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| Name | Class |
|---|---|
| Active Aging Society | OTHER |
| Specialist Services Committee (Doctors of BC) | UNKNOWN |
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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 goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR.
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.
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. Trained activity coaches hired by the Active Aging Society will deliver CTM-RR to individuals on surgical waitlists for TKR/THR. The investigators will then evaluate implementation of CTM-RR, and the impact of CTM-RR on participants' physical and social health.
The primary objective of this trial is to:
Assess implementation outcomes (participant recruitment, retention, dose delivered/received, fidelity) of the adapted CTM model against predetermined feasibility targets.
The secondary objectives are to:
Describe implementation determinants (acceptability, feasibility, appropriateness) and outcomes (reach, adaptations, perceived participant responsiveness, adoption) of the adapted CTM model.
Evaluate the preliminary estimates of effectiveness of CTM-RR. Specifically, whether CTM-RR increases participants' pre-operative moderate-to-vigorous physical activity, light physical activity, mobility, psychosocial health, and self-efficacy to manage their condition; improves their perception of their joint condition, function, and quality of life; and decreases pain, social isolation, loneliness, and sedentary time
Assess whether participant-level health benefits, if any, are maintained 3 months after participants complete the CTM-RR program.
In partnership with the Active Aging Society, the investigators aim to deliver 6 CTM-RR online programs over 9-months to approximately 60 participants total 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 will conduct a feasibility trial using a hybrid implementation-effectiveness type 2 trial design. Data will be collected at 0 (baseline), 3 (post-intervention), and 6 (long-term follow-up) months to assess implementation and impact of CTM-RR, and maintenance of any program-related benefits. The investigators will also collect physical activity logs from program participants (weekly, during program participation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choose to Move Replacement Ready | Experimental | 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 PA action plan; 2) 8 virtual group meetings (via Zoom, 90-min each) facilitated by activity coaches, with small groups of 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 AAS and 5) peer support check-ins outside of group meetings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choose to Move Replacement Ready | Behavioral | As described under study arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implementation Outcome: Recruitment | Obtained from program records. Proportion of people who attend the program information session, are eligible, and enrol in the program. Feasibility Target: Enrol 50% of people attending the program information session who are eligible to participate to the program. | baseline |
| Implementation Outcome: Retention | Obtained from evaluation records. Proportion of participants who consent to the evaluation who complete each follow-up assessment. Feasibility target: A minimum of 80% of participants who consented to the evaluation (and are in the pre-operative period) completing each follow-up assessment. | baseline, 3, 6 months |
| Implementation Outcome: Dose delivered | Obtained from post-program survey. Proportion of required intervention components (group meetings and one-on-one consultations) delivered by activity coaches. Feasibility target: Activity coaches delivering 90% of required intervention components (group meetings and one-on-one consultations). | 3 months |
| Implementation Outcome: Dose received | Obtained from post-program survey. Proportion of participants who consent to the evaluation, attending required intervention components (group meetings and one-on-one consultation) Feasibility target: Participants who consent to the evaluation attending 6 out of 9 (>60%) of required intervention components (group meetings and one-on-one consultation) | 3 months |
| Implementation Outcome: Fidelity (Proportion of participants who adhered to prescribed exercise) | Obtained from post-program survey. Measures adherence to prescribed frequency, intensity, duration, and type of exercises performed. 80% of participants adhered to all of the following criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | 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, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability - CTM-RR program | Acceptability of Intervention Measure (AIM). Activity coaches' perception that CTM-RR is agreeable or satisfactory will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree). | 3 months |
| Appropriateness - CTM-RR program |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas L Race, MSc | Contact | 604-875-4111' | 21787 | douglas.race@ubc.ca |
