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

NCT07696650 — Not applicable, Recruiting, 210 participants, University of British Columbia

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Choose to Move Replacement Ready: Implementation and Effectiveness of a Virtual Health-Promoting Intervention for People Awaiting Total Hip or Knee Replacement Surgery

RegistryNCT07696650, acronym CTM-RR
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment210 (Estimated)
SponsorUniversity of British Columbia (Other); collaborators: Active Aging Society, Specialist Services Committee (Doctors of BC)
ConditionsOsteoarthritis (OA), Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee, Total Knee Anthroplasty, Total Hip Arthroplasty (THA), Mobility Limitation, Physical Activity, Older Adults, Social Isolation or Loneliness, Pain, Implementation Science, Sedentary Behaviors
InterventionsChoose to Move Replacement Ready (Behavioral)
Datesstart 2026-09-01 (estimated), primary completion 2028-08-01 (estimated), completion 2028-08-01 (estimated), first posted 2026-07-10, last updated 2026-08-24
Locations1 site in Canada

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Choose to Move Replacement ReadyExperimentalBehavioral: Choose to Move Replacement ReadyChoose to Move Replacement Ready CTM-RR is a 3-month program for individuals with hip and/or knee osteoarthritis on surgical waitlists for total hip or total knee replacement that includes three required components: 1) a 30-min one-on-one virtual consultation (via Zoom) where activity coaches support participants to set goals and develop a physical activity (PA) action plan; 2) 8 virtual group meetings (via Zoom, 90-min each) facilitated by activity coaches, with participants (10/program) who provide peer support. Each meeting includes: i) two, 15-min movement breaks where participants perform structured hip and knee exercises delivered by the coach and ii) education and discussion on relevant topics (e.g. goal setting, PA, what to expect from surgery); 3) Home-based hip and knee exercises to complete independently, 2x/week. Optional components of CTM-RR include 4) a bi-weekly newsletter distributed by the Active Aging Society and 5) peer support check-ins outside of group meetings.
  • Choose to Move Replacement Ready (Behavioral): As described under study arm description.

+Outcome measures

Primary outcomes

  • Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components) [3 months]: Obtained from post-program survey. Measures adherence to prescribed frequency, intensity, duration, and type of exercises performed, and attendance at CTM-RR group meetings.
  • Effectiveness outcome: Change in physical activity [baseline, 3 and 6 months, 2 weeks pre-operative]: Single-item physical activity questionnaire. Output measure is self-reported number of days engaging in ≥30 minutes of moderate-to-vigorous physical activity in the past week (range 0-7). Higher scores reflect a better outcome (i.e. increased physical activity)

