- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07696650
Evaluation of Choose to Move Replacement Ready (CTM-RR) (CTM-RR)
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
Status
Betingelser
Intervention / Behandling
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:
- 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Douglas L Race, MSc
- Telefonnummer: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
Undersøgelse Kontakt Backup
- Navn: Giulia Coletta, PhD
- Telefonnummer: 604-875-4111
- E-mail: giulia.coletta@ubc.ca
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Active Aging Research Team, Robert H. N. Ho Research Centre
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Kontakt:
- Douglas Race, MSc
- Telefonnummer: 21787 604-875-4111
- E-mail: douglas.race@ubc.ca
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
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 |
|---|---|
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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.
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Som beskrevet under undersøgelsesarmbeskrivelsen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tilfredshed med CTM-RR (undersøgelse)
Tidsramme: 3 måneder
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Tilfredshed med CTM-RR vurderes via deltager (ældre voksne) undersøgelse (designet i huset).
Højere score (1-5 Likert-skala) indikerer højere deltagertilfredshed med interventionen.
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3 måneder
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Tilpasning (undersøgelse)
Tidsramme: 3 måneder
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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.
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3 måneder
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Reach
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptabilitet - CTM -RR -program
Tidsramme: 3 måneder
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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).
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3 måneder
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Egnethed - CTM -RR -program
Tidsramme: 3 måneder
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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)
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3 måneder
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Feasibility - CTM -RR -program
Tidsramme: 3 måneder
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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).
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3 måneder
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Oplevet deltagerens lydhørhed (undersøgelse)
Tidsramme: 3 måneder
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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)
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3 måneder
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Adaptation (interview)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
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
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H26-01517
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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
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Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
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Beijing Sport UniversityIkke rekrutterer endnu
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Future University in EgyptAfsluttet
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Camilo Jose Cela UniversityAfsluttetMyofascial Pain Syndrome (MPS)Spanien
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Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
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Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
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Turkish League Against RheumatismAtatürk University Scientific Research Projects Coordination UnitAfsluttet
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Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
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Izmir Tinaztepe UniversityEge UniversityIkke rekrutterer endnuRygliggende stilling | FLACC Skala | Behavioral Pain Scale
Kliniske forsøg med Vælg at flytte udskiftning klar
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UNICEF - VenezuelaAfsluttetSpild | Akut underernæring i barndommen | Underernæring af børnVenezuela
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Gérard AmarencoAfsluttetMultipel sclerose | Gangforstyrrelser, neurologiske | Urininkontinens, UrgeFrankrig
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University of MichiganRekrutteringSeksuel vold | Sexhandel | Børnemishandling, seksuelt | Sexforbrydelser | Kommerciel sex | SexforbrydelseForenede Stater
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Ajinomoto Co., Inc.Great Ormond Street Hospital for Children NHS Foundation Trust; Birmingham...Aktiv, ikke rekrutterende
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Institute of Tropical Medicine, BelgiumUniversity Ghent; Institut de Recherche en Sciences de la Sante, Burkina... og andre samarbejdspartnereAfsluttetModerat akut underernæringBurkina Faso
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Universidad de los Andes, ChileLiga Panamericana de Asociaciones de Reumatologia (PANLAR)Ikke rekrutterer endnu
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Washington University School of MedicineUnited States Department of Agriculture (USDA); Project Peanut Butter; Ministry... og andre samarbejdspartnereAktiv, ikke rekrutterendeFødselsdepression | For tidlig fødsel | Børns udvikling | Underernæring under graviditet | FørfødselsdepressionSierra Leone
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University of ZurichSwiss National Science Foundation; University Hospital, Basel, Switzerland og andre samarbejdspartnereAfsluttetSkrøbelighed | Sarkopeni | Efterår | Underernæring; ProteinSchweiz