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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lindsey A MacFarlane, MD, MPH
- 電話番号：(603) 650-8622
- メール：Lindsey.A.MacFarlane@hitchcock.org
研究場所
-
-
New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth-Hitchcock Medical Center
-
コンタクト：
- Lindsey A MacFarlane, MD, MPH
- 電話番号：603-650-8622
- メール：Lindsey.A.MacFarlane@hitchcock.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
時間枠：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
時間枠：Baseline
|
Descriptive feasibility outcome, a 5 point likert scale used to determine patient willingness to participate in the research. |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Use, dose, and frequency of analgesics
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY02003585
- 1P20GM161873-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。