Secondary outcomes

  • Reach [3 months]: Number of individuals participating in CTM-RR programs will be obtained from program records
  • Retention [Baseline, 3 and 6 months, 2 weeks pre-operative]: Obtained from evaluation records. Proportion of participants who consent to the evaluation who complete each assessment.
  • Dose delivered [3 months]: Obtained from post-program survey. Proportion of required intervention components (group meetings and one-on-one consultations) delivered by activity coaches.
  • Adoption [3 months]: Obtained from program records. Number of referral partners who refer participants to the program.
  • Adaptation (survey) [3 months]: Planned or purposeful changes to the delivery of CTM-RR by activity coaches will be assessed by survey (short answer responses; developed in house). Coaches will indicate if they made any adaptations to the program (yes/no) and to provide details of any adaptations such as why it needed to occur.
  • Satisfaction with CTM-RR (survey) [3 months]: Satisfaction with CTM-RR will be assessed via participant (older adults) survey (designed in house). Higher scores (1-5 Likert scale) indicate higher participant satisfaction with the intervention.
  • Change in walking time [baseline, 3 and 6 months, 2 weeks pre-operative]: International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of walking
  • Change in sedentary time [baseline, 3 and 6 months, 2 weeks pre-operative]: International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of sedentary time
  • Change in bone and muscle strengthening activity [baseline, 3 and 6 months, 2 weeks pre-operative]: Single-item muscle strengthening activity survey. Number of days in past week doing activities that increase bone and muscle strength
  • Change in balance activity [baseline, 3 and 6 months, 2 weeks pre-operative]: Single-item activity survey. Number of days in past week doing activities that improve balance.
  • Change in capacity for mobility [baseline, 3 and 6 months, 2 weeks pre-operative]: Short-Form-36 health survey (SF-36) Physical Functioning Scale: two items assess self-reported ability to walk ¼ mile and 1 flight of stairs.
  • Change in social isolation [baseline, 3 and 6 months, 2 weeks pre-operative]: Social Isolation Questionnaire: score (0-15) reflects the degree of social interaction and support. Higher scores indicate a greater level of social interaction and support.
  • Change in loneliness [baseline, 3 and 6 months, 2 weeks pre-operative]: The 3-item U.S. Health and Retirement Study Participant Lifestyle Questionnaire reflects experiences of loneliness. Each item is scored on a scale of 1-3. The output variable is the summed score of the 3 items (range 3-9); Higher scores indicate greater perceived loneliness.
  • Change in ability to participate in daily activities [baseline, 3 and 6 months, 2 weeks pre-operative]: The four-item PROMIS- Ability to Participate in Social Roles and Activities Scale- short form 4a will be used to assess perceived ability to perform one's usual social roles and activities. Each item is scored on a scale of 1-5. The output variable is the summed raw score of all 4-items (range 4-20) converted into a T-score (27.5-64.2) ; higher scores indicate greater ability to engage in social roles and activities.
  • Change in Hip disability and Osteoarthritis Outcome 12-item Score [baseline, 3 and 6 months, 2 weeks pre-operative]: The 12-item Hip Disability and Osteoarthritis Outcome Score (HOOS-12) assesses patients' hip condition (pain, function, quality of life). Each item is scored on a scale of 0-10. The output variable is the average score of the 12-items (range 0-100); higher scores indicate worse hip problems.
  • Change in Knee disability and Osteoarthritis Outcome 12-item Score [baseline, 3 and 6 months, 2 weeks pre-operative]: The 12-item Knee Disability and Osteoarthritis Outcome Score (KOOS-12) assesses patients' knee condition (pain, function, quality of life). Each item is scored on a scale of 0-10. The output variable is the average score of the 12- items (range 0-100); higher scores indicate worse knee problems.
  • Change in patient global assessment of target joint [baseline, 3 and 6 months, 2 weeks pre-operative]: Single-item measure using a numerical rating scale: score (0-10) assesses the overall condition of the affected hip or knee joint. Higher scores indicate worse condition (severe symptoms).
  • Change in arthritis-specific self-efficacy [baseline, 3 and 6 months, 2 weeks pre-operative]: The 8-item questionnaire assesses how certain an individual is that they can manage various aspects of their arthritis. Each item is scored on a scale of 1-10. The output variable is the average score of all 8-items (range 8-80); higher scores indicate more self-efficacy.
  • Change in pain intensity [baseline, 3 and 6 months, 2 weeks pre-operative]: Pain Numerical Rating Scale (NRS): score (0-10) assesses pain intensity on average during the past week. Higher scores indicate worse pain intensity.
  • Change in willingness to undergo surgery [baseline, 3 and 6 months, 2 weeks pre-operative]: One item will assess participants' willingness to undergo hip or knee replacement surgery. The question asks: "What is your current willingness to undergo a \[total hip replacement surgery or total knee replacement surgery\]?" The response options are: definitely unwilling, probably unwilling, unsure, probably willing or definitely willing. Definitely unwilling, probably unwilling, unsure= No, and probably willing or definitely willing=Yes. The output variable is self-reported willingness to undergo surgery (yes/no).
  • Change in anxiety [baseline, 3 and 6 months, 2 weeks pre-operative]: The Generalized Anxiety Disorder 7-item scale (GAD-7) will be used to assess the presence of anxiety. Each item is scored on a scale of 0-3. The output variable is the summed total of all scores (range 0-21); higher scores indicate greater levels of anxiety.
  • Change in kinesiophobia [baseline, 3 and 6 months, 2 weeks pre-operative]: The 11-item Tampa Scale for Kinesiophobia (TSK-11) assesses fear of movement in individuals with chronic pain. Each item is scored on a scale of 1-4. The output variable is the total summed score of all 11-items (range 11-44); higher scores indicate greater fear of movement.
  • Change in exercise self-efficacy [baseline, 3 and 6 months, 2 weeks pre-operative]: The 10-item Exercise Self-Efficacy Scale (ESES) assesses how confident participants are with regard to carrying out regular physical activities and exercise. Each item is scored on a scale of 1-4. The output variable is the total summed score of all 10 items (range 10-40); higher scores indicate greater self-efficacy for exercise.

