Evaluation of Choose to Move Replacement Ready (CTM-RR)

Официальное название

Choose to Move Replacement Ready: Implementation and Effectiveness 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 goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. 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. Referral partners from hospitals and orthopaedic clinics in BC will inform patients about CTM-RR when they are booked for a hip or knee replacement surgery. Trained activity coaches hired by the Active Aging Society will deliver the online CTM-RR program to individuals on surgical waitlists for TKR/THR who register for the program. The investigators will then evaluate implementation of CTM-RR, impact of CTM-RR on participants' physical and social health, and maintenance of any health benefits.

The primary aim of this trial is to assess implementation and effectiveness of the adapted CTM-RR program. The specific objectives are to:

1. assess implementation of CTM-RR. Specifically, implementation determinants (context, acceptability, feasibility, appropriateness, self-efficacy) and implementation outcomes (1° implementation outcome: fidelity; 2° implementation outcomes: reach, retention, adoption, dose, adaptation, satisfaction). 2. evaluate effectiveness of CTM-RR. Specifically, whether CTM-RR increases participants' pre-operative moderate-to-vigorous physical activity (moderate to vigorous physical activity, 1° effectiveness outcome), mobility, psychosocial health, self-efficacy to manage their condition; improves their pain, function, quality of life, and perception of their joint condition, and decreases social isolation and loneliness (2° effectiveness outcomes). 3. evaluate if participant health benefits (if any) are maintained 3 months after CTM-RR is completed. 4. evaluate if participant health benefits (if any) are maintained up until participant's surgery (i.e. during the remaining surgical waiting period).

In partnership with the Active Aging Society, the investigators aim to deliver 20 CTM-RR online programs over two years to approximately 300 participants 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 expect approximately 70% of CTM-RR participants to volunteer for the evaluation.

The investigators will conduct a pre-post, observational cohort trial using a hybrid implementation effectiveness type 2 trial design. Data will be collected at 0 (baseline), 3 (postintervention), and 6 (long-term follow-up) months and 2-weeks before surgery (pre-operative) to assess implementation and impact of CTM-RR, and maintenance of any program-related benefits.

Вмешательства

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

Первичные конечные точки

• Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components) [Срок оценки: 3 months]
• Effectiveness outcome: Change in physical activity [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]

Вторичные конечные точки (12)

• Reach [Срок оценки: 3 months]
• Retention [Срок оценки: Baseline, 3 and 6 months, 2 weeks pre-operative]
• Dose delivered [Срок оценки: 3 months]
• Adoption [Срок оценки: 3 months]
• Adaptation (survey) [Срок оценки: 3 months]
• Satisfaction with CTM-RR (survey) [Срок оценки: 3 months]
• Change in walking time [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]
• Change in sedentary time [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]
• Change in bone and muscle strengthening activity [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]
• Change in balance activity [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]
• Change in capacity for mobility [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]
• Change in social isolation [Срок оценки: baseline, 3 and 6 months, 2 weeks pre-operative]

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

• Nettlefold L, Macdonald HM, Sims Gould J, Bauman A, Szewczyk Z, McKay HA. Does optimizing Choose to Move - a health-promoting program for older adults - enhance scalability, program implementation and effectiveness? Int J Behav Nutr Phys Act. 2024 Dec 18;21(1):140. doi: 10.1186/s12966-024-01649-9. PMID 39695643
• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. PMID 22310560
• Milton K, Bull FC, Bauman A. Reliability and validity testing of a single-item physical activity measure. Br J Sports Med. 2011 Mar;45(3):203-8. doi: 10.1136/bjsm.2009.068395. Epub 2010 May 19. PMID 20484314
• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574. PMID 18504506
• Macdonald HM, Nettlefold L, Bauman A, Sims-Gould J, McKay HA. Pragmatic Evaluation of Older Adults' Physical Activity in Scale-Up Studies: Is the Single-Item Measure a Reasonable Option? J Aging Phys Act. 2022 Feb 1;30(1):25-32. doi: 10.1123/japa.2020-0412. Epub 2021 Aug 4. PMID 34348228
• Simonsick EM, Newman AB, Visser M, Goodpaster B, Kritchevsky SB, Rubin S, Nevitt MC, Harris TB; Health, Aging and Body Composition Study. Mobility limitation in self-described well-functioning older adults: importance of endurance walk testing. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):841-7. doi: 10.1093/gerona/63.8.841. PMID 18772472
• Bauer GR, Braimoh J, Scheim AI, Dharma C. Transgender-inclusive measures of sex/gender for population surveys: Mixed-methods evaluation and recommendations. PLoS One. 2017 May 25;12(5):e0178043. doi: 10.1371/journal.pone.0178043. eCollection 2017. PMID 28542498
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426

Идентификаторы

NCT: NCT07696650 · H26-01517

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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