| Christa Hoy, MSc | Contact | 604-675-2581 | christa.hoy@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Heather A. McKay, PhD | University of British Columbia | Principal Investigator |
| Laura Churchill, PT, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Active Aging Research Team, Robert H. N. Ho Research Centre | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23221356 | Background | 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. | |
| 12777182 | Background | 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. |
| Label | URL |
|---|---|
| Choose to Move website | View source |
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| 3 months |
| Adverse events: Number of adverse events | Obtained from post-program survey. Number of adverse events related to Choose to Move: Replacement Ready that required medical treatment and/or lasted two or more days. | 3 months |
| Change in walking time |
International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of walking (minutes per week) |
| baseline, 3, 6 months |
| Change in sedentary time | International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of sedentary time | baseline, 3, 6 months |
| Change in bone and muscle strengthening activity | Single-item muscle strengthening activity survey. Number of days in past week doing activities that increase bone and muscle strength | baseline, 3, 6 months |
| Change in balance activity | Single-item activity survey. Number of days in past week doing activities that improve balance. | baseline, 3, 6 months |
| Change in capacity for mobility | Short-Form-36 health survey (SF-36) Physical Functioning Scale: two items assess self-reported ability to walk ¼ mile and 1 flight of stairs. | baseline, 3, 6 months |
| Change in social isolation | Social Isolation Questionnaire: score (0-15) reflects the degree of social interaction and support. Higher scores indicate a greater level of social interaction and support. | baseline, 3, 6 months |
| Change in loneliness | The 3-item U.S. Health and Retirement Study Participant Lifestyle Questionnaire reflects experiences of loneliness. Each item is scored on a scale of 1-3. The output variable is the summed score of the 3 items (range 3-9); Higher scores indicate greater perceived loneliness. | baseline, 3, 6 months |
| Change in ability to participate in daily activities | The four-item PROMIS- Ability to Participate in Social Roles and Activities Scale- short form 4a will be used to assess perceived ability to perform one's usual social roles and activities. Each item is scored on a scale of 1-5. The output variable is the summed raw score of all 4-items (range 4-20) converted into a T-score (27.5-64.2) ; higher scores indicate greater ability to engage in social roles and activities. | baseline, 3, 6 months |
| Change in Hip disability and Osteoarthritis Outcome 12-item Score | The 12-item Hip Disability and Osteoarthritis Outcome Score (HOOS-12) assesses patients' hip condition (pain, function, quality of life). Each item is scored on a scale of 0-10. The output variable is the average score of the 12-items (range 0-100); higher scores indicate worse hip problems. | baseline, 3, 6 months |
| Change in Knee disability and Osteoarthritis Outcome 12-item Score | The 12-item Knee Disability and Osteoarthritis Outcome Score (KOOS-12) assesses patients' knee condition (pain, function, quality of life). Each item is scored on a scale of 0-10. The output variable is the average score of the 12-items (range 0-100); higher scores indicate worse knee problems. | baseline, 3, 6 months |
| Change in patient global assessment of target joint | Single-item measure using a numerical rating scale: score (0-10) assesses the overall condition of the affected hip or knee joint. Higher scores indicate worse condition (severe symptoms). | baseline, 3, 6 months |
| Change in arthritis-specific self-efficacy | The 8-item questionnaire assesses how certain an individual is that they can manage various aspects of their arthritis. Each item is scored on a scale of 1-10. The output variable is the average score of all 8-items (range 8-80); higher scores indicate more self-efficacy. | baseline, 3, 6 months |
| Change in pain intensity | Pain Numerical Rating Scale (NRS): score (0-10) assesses pain intensity on average during the past week. Higher scores indicate worse pain intensity. | baseline, 3, 6 months |
| Change in willingness to undergo surgery | One item will assess participants' willingness to undergo hip or knee replacement surgery. The question asks: "What is your current willingness to undergo a [total hip replacement surgery or total knee replacement surgery]?" The response options are: definitely unwilling, probably unwilling, unsure, probably willing or definitely willing. Definitely unwilling, probably unwilling, unsure= No, and probably willing or definitely willing=Yes. The output variable is self-reported willingness to undergo surgery (yes/no). | baseline, 3, 6 months |
| Change in anxiety | The Generalized Anxiety Disorder 7-item scale (GAD-7) will be used to assess the presence of anxiety. Each item is scored on a scale of 0-3. The output variable is the summed total of all scores (range 0-21); higher scores indicate greater levels of anxiety. | baseline, 3, 6 months |
