Evaluation of Choose to Move Replacement Ready (CTM-RR) (CTM-RR)
20 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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:
- 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).
- 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).
- evaluate if participant health benefits (if any) are maintained 3 months after CTM-RR is completed.
- 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.
Type d'étude
Interventionnel
Inscription (Estimé)
210
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Douglas L Race, MSc
- Numéro de téléphone: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
Sauvegarde des contacts de l'étude
- Nom: Giulia Coletta, PhD
- Numéro de téléphone: 604-875-4111
- E-mail: giulia.coletta@ubc.ca
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Recrutement
- Active Aging Research Team, Robert H. N. Ho Research Centre
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Contact:
- Douglas Race, MSc
- Numéro de téléphone: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- non-English speaking activity coach
- non-English speaking referral partner
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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Comme décrit dans la description du bras d'étude.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
Délai: 3 months
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Obtained from post-program survey.
Measures adherence to prescribed frequency, intensity, duration, and type of exercises performed, and attendance at CTM-RR group meetings.
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3 months
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Effectiveness outcome: Change in physical activity
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Satisfaction à l'égard de CTM-RR (enquête)
Délai: 3 mois
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La satisfaction à l'égard de la CTM-RR sera évaluée via un sondage des participants (adultes plus âgés) (conçue en interne).
Des scores plus élevés (1-5 échelle de Likert) indiquent une satisfaction plus élevée des participants à l'intervention.
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3 mois
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Adaptation (enquête)
Délai: 3 mois
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Des modifications planifiées ou déterminées à la livraison de CTM-RR par les entraîneurs d'activité seront évaluées par enquête (réponses à réponse courte; développé en interne).
Les entraîneurs indiqueront s'ils ont fait des adaptations au programme (oui / non) et pour fournir des détails sur des adaptations telles que la raison pour laquelle elle devait se produire.
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3 mois
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Reach
Délai: 3 months
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Number of individuals participating in CTM-RR programs will be obtained from program records
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3 months
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Retention
Délai: Baseline, 3 and 6 months, 2 weeks pre-operative
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Obtained from evaluation records.
Proportion of participants who consent to the evaluation who complete each assessment.
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Baseline, 3 and 6 months, 2 weeks pre-operative
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Dose delivered
Délai: 3 months
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Obtained from post-program survey.
Proportion of required intervention components (group meetings and one-on-one consultations) delivered by activity coaches.
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3 months
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Adoption
Délai: 3 months
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Obtained from program records.
Number of referral partners who refer participants to the program.
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3 months
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Change in walking time
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of walking
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in sedentary time
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of sedentary time
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in bone and muscle strengthening activity
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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Single-item muscle strengthening activity survey.
Number of days in past week doing activities that increase bone and muscle strength
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in balance activity
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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Single-item activity survey.
Number of days in past week doing activities that improve balance.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in capacity for mobility
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in social isolation
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in loneliness
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in ability to participate in daily activities
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in Hip disability and Osteoarthritis Outcome 12-item Score
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in Knee disability and Osteoarthritis Outcome 12-item Score
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in patient global assessment of target joint
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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).
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in arthritis-specific self-efficacy
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in pain intensity
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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Pain Numerical Rating Scale (NRS): score (0-10) assesses pain intensity on average during the past week.
Higher scores indicate worse pain intensity.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in willingness to undergo surgery
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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).
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in anxiety
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in kinesiophobia
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in exercise self-efficacy
Délai: baseline, 3 and 6 months, 2 weeks pre-operative
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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.
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baseline, 3 and 6 months, 2 weeks pre-operative
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acceptabilité - programme CTM-RR
Délai: 3 mois
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Acceptabilité de la mesure d'intervention (AIM).
La perception des entraîneurs d'activité selon laquelle CTM-RR est agréable ou satisfaisante sera évaluée par enquête (4 éléments chacun sur une échelle de Likert 1-5, 1 étant complètement en désaccord et 5 étant complètement d'accord).
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3 mois
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Propriété - Programme CTM-RR
Délai: 3 mois
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Mesure de pertinence d'intervention (IAM).
