Feasibility of Choose to Move Replacement Ready

Официальное название

Choose to Move Replacement Ready: A Feasibility Trial of a Virtual Health-promoting Intervention for People Awaiting Total Hip or Knee Replacement Surgery

Обзор

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

Подробное описание

Choose to Move (CTM) an effective 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. Choose to Move Replacement Ready (CTM-RR) is an adapted version of the program tailored to support individuals with hip and/or knee osteoarthritis on surgical waitlists for TKR/THR, with the overall goal of enhancing key health outcomes. Trained activity coaches hired by the Active Aging Society will deliver CTM-RR to individuals on surgical waitlists for TKR/THR. The investigators will then evaluate implementation of CTM-RR, and the impact of CTM-RR on participants' physical and social health.

The primary objective of this trial is to:

1. Assess implementation outcomes (participant recruitment, retention, dose delivered/received, fidelity) of the adapted CTM model against predetermined feasibility targets.

The secondary objectives are to: 2. Describe implementation determinants (acceptability, feasibility, appropriateness) and outcomes (reach, adaptations, perceived participant responsiveness, adoption) of the adapted CTM model. 3. Evaluate the preliminary estimates of effectiveness of CTM-RR. Specifically, whether CTM-RR increases participants' pre-operative moderate-to-vigorous physical activity, light physical activity, mobility, psychosocial health, and self-efficacy to manage their condition; improves their perception of their joint condition, function, and quality of life; and decreases pain, social isolation, loneliness, and sedentary time 4. Assess whether participant-level health benefits, if any, are maintained 3 months after participants complete the CTM-RR program.

In partnership with the Active Aging Society, the investigators aim to deliver 6 CTM-RR online programs over 9-months to approximately 60 participants total across BC. There is no cost to participate in the CTM-RR program, and individuals may participate in CTM-RR regardless of whether they choose to be evaluated as part of this trial.

The investigators will conduct a feasibility trial using a hybrid implementation-effectiveness type 2 trial design. Data will be collected at 0 (baseline), 3 (post-intervention), and 6 (long-term follow-up) months to assess implementation and impact of CTM-RR, and maintenance of any program-related benefits. The investigators will also collect physical activity logs from program participants (weekly, during program participation).

Вмешательства

• Поведенческое Choose to Move Replacement Ready
  As described under study arm description.

Первичные конечные точки

• Implementation Outcome: Recruitment [Срок оценки: baseline]
• Implementation Outcome: Retention [Срок оценки: baseline, 3, 6 months]
• Implementation Outcome: Dose delivered [Срок оценки: 3 months]
• Implementation Outcome: Dose received [Срок оценки: 3 months]
• Implementation Outcome: Fidelity (Proportion of participants who adhered to prescribed exercise) [Срок оценки: 3 months]
• Adverse events: Number of adverse events [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Change in physical activity [Срок оценки: baseline, 3, 6 months]
• Change in walking time [Срок оценки: baseline, 3, 6 months]
• Change in sedentary time [Срок оценки: baseline, 3, 6 months]
• Change in bone and muscle strengthening activity [Срок оценки: baseline, 3, 6 months]
• Change in balance activity [Срок оценки: baseline, 3, 6 months]
• Change in capacity for mobility [Срок оценки: baseline, 3, 6 months]
• Change in social isolation [Срок оценки: baseline, 3, 6 months]
• Change in loneliness [Срок оценки: baseline, 3, 6 months]
• Change in ability to participate in daily activities [Срок оценки: baseline, 3, 6 months]
• Change in Hip disability and Osteoarthritis Outcome 12-item Score [Срок оценки: baseline, 3, 6 months]
• Change in Knee disability and Osteoarthritis Outcome 12-item Score [Срок оценки: baseline, 3, 6 months]
• Change in patient global assessment of target joint [Срок оценки: baseline, 3, 6 months]

Критерии участия

Критерии включения

• Activity coach hired by the Active Aging Society (activity coaches must speak English to participate in the evaluation);
• English-speaking older adults (aged >=50 years) who participate in CTM-RR will be invited to participate in the evaluation
• Referral partner (People who work in a healthcare setting who refer patients into the program)

Критерии исключения

• non-English speaking activity coach
• non-English speaking referral partner

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Active Aging Research Team, Robert H. N. Ho Research Centre — Vancouver

Публикации

• Peer MA, Lane J. The Knee Injury and Osteoarthritis Outcome Score (KOOS): a review of its psychometric properties in people undergoing total knee arthroplasty. J Orthop Sports Phys Ther. 2013 Jan;43(1):20-8. doi: 10.2519/jospt.2013.4057. Epub 2012 Dec 7. PMID 23221356
• Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003 May 30;4:10. doi: 10.1186/1471-2474-4-10. Epub 2003 May 30. PMID 12777182
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
• Hawker GA, Bohm E, Dunbar MJ, Faris P, Jones CA, Noseworthy T, Ravi B, Woodhouse LJ, Marshall DA; BEST-Knee Study Team. Patient appropriateness for total knee arthroplasty and predicted probability of a good outcome. RMD Open. 2023 Apr;9(2):e002808. doi: 10.1136/rmdopen-2022-002808. PMID 37068914
• Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018. PMID 29731662
• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9. PMID 3785962
• Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88. PMID 9699158
• Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol. 2003;32(1):46-51. doi: 10.1080/03009740310000409. PMID 12635946

Идентификаторы

NCT: NCT07069179 · H24-03805

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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