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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lindsey A MacFarlane, MD, MPH
- Numéro de téléphone: (603) 650-8622
- E-mail: Lindsey.A.MacFarlane@hitchcock.org
Lieux d'étude
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth-Hitchcock Medical Center
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Contact:
- Lindsey A MacFarlane, MD, MPH
- Numéro de téléphone: 603-650-8622
- E-mail: Lindsey.A.MacFarlane@hitchcock.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Délai: 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
Délai: Baseline
|
Descriptive feasibility outcome, a 5 point likert scale used to determine patient willingness to participate in the research. |
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Use, dose, and frequency of analgesics
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY02003585
- 1P20GM161873-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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