- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07921563
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Knee Osteoarthritis is one of the most common causes of chronic joint pain. Although clinical guidelines recommend weight loss and regular physical activity as first line treatments this can be difficult for patients to do. This study aims to better understand what makes it harder or easier for patients to participate in weight management or exercise programs and to design a weight and exercise program specifically tailored to older adults managing chronic health issues.
Based on input from patients and providers we will design and pilot a virtual exercise and weight management program to help patients with knee osteoarthritis in their home. Participants will be asked to fill out questionnaires about their knee pain and have phone or video check-ins with the study team to monitor progress.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lindsey A MacFarlane, MD, MPH
- Phone Number: (603) 650-8622
- Email: Lindsey.A.MacFarlane@hitchcock.org
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
-
Contact:
- Lindsey A MacFarlane, MD, MPH
- Phone Number: 603-650-8622
- Email: Lindsey.A.MacFarlane@hitchcock.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinician-diagnosed osteoarthritis of the knee
- Obesity (BMI >30)
- Cardiovascular disease and/or diabetes mellitus
- English speaking
Exclusion Criteria:
- Inflammatory arthritis
- Antecedent acute trauma
- Consistent use of a wheelchair
- Moderate to severe dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-based exercise and weight management program
The foundation of the program will be based on current activity as well as weight guidelines and recommendations; adjustments will be made to maximize facilitators and minimize barriers identified in previous studies. |
This is the only intervention that will be assigned to participants. Program will be based on participant's current activity level and current weight guidelines. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Time Frame: 3 and 6 months
|
A valid, reliable, and responsive scale developed for use in studies of knee problems including osteoarthritis. |
3 and 6 months
|
|
Prospective preference assessment
Time Frame: Baseline
|
Descriptive feasibility outcome, a 5 point likert scale used to determine patient willingness to participate in the research. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use, dose, and frequency of analgesics
Time Frame: 3 and 6 months
|
Patient-reported counts of the use, dose, and frequency of pain medications used, including non-steroidal anti-inflammatory drugs |
3 and 6 months
|
|
Self-reported current weight
Time Frame: 3 and 6 months
|
Patients will be asked to self report their current weight at the defined time points |
3 and 6 months
|
|
Participant satisfaction and adherence
Time Frame: 3 and 6 months
|
Patient satisfaction will be measured using a 5 point Likert scale for a series of questions aimed at perceived effectiveness of the intervention, ease of use and likeliness of continuing in the intervention |
3 and 6 months
|
|
The Physical Activity Scale for the Elderly (PASE)
Time Frame: 3 and 6 months
|
A recommended and reliable assessment for physical activity in older adults that has demonstrated positive correlation with Actigraph monitor data |
3 and 6 months
|
Collaborators and Investigators
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02003585
- 1P20GM161873-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The phenotypic data associated with enrolled participants will be shared by depositing these data in the Open Science Framework data repository. Additional data documentation and de-identified IPD including demographics, diagnoses, and outcomes will be deposited. Resources such as study protocols and statistical analyses codes will also be made available.
IPD Sharing Time Frame
Outcome data will be deposited into the Open Science Framework repository as soon as possible but no later than within one year of the completion of the funded project period for the parent away or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier. Data will remain available for a period of 5 years.
IPD Sharing Access Criteria
Data and supporting information will be shared with investigators working in accordance to guidelines set by the data repository. Meta-analysis data and associated phenotypic data, along with data content, format, and organization will be made available to investigators through the Open Science Framework data repository.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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