Implementation Science, Mobility Limitation, Osteoarthritis, Osteoarthritis, Hip, Osteoarthritis (OA) of the Knee, Pain, Physical Inactivity, Sedentary Behaviors, Social Isolation or Loneliness, Total Knee Arthroplasty; Total Hip Arthroplasty
Conditions
Keywords
Osteoarthritis, Implementation science, Social isolation, Physical activity, Mobility, Loneliness, Pain, Joint replacement, Feasibility, Acceptability, Fidelity
Brief summary
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.
Detailed description
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: 1. Assess implementation outcomes (participant recruitment, retention, dose delivered/received, fidelity) of the adapted CTM model against predetermined feasibility targets. The secondary objectives are to: 2. Describe implementation determinants (acceptability, feasibility, appropriateness) and outcomes (reach, adaptations, perceived participant responsiveness, adoption) of the adapted CTM model. 3. 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 4. 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).
Interventions
BEHAVIORALChoose to Move Replacement Ready
As described under study arm description.
Sponsors
University of British Columbia
Active Aging Society
Specialist Services Committee (Doctors of BC)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Activity coach hired by the Active Aging Society (activity coaches must speak English to participate in the evaluation); 2. English-speaking older adults (aged \>=50 years) who participate in CTM-RR will be invited to participate in the evaluation 3. Referral partner (People who work in a healthcare setting who refer patients into the program)
Exclusion criteria
1. non-English speaking activity coach 2. non-English speaking referral partner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation Outcome: Recruitment | baseline | 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. |
| Implementation Outcome: Retention | baseline, 3, 6 months | 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. |
| Implementation Outcome: Dose delivered | 3 months | 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). |
| Implementation Outcome: Dose received | 3 months | 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) |
| Implementation Outcome: Fidelity (Proportion of participants who adhered to prescribed exercise) | 3 months | 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: * on average, frequency= two sessions per week or greater * on average, intensity= 7 out of 10 rating of perceived exertion or greater * on average, duration= 20 minutes or greater * on average, exercises were completed as prescribed without omission or substitution of prescribed exercises |
| Adverse events: Number of adverse events | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity | baseline, 3, 6 months | 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) |
| Change in walking time | baseline, 3, 6 months | International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of walking (minutes per week) |
| Change in sedentary time | baseline, 3, 6 months | International Physical Activity Questionnaire (IPAQ-SF): assesses self-reported weekly minutes of sedentary time |
| Change in bone and muscle strengthening activity | baseline, 3, 6 months | Single-item muscle strengthening activity survey. Number of days in past week doing activities that increase bone and muscle strength |
| Change in balance activity | baseline, 3, 6 months | Single-item activity survey. Number of days in past week doing activities that improve balance. |
| Change in capacity for mobility | baseline, 3, 6 months | 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. |
| Change in social isolation | baseline, 3, 6 months | 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. |
| Change in loneliness | baseline, 3, 6 months | 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. |
| Change in ability to participate in daily activities | baseline, 3, 6 months | 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. |
| Change in Hip disability and Osteoarthritis Outcome 12-item Score | baseline, 3, 6 months | 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. |
| Change in Knee disability and Osteoarthritis Outcome 12-item Score | baseline, 3, 6 months | 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. |
| Change in patient global assessment of target joint | baseline, 3, 6 months | 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). |
| Change in arthritis-specific self-efficacy | baseline, 3, 6 months | 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. |
| Change in pain intensity | baseline, 3, 6 months | Pain Numerical Rating Scale (NRS): score (0-10) assesses pain intensity on average during the past week. Higher scores indicate worse pain intensity. |
| Change in willingness to undergo surgery | baseline, 3, 6 months | 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). |
| Change in anxiety | baseline, 3, 6 months | 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. |
| Change in kinesiophobia | baseline, 3, 6 months | 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. |
Countries
Canada
Contacts
CONTACTDouglas L Race, MSc
CONTACTChrista Hoy, MSc
PRINCIPAL_INVESTIGATORHeather A. McKay, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORLaura Churchill, PT, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORJoanie Sims Gould, MSW, PhD
University of British Columbia
Outcome results
None listed