment performed by occupational therapists using the Home for Life Design (HfLD platform in which they will be asked to identify areas of their home they have fall safety concerns; they will rate the safety of these spaces; they will demonstrate activities of daily living done in spaces and the occupational therapist will rate accessibility of these spaces; they will participate in a 30 minute meeting with the occupational therapist to review report with recommendations and resources and develop an agreed upon action plan; they will implement action plan; they will participate in a one hour reassessment; participate in a follow up 30 minute phone interview one year later. Total time commitment is 4 hours.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using the HfLD platform, the OT will work collaboratively with the client and care partner/family member(s) during the delivery of the Steady Together program. The program includes the following (after obtaining informed consent):
- Initial intake questionnaire. 30 minutes. Participants (members) will be asked to complete an initial online intake survey that will be located on qualtrics.
First 2 hour session in home:
- Interview questions will include questions about fall history, places in the home and/or daily activities that are of concern to the client and/or care partner, and client's relevant medical history. OT will ask the client to identify up to 5 areas/rooms within the home that are of most concern and rank them as most important to address (most important to least important).
- Rate Personal Safety for each room assessed: For each room identified as of concern, the OT will ask the client to rate their personal safety (Personal Safety Rating- PSR) using a 10 point Likert Scale (0=do not feel safe; 10= feels safe). The HfLD application will automatically convert scaled scores for each room to percentages.
- For each room identified as of concern, the OT will observe the client perform their typical daily activities within the room to assess the accessibility of each room using the HfLD tool. The OT will use the Accessibility Rating (AR) scale: 0= not accessible; 5= partially accessible; 10=fully accessible (see attached scale). The HfLD application will automatically convert the scaled scores for each room to percentages.
- During the home assessment, the OT, using clinical expertise, will discuss options with client and care partner, such as assistive equipment, alternative performance strategies, and/or home modifications that can be made to support the client's continued safety and independence at home.
Meet with OT to review report via zoom or phone: 30 minutes.
- The OT will prepare a report using the HfLD platform. Based on the findings and their clinical expertise, the OT report will provide a summary of findings, including Personal Safety Ratings and Accessibility Ratings for each room. It will identify barriers interfering with performance and provide environmental, equipment, or performance strategy recommendations, and useful resources to promote safety and accessibility within the home. The OT will provide client-centered recommendations. The report will include photographs of areas within the various rooms that identify areas of concern allowing the OT to illustrate directly on the photos where equipment should be installed, furniture moved, etc. Photos will not have people in them. The OT will send a link to the report to the client. The client can then download the report if they choose to do so. (See attached report sample).
- The OT will meet for 30 minutes with the client via zoom or telephone to review the report, answer any questions, and discuss an action plan that is practical for the client.
- Client will implement agreed upon recommendations within approximately 1-2 months from time of report review. This is done independently or with assistance of care partner/family. Resources will be provided to members to assist them in finding a handyman or community resources that may provide financial assistance or access to assistive equipment.
- Follow-up re-assessment in home by OT after recommendations are implemented by client: 1 hour The client will need to provide new PSRs for designated rooms and demonstrate performance within rooms again so the OT can reassess accessibility ratings of the specified rooms. The OT will rate overall compliance
- One year follow-up phone call interview by OT to answer questions about fall experiences/frequencies. 30 minutes.
- Occupational therapy services provided will fall within the occupational therapy scope of practice of the State of Ohio.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joanna DeMarco, DHSc
- Phone Number: 216-687-3553
- Email: j.l.reid@csuohio.edu
Study Contact Backup
- Name: Beth Ekelman, PhD
- Phone Number: 216-544-3109
- Email: b.ekelman@csuohio.edu
Study Locations
-
-
Ohio
-
Beachwood, Ohio, United States, 44122
- Recruiting
- InMotion Wellness Center
-
Contact:
- Cathe Schwartz
- Phone Number: 216-342-4417
- Email: cschwartz@beinmotion.org
-
Contact:
- Ben Rossi
- Phone Number: 216-342-4417
- Email: brossi@beinmotion.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older Parkinson's disease Member of InMotion Care Partner of member Participating in InMotion Fall Prevention program Has completed the MoCA
Exclusion Criteria:
- Unable to make own medical decisions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Steady Together Fall Prevention Program in the Home
|
Interventions focus on fall prevention in the home for people with Parkinsons disease.
Collaborative action plan developed based on initial assessment.
Interventions address issues that may be more relevant for this population.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Safety Rating
Time Frame: From initial assessment to reassessment at one month after implementation of action plan
|
Participants rate how safe they feel in each room
|
From initial assessment to reassessment at one month after implementation of action plan
|
|
Accessibility Rating
Time Frame: From initial assessment to reassessment at one month after implementation of action plan
|
Rating of accessibility of each room or space in home
|
From initial assessment to reassessment at one month after implementation of action plan
|
|
Fall frequency
Time Frame: From initial assessment to reassessment at one month after action plan implemented, in addition to one year follow up.
|
Number of falls or near falls
|
From initial assessment to reassessment at one month after action plan implemented, in addition to one year follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall safety rating performing daily activities
Time Frame: Ratings are collected one year after interventions are completed.
|
One year follow up includes asking participants their overall safety rating performing daily activities on scale of 0-10.
This includes asking them to compare if they feel safer doing activities compared on one year ago.
|
Ratings are collected one year after interventions are completed.
|
|
Risk of falling
Time Frame: Information is collected one year after interventions are completed
|
Asks participants to report whether they perceive changes in their risk of falling
|
Information is collected one year after interventions are completed
|
|
Overall compliance with action plan
Time Frame: From action plan meeting and implementation of plan to reassessment one month later.
|
Rates compliance of participants specific to action plan
|
From action plan meeting and implementation of plan to reassessment one month later.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joanna DeMarco, DHSc, Cleveland State University
- Study Director: Stephen Slane, PhD, Cleveland State University
- Study Director: Beth Ekelman, PhD, Cleveland State University and Beth A Ekelman, PhD, JD, OTR/L LLC
- Study Director: Susan Wayne, MEd, SLW Therapy Services, LLC
- Study Director: Cathe Schwartz, InMotion Orthopaedic Research Center
- Study Director: Ben Rossi, ACE-CPT, InMotion Orthopaedic Research Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2026-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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