| Change in kinesiophobia | The 11-item Tampa Scale for Kinesiophobia (TSK-11) assesses fear of movement in individuals with chronic pain. Each item is scored on a scale of 1-4. The output variable is the total summed score of all 11-items (range 11-44); higher scores indicate greater fear of movement. | baseline, 3, 6 months |
Intervention Appropriateness Measure (IAM). Extent to which CTM-RR fits the needs of the target population will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree) |
| 3 months |
| Feasibility - CTM-RR program | Feasibility of Intervention Measure (FIM). Activity coaches' perception that CTM-RR is feasible to deliver will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree). | 3 months |
| Reach | Number of individuals participating in CTM-RR programs will be obtained from program records. | 3 months |
| Adoption | Obtained from program records. Number of referral partners who refer participants to the program. | baseline |
| Satisfaction with CTM-RR (survey) | Satisfaction with CTM-RR will be assessed via participant (older adults) survey (designed in house). Higher scores (1-5 Likert scale) indicate higher participant satisfaction with the intervention. | 3 months |
| Perceived participant responsiveness (survey) | Perceived participant responsiveness will be assessed via participant (older adults) survey ( short answer responses; developed in house). Older adults will indicate which optional intervention components they engaged in (peer check-in, e-mail newsletter, hip and knee exercises; yes/no response options) | 3 months |
| Adaptation (survey) | Planned or purposeful changes to the delivery of CTM-RR by activity coaches will be assessed by survey (short answer responses; developed in house). Coaches will indicate if they made any adaptations to the program (yes/no) and to provide details of any adaptations such as why it needed to occur. | 3 months |
| Perceived participant responsiveness (survey) | Perceived participant responsiveness will be assessed via participant (activity coach) survey (developed in house). Activity coaches will indicate whether participants were interactive, enthusiastic, interested, and engaged during group meetings. | 3 months |
| Adaptation (interview) | Planned or purposeful changes to the delivery of CTM-RR by activity coaches will be assessed by interview. | 3 months |
| Experience with training and program delivery (interview) | Activity coaches overall experience with program training and delivery, will be assessed by interview | 3 months |
| Perceived participant responsiveness (interview) | Activity coaches perceptions of participant responsiveness will be assessed by interview. | 3 months |
| Adaptations (interview) | Older adults' perceptions of potential adaptations to improve the program will be assessed by interview | 3 months |
| Perceived participant responsiveness (interview) | Older adults' responsiveness during the program will be assessed by interview. | 3 months |
| Acceptability- CTM-RR program (interview) | Older adults' perceptions that the program is acceptable or satisfactory will be assessed by interview. | 3 months |
| Feasibility- CTM-RR program (interview) | Older adults' perceptions of the program's feasibility will be assessed by interview. | 3 months |
| Appropriateness- CTM-RR program (interview) | Older adults' perceptions of the program's appropriateness will be assessed by interview. | 3 months |
| Feasibility - CTM-RR referral process (interview) | Referral partners' perception that the CTM-RR referral process can be used successfully within the organization will be assessed by interview. | 3 months |
| Acceptability - CTM-RR referral process (interview) | Referral partners' perception that the CTM-RR referral process is acceptable or satisfactory will be assessed by interview. | 3 months |
| Appropriateness - CTM-RR referral process (interview) | 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. | 3 months |
| Physical activity goal setting | At the start of the program, older adult participants complete an Action Plan with support from their activity coach. They record a physical activity goal that is specific, measurable, attainable, relevant, and time-based (SMART). Action Plans will be collected and information from the Action Plans will be reported descriptively. | baseline |
| Self-reported physical activity participation | Older adult participants will record the type and duration of physical activities they engaged in over the past 7 days on a weekly basis during CTM-RR. Data will be reported descriptively. | Weekly (from baseline to 3 months) |
| Joanie Sims Gould, MSW, PhD |
| University of British Columbia |
| Principal Investigator |
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| Active Aging Research Team website | View source |
| Aging Aging Society website | View source |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D015207 | Osteoarthritis, Hip |
| D051346 | Mobility Limitation |
| D012934 | Social Isolation |
| D010146 | Pain |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
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