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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Lindsey A MacFarlane, MD, MPH
- Telefonnummer: (603) 650-8622
- E-post: Lindsey.A.MacFarlane@hitchcock.org
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth-Hitchcock Medical Center
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Ta kontakt med:
- Lindsey A MacFarlane, MD, MPH
- Telefonnummer: 603-650-8622
- E-post: Lindsey.A.MacFarlane@hitchcock.org
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Tidsramme: 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
Tidsramme: Baseline
|
Descriptive feasibility outcome, a 5 point likert scale used to determine patient willingness to participate in the research. |
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Use, dose, and frequency of analgesics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY02003585
- 1P20GM161873-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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