Evaluation of Choose to Move Replacement Ready (CTM-RR) (CTM-RR)
8. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
210
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Douglas L Race, MSc
- Telefonní číslo: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
Studijní záloha kontaktů
- Jméno: Giulia Coletta, PhD
- Telefonní číslo: 604-875-4111
- E-mail: giulia.coletta@ubc.ca
Studijní místa
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Active Aging Research Team, Robert H. N. Ho Research Centre
-
Kontakt:
- Douglas Race, MSc
- Telefonní číslo: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Jak je popsáno pod popis studie.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Spokojenost s CTM-RR (průzkum)
Časové okno: 3 měsíce
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Spokojenost s CTM-RR bude hodnocena prostřednictvím průzkumu účastníka (starší dospělé) (navržené v domě).
Vyšší skóre (1-5 Likertova stupnice) naznačují vyšší spokojenost účastníků s intervencí.
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3 měsíce
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Adaptace (průzkum)
Časové okno: 3 měsíce
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Plánované nebo účelné změny doručení CTM-RR pomocí trenérů činnosti budou hodnoceny průzkumem (odpovědi na krátkou odpověď; vyvinuté v domě).
Trenéři budou naznačovat, zda provedli nějaké přizpůsobení programu (ano/ne) a poskytli podrobnosti o jakýchkoli adaptacích, jako je důvod, proč k němu musí dojít.
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3 měsíce
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Reach
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).
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baseline, 3 and 6 months, 2 weeks pre-operative
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Change in anxiety
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Přijatelnost - program CTM -RR
Časové okno: 3 měsíce
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Přijatelnost intervenčního opatření (AIM).
Vnímání trenérů činnosti, že CTM-RR je příjemný nebo uspokojivý, bude hodnocen průzkumem (4 položky na 1-5 Likertově stupnici, přičemž 1 zcela nesouhlasí a 5 zcela souhlasí).
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3 měsíce
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Vhodnost - program CTM -RR
Časové okno: 3 měsíce
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Míra přiměřenosti intervence (IAM).
Rozsah, v jakém CTM-RR odpovídá potřebám cílové populace, bude hodnocen průzkumem (každý 4 položky na 1-5 Likertově stupnici, přičemž 1 je zcela nesouhlasit a 5 je zcela souhlasí)
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3 měsíce
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Proveditelnost - program CTM -RR
Časové okno: 3 měsíce
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Proveditelnost míry intervence (FIM).
Vnímání trenérů aktivity, že CTM-RR je možné doručit, bude hodnoceno průzkumem (4 položky na 1-5 Likertově stupnici, přičemž 1 zcela nesouhlasí a 5 zcela souhlasí).
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3 měsíce
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Vnímaný odezva účastníka (průzkum)
Časové okno: 3 měsíce
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Vnímaná reakce účastníka bude hodnocena prostřednictvím průzkumu účastníka (starší dospělé) (odpovědi na krátkou odpověď; vyvinuté v domě).
Starší dospělí označí, které volitelné intervenční komponenty se zabývají (peer check-in, e-mailové zpravodaj, cvičení na kyčle a kolena; ano/ne možnosti odpovědi)
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3 měsíce
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Adaptation (interview)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Heather A McKay, PhD, University of British Columbia
- Vrchní vyšetřovatel: Joanie Sims Gould, MSW, PhD, University of British Columbia
- Vrchní vyšetřovatel: Laura Churchill, PT, PhD, University of British Columbia
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
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- 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.
- 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.
- 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.
- 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.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. srpna 2028
Dokončení studie (Odhadovaný)
1. srpna 2028
Termíny zápisu do studia
První předloženo
30. června 2026
První předloženo, které splnilo kritéria kontroly kvality
8. července 2026
První zveřejněno (Aktuální)
10. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
10. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- H26-01517
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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