Other outcomes

  • Perceived participant responsiveness (survey) [3 months]: Perceived participant responsiveness will be assessed via participant (older adults) survey ( short answer responses; developed in house). Older adults will indicate which optional intervention components they engaged in (peer check-in, e-mail newsletter, hip and knee exercises; yes/no response options)
  • Acceptability - CTM-RR program [3 months]: Acceptability of Intervention Measure (AIM). Activity coaches' perception that CTM-RR is agreeable or satisfactory will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree).
  • Appropriateness - CTM-RR program [3 months]: Intervention Appropriateness Measure (IAM). Extent to which CTM-RR fits the needs of the target population will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree)
  • Feasibility - CTM-RR program [3 months]: Feasibility of Intervention Measure (FIM). Activity coaches' perception that CTM-RR is feasible to deliver will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree).
  • Adaptation (interview) [3 months]: Planned or purposeful changes to the delivery of CTM-RR by activity coaches will be assessed by interview (no score associated with qualitative interview).
  • Experience with training and program delivery (interview) [3 months]: Activity coaches overall experience with program training and delivery, will be assessed by interview (no score associated with qualitative interview).
  • Perceived participant responsiveness (interview) [3 months]: Activity coaches' perceptions of participant responsiveness will be assessed by interview (no score associated with qualitative interview).
  • Adaptations (interview) [3 and 6 months]: Older adults' perceptions of potential adaptations to improve the program will be assessed by interview (no score associated with qualitative interview).
  • Perceived participant responsiveness (interview) [3 and 6 months]: Older adults' responsiveness during the program will be assessed by interview (no score associated with qualitative interview).
  • Acceptability- CTM-RR program (interview) [3 and 6 months]: Older adults' perceptions that the program is acceptable or satisfactory will be assessed by interview (no score associated with qualitative interview).
  • Feasibility- CTM-RR program (interview) [3 and 6 months]: Older adults' perceptions of the program's feasibility will be assessed by interview (no score associated with qualitative interview).
  • Appropriateness- CTM-RR program (interview) [3 and 6 months]: Older adults' perceptions of the program's appropriateness will be assessed by interview (no score associated with qualitative interview).
  • Feasibility - CTM-RR referral process (interview) [3 months]: Referral partners' perception that the CTM-RR referral process can be used successfully within the organization will be assessed by interview (no score associated with qualitative interview).
  • Acceptability - CTM-RR referral process (interview) [3 months]: Referral partners' perception that the CTM-RR referral process is acceptable or satisfactory will be assessed by interview (no score associated with qualitative interview).
  • Appropriateness - CTM-RR referral process (interview) [3 months]: Referral partners' perception regarding the extent to which the CTM-RR referral process fits with the mission, priorities, and values of the organization will be assessed by interview (no score associated with qualitative interview).
  • Sociodemographics [Baseline]: 22-item survey (developed in house) to capture sociodemographic characteristics of older adults including: postal code, city, age, gender, sex, height, weight, ethnicity, education level, employment status, chronic diseases, disability, living arrangement, marital status, affected joint (surgical hip or knee), other affected joints (hip/knee/spine/hands/feet), date of surgery (if known), time on waitlist, name of operating surgeon/hospital, years with hip/knee symptoms most days of the week, prior total hip/knee replacement, medication use, use of muscle strengthening exercises for their joint pain or general aerobic fitness exercise for their joint pain in the last three months, and referral source.
  • Surgery date [Monthly following program completion until surgery date is known (assessed up to two years).]: Determined from monthly survey sent to older adults if surgery date is not known when they complete the CTM-RR program.

+Eligibility

Sex: All, ages: 50 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

1. non-English speaking activity coach
2. non-English speaking referral partner

+Locations (1)

FacilityCityCountryStatus
Active Aging Research Team, Robert H. N. Ho Research CentreVancouver, British ColumbiaCanadaRecruiting

+Publications

  • 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
  • McKay H, Naylor PJ, Lau E, Gray SM, Wolfenden L, Milat A, Bauman A, Race D, Nettlefold L, Sims-Gould J. Implementation and scale-up of physical activity and behavioural nutrition interventions: an evaluation roadmap. Int J Behav Nutr Phys Act. 2019 Nov 7;16(1):102. doi: 10.1186/s12966-019-0868-4. PMID 31699095
  • Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0. PMID 18322790
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. PMID 12900694
  • Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3. PMID 11832252
  • 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
  • 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
  • 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
  • Kroll T, Kehn M, Ho PS, Groah S. The SCI Exercise Self-Efficacy Scale (ESES): development and psychometric properties. Int J Behav Nutr Phys Act. 2007 Aug 30;4:34. doi: 10.1186/1479-5868-4-34. PMID 17760999
  • 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
  • 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
  • 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
  • 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
  • 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

+Investigators

My Notes