Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. juli 2026 opdateret af: Heather McKay, University of British Columbia

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

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

210

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Active Aging Research Team, Robert H. N. Ho Research Centre
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Choose to Move Replacement Ready
Choose 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.
Som beskrevet under undersøgelsesarmbeskrivelsen.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
Tidsramme: 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.
3 months
Effectiveness outcome: Change in physical activity
Tidsramme: 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)

baseline, 3 and 6 months, 2 weeks pre-operative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tilfredshed med CTM-RR (undersøgelse)
Tidsramme: 3 måneder
Tilfredshed med CTM-RR vurderes via deltager (ældre voksne) undersøgelse (designet i huset). Højere score (1-5 Likert-skala) indikerer højere deltagertilfredshed med interventionen.
3 måneder
Tilpasning (undersøgelse)
Tidsramme: 3 måneder
Planlagte eller målrettede ændringer til levering af CTM-RR ved aktivitetscoaches vil blive vurderet ved undersøgelse (korte svar svar; udviklet i hus). Træner vil indikere, om de foretog tilpasninger til programmet (ja/nej) og til at give detaljer om eventuelle tilpasninger, såsom hvorfor det skulle ske.
3 måneder
Reach
Tidsramme: 3 months
Number of individuals participating in CTM-RR programs will be obtained from program records
3 months
Retention
Tidsramme: 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.
Baseline, 3 and 6 months, 2 weeks pre-operative
Dose delivered
Tidsramme: 3 months
Obtained from post-program survey. Proportion of required intervention components (group meetings and one-on-one consultations) delivered by activity coaches.
3 months
Adoption
Tidsramme: 3 months
Obtained from program records. Number of referral partners who refer participants to the program.
3 months
Change in walking time
Tidsramme: baseline, 3 and 6 months, 2 weeks pre-operative
International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of walking
baseline, 3 and 6 months, 2 weeks pre-operative
Change in sedentary time
Tidsramme: baseline, 3 and 6 months, 2 weeks pre-operative
International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of sedentary time
baseline, 3 and 6 months, 2 weeks pre-operative
Change in bone and muscle strengthening activity
Tidsramme: 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
baseline, 3 and 6 months, 2 weeks pre-operative
Change in balance activity
Tidsramme: baseline, 3 and 6 months, 2 weeks pre-operative
Single-item activity survey. Number of days in past week doing activities that improve balance.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in capacity for mobility
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in social isolation
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in loneliness
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in ability to participate in daily activities
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in Hip disability and Osteoarthritis Outcome 12-item Score
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in Knee disability and Osteoarthritis Outcome 12-item Score
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in patient global assessment of target joint
Tidsramme: 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).
baseline, 3 and 6 months, 2 weeks pre-operative
Change in arthritis-specific self-efficacy
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in pain intensity
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in willingness to undergo surgery
Tidsramme: 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).
baseline, 3 and 6 months, 2 weeks pre-operative
Change in anxiety
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in kinesiophobia
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative
Change in exercise self-efficacy
Tidsramme: 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.
baseline, 3 and 6 months, 2 weeks pre-operative

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptabilitet - CTM -RR -program
Tidsramme: 3 måneder
Acceptabilitet af interventionsforanstaltning (AIM). Aktivitetstrænernes opfattelse af, at CTM-RR er behagelig eller tilfredsstillende, vil blive vurderet ved undersøgelse (4 poster hver på en 1-5 Likert-skala, hvor 1 er helt uenig og 5 er helt enige).
3 måneder
Egnethed - CTM -RR -program
Tidsramme: 3 måneder
Interventionens passende mål (IAM). Det omfang, hvor CTM-RR passer til målpopulelsens behov, vurderes ved undersøgelse (4 poster hver på en 1-5 Likert-skala, hvor 1 er helt uenig og 5 er helt enige)
3 måneder
Feasibility - CTM -RR -program
Tidsramme: 3 måneder
Mulighed for interventionsforanstaltning (FIM). Aktivitetscoaches opfattelse af, at CTM-RR er mulig at levere, vil blive vurderet ved undersøgelse (4 poster hver på en 1-5 Likert-skala, hvor 1 er helt uenig og 5 er helt enige).
3 måneder
Oplevet deltagerens lydhørhed (undersøgelse)
Tidsramme: 3 måneder
Oplevet deltagerens lydhørhed vil blive vurderet via deltager (ældre voksne) undersøgelse (korte svar svar; udviklet i hus). Ældre voksne vil indikere, hvilke valgfri interventionskomponenter de engagerede sig i (peer check-in, e-mail-nyhedsbrev, hofte- og knæøvelser; ja/ingen svarmuligheder)
3 måneder
Adaptation (interview)
Tidsramme: 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).
3 months
Experience with training and program delivery (interview)
Tidsramme: 3 months
Activity coaches overall experience with program training and delivery, will be assessed by interview (no score associated with qualitative interview).
3 months
Perceived participant responsiveness (interview)
Tidsramme: 3 months
Activity coaches' perceptions of participant responsiveness will be assessed by interview (no score associated with qualitative interview).
3 months
Adaptations (interview)
Tidsramme: 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).
3 and 6 months
Perceived participant responsiveness (interview)
Tidsramme: 3 and 6 months
Older adults' responsiveness during the program will be assessed by interview (no score associated with qualitative interview).
3 and 6 months
Acceptability- CTM-RR program (interview)
Tidsramme: 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).
3 and 6 months
Feasibility- CTM-RR program (interview)
Tidsramme: 3 and 6 months
Older adults' perceptions of the program's feasibility will be assessed by interview (no score associated with qualitative interview).
3 and 6 months
Appropriateness- CTM-RR program (interview)
Tidsramme: 3 and 6 months
Older adults' perceptions of the program's appropriateness will be assessed by interview (no score associated with qualitative interview).
3 and 6 months
Feasibility - CTM-RR referral process (interview)
Tidsramme: 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).
3 months
Acceptability - CTM-RR referral process (interview)
Tidsramme: 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).
3 months
Appropriateness - CTM-RR referral process (interview)
Tidsramme: 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).
3 months
Sociodemographics
Tidsramme: 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.
Baseline
Surgery date
Tidsramme: 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.
Monthly following program completion until surgery date is known (assessed up to two years).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Heather A McKay, PhD, University of British Columbia
  • Ledende efterforsker: Joanie Sims Gould, MSW, PhD, University of British Columbia
  • Ledende efterforsker: Laura Churchill, PT, PhD, University of British Columbia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Vælg at flytte udskiftning klar

3
Abonner