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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lindsey A MacFarlane, MD, MPH
- Telefonnummer: (603) 650-8622
- E-post: Lindsey.A.MacFarlane@hitchcock.org
Studieorter
-
-
New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth-Hitchcock Medical Center
-
Kontakt:
- Lindsey A MacFarlane, MD, MPH
- Telefonnummer: 603-650-8622
- E-post: Lindsey.A.MacFarlane@hitchcock.org
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Tidsram: 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
Tidsram: Baseline
|
Descriptive feasibility outcome, a 5 point likert scale used to determine patient willingness to participate in the research. |
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Use, dose, and frequency of analgesics
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY02003585
- 1P20GM161873-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
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