- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06446414
Evaluating Implementation and Impact of Provincial Scale-up of the Adapted Choose to Move (CTM) Program
Provincial Scale-up of Choose to Move: Implementation and Impact Evaluation of an Adapted Health-Promoting Program for Equity-Deserving Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Choose to Move (CTM) a 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. To date (Phases 1-4), CTM participants have included mostly white older women living in large urban centres. In this project, the investigators aim to expand the reach of CTM to more diverse populations of underserved older adults across BC.
Within CTM (Phase 4), trained activity coaches support older adults in two ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate 8 group meetings with small groups of participants.
In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations across BC to adapt the CTM Phase 4 program to 'best fit' the population of underserved older adults they serve, and build capacity in these organizations to deliver CTM. The investigators will then evaluate the implementation of the adapted programs, and the impact of the adapted programs on older adults' physical and social health.
Objectives:
- To assess whether CTM (adapted Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation).
- To assess the impact (effectiveness) of CTM (adapted Phase 4) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation).
Study Design:
The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate the adapted CTM Phase 4 program. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline) and 3 (post-intervention) months to assess implementation and impact of CTM.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Active Aging Research Team, Robert H. N. Ho Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Central support unit staff member
- Activity coach hired by delivery partner organization (activity coaches must speak English to participate in the evaluation);
- English-speaking older adults (aged >=50 years) who participate in CTM (recruited by delivery partner organizations) will be invited to participate in the evaluation;
- Punjabi-speaking older adults will also be invited to participate in the evaluation if they can read English or Punjabi and/or if the activity coach or a member of the research team has the necessary language skills to ensure effective communication of the Punjabi language translated consent form and surveys.
Exclusion criteria:
- non-English speaking activity coaches
- CTM participants < 50 years
- CTM participants who do not speak either English or Punjabi
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Choose to Move
CTM (adapted Phase 4) is a 3-month, flexible, choice-based health-promoting program for low active older adults. CTM includes: 1-on-1 Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop a physical activity action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities. Group Meetings: Participants will attend eight, 1-hour group-based meetings (max of 15 participants) led by an activity coach. Meetings cover a health-related discussion topic and provide time for social connection among participants. Meetings can be held online or in-person. Community-based seniors' services organizations that deliver CTM may adapt the program (e.g., deliver in a different language, adapt for cultural or geographical factors) to fit the needs of the older adults they serve but the two components listed above will be retained. |
As described under study arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity
Time Frame: 0, 3 months
|
The single item physical activity questionnaire will be used to measure physical activity.
Output variable is self-reported number of days/week ≥30 min physical activity in the past week (range 0-7).
|
0, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in capacity for mobility
Time Frame: 0, 3 months
|
Two items will assess participants' ability to walk a quarter of a mile and up 10 steps.
The output variable is self- reported presence of mobility-disability (no/any difficulty walking 400m or climbing one flight of stairs).
|
0, 3 months
|
|
Change in physical functioning
Time Frame: 0, 3 months
|
The Physical Functioning Subscale of the SF-36 will be used to assess the physical function aspect of mobility.
The measure asks participants to rate if their health limits them in performing 10 different activities.
The output variable is an average score (range 0-100) of physical functioning, where a higher score indicates a more favourable health state.
|
0, 3 months
|
|
Change in loneliness
Time Frame: 0, 3 months
|
The three-item loneliness scale will be used to assess loneliness.
Participants rate three aspects of loneliness.
The output variable is loneliness score (range 3-9); lower scores indicate lower levels of loneliness.
|
0, 3 months
|
|
Change in social isolation
Time Frame: 0, 3 months
|
A four-item questionnaire adapted from two questions on social contact frequency will be used to assess social isolation.
The output variable is social isolation score (range 0-20); higher scores indicate lower levels of social isolation.
|
0, 3 months
|
|
Change in social network
Time Frame: 0, 3 months
|
A six-item questionnaire will be used to assess social network.
The output variable is an equally weighted sum (range 0-30) where higher scores indicate more social engagement.
|
0, 3 months
|
|
Change in social connectedness
Time Frame: 0, 3 months
|
A single item will be used to assess sense of belonging as an indicator of social connectedness.
The output variable is sense of belonging score (range 1-4) where lower scores indicate a stronger sense of belonging.
|
0, 3 months
|
|
Change in bone- and/or muscle-strengthening physical activity
Time Frame: 0, 3 months
|
A single item will be used to assess frequency (days/week) of physical activity that strengthens bone and/or muscle.
|
0, 3 months
|
|
Change in balance-enhancing physical activity
Time Frame: 0, 3 months
|
A single item will be used to assess frequency (days/week) of physical activity that improve balance.
|
0, 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach-individual
Time Frame: 3 months
|
Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.
|
3 months
|
|
Reach-regional
Time Frame: 0 months
|
The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.
|
0 months
|
|
Fidelity - CTM program (interview)
Time Frame: 3 months
|
Fidelity to planned delivery will be assessed via interview with activity coaches and older adult participants.
|
3 months
|
|
Participant Responsiveness - CTM program (interview)
Time Frame: 3 months
|
Program satisfaction will be assessed via interview with older adult CTM participants.
|
3 months
|
|
Adoption - CTM program
Time Frame: 3 months
|
Number of activity coaches trained to deliver the CTM program will be obtained from program records.
|
3 months
|
|
Dose delivered - CTM program (survey)
Time Frame: 3 months
|
Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).
|
3 months
|
|
Fidelity - CTM program (survey)
Time Frame: 3 months
|
Fidelity to planned delivery will be assessed via survey (designed in house) for activity coaches and older adult participants.
Higher scores (1-5 Likert scale) indicate better adherence to planned delivery.
|
3 months
|
|
Participant Responsiveness - CTM program (survey)
Time Frame: 3 months
|
Program satisfaction 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
|
|
Cost
Time Frame: 0, 3 months
|
Program delivery costs will be recorded using a cost capture template developed in house.
|
0, 3 months
|
|
Adaptation - CTM program (survey)
Time Frame: 3 months
|
Extent to which the adapted CTM program can be adapted, tailored, refined, or reinvented to meet local needs will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather McKay, PhD, University of British Columbia
- Principal Investigator: Joanie Sims Gould, MSW, PhD, University of British Columbia
Publications and helpful links
General Publications
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- 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.
- 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.
- 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.
- 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.
- Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009 Oct 19;4:67. doi: 10.1186/1748-5908-4-67.
- Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.
- 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.
- Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200.
- 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.
- Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022.
- Scaccia JP, Cook BS, Lamont A, Wandersman A, Castellow J, Katz J, Beidas RS. A practical implementation science heuristic for organizational readiness: R = MC2. J Community Psychol. 2015 Apr;43(4):484-501. doi: 10.1002/jcop.21698. Epub 2015 Apr 13.
- Miller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implement Sci. 2021 Apr 7;16(1):36. doi: 10.1186/s13012-021-01105-3.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H23-00199
- 2223-HQ-000373 (Other Grant/Funding Number: Public Health Agency of Canada)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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