La mesure dans laquelle CTM-RR correspond aux besoins de la population cible sera évaluée par enquête (4 éléments chacun sur une échelle de Likert 1-5 avec 1 étant complètement en désaccord et 5 étant complètement d'accord)
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3 mois
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Faisabilité - programme CTM-RR
Délai: 3 mois
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Faisabilité de la mesure d'intervention (FIM).
La perception des entraîneurs d'activité selon laquelle CTM-RR est possible de livrer sera évaluée par enquête (4 éléments chacun sur une échelle de Likert 1-5 avec 1 étant complètement en désaccord et 5 étant complètement d'accord).
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3 mois
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Réactivité perçue des participants (enquête)
Délai: 3 mois
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La réactivité perçue des participants sera évaluée via un enquête participante (adultes plus âgés) (réponses à réponse courte; développé en interne).
Les personnes âgées indiqueront les composantes d'intervention facultatives dans lesquelles ils se sont engagés (enregistrement des pairs, bulletin électronique par e-mail, exercices de hanche et de genou; OUI / NON RÉPONSE)
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3 mois
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Adaptation (interview)
Délai: 3 months
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Planned or purposeful changes to the delivery of CTM-RR by activity coaches will be assessed by interview (no score associated with qualitative interview).
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3 months
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Experience with training and program delivery (interview)
Délai: 3 months
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Activity coaches overall experience with program training and delivery, will be assessed by interview (no score associated with qualitative interview).
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3 months
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Perceived participant responsiveness (interview)
Délai: 3 months
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Activity coaches' perceptions of participant responsiveness will be assessed by interview (no score associated with qualitative interview).
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3 months
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Adaptations (interview)
Délai: 3 and 6 months
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Older adults' perceptions of potential adaptations to improve the program will be assessed by interview (no score associated with qualitative interview).
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3 and 6 months
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Perceived participant responsiveness (interview)
Délai: 3 and 6 months
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Older adults' responsiveness during the program will be assessed by interview (no score associated with qualitative interview).
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3 and 6 months
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Acceptability- CTM-RR program (interview)
Délai: 3 and 6 months
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Older adults' perceptions that the program is acceptable or satisfactory will be assessed by interview (no score associated with qualitative interview).
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3 and 6 months
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Feasibility- CTM-RR program (interview)
Délai: 3 and 6 months
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Older adults' perceptions of the program's feasibility will be assessed by interview (no score associated with qualitative interview).
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3 and 6 months
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Appropriateness- CTM-RR program (interview)
Délai: 3 and 6 months
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Older adults' perceptions of the program's appropriateness will be assessed by interview (no score associated with qualitative interview).
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3 and 6 months
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Feasibility - CTM-RR referral process (interview)
Délai: 3 months
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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).
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3 months
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Acceptability - CTM-RR referral process (interview)
Délai: 3 months
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Referral partners' perception that the CTM-RR referral process is acceptable or satisfactory will be assessed by interview (no score associated with qualitative interview).
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3 months
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Appropriateness - CTM-RR referral process (interview)
Délai: 3 months
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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).
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3 months
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Sociodemographics
Délai: Baseline
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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.
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Baseline
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Surgery date
Délai: Monthly following program completion until surgery date is known (assessed up to two years).
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Determined from monthly survey sent to older adults if surgery date is not known when they complete the CTM-RR program.
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Monthly following program completion until surgery date is known (assessed up to two years).
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Heather A McKay, PhD, University of British Columbia
- Chercheur principal: Joanie Sims Gould, MSW, PhD, University of British Columbia
- Chercheur principal: Laura Churchill, PT, PhD, University of British Columbia
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
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- 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.
- 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.
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- 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.
- 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.
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- 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.
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- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 août 2028
Achèvement de l'étude (Estimé)
1 août 2028
Dates d'inscription aux études
Première soumission
30 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juillet 2026
Première publication (Réel)
10 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Arthrite
- Maladies articulaires
- Maladies rhumatismales
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Comportement social
- La douleur
- Arthrose
- Limitation de la mobilité
- Activité motrice
- Comportement sédentaire
- Isolement social
Autres numéros d'identification d'étude
- H26-01517
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .