Clinical trial NCT06446414: Evaluating Implementation and Impact of Provincial Scale-up of the Adapted Choose to Move (CTM) Program
Official title: Provincial Scale-up of Choose to Move: Implementation and Impact Evaluation of an Adapted Health-Promoting Program for Equity-Deserving Older Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aging
Mobility Limitation
Physical Inactivity
Loneliness
Social Isolation
Keywords: Older adults
Physical activity
Mobility
Social isolation
Loneliness
Social connectedness
Behavior change
Implementation
Adaptation
Scale-up
Health equity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2024-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. In this project, the investigators will support community-based seniors' services (CBSS) organizations across BC through a readiness-building process so they can adapt CTM and deliver the program to more diverse groups of underserved older adults than have previously participated in CTM.

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:

1. 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).
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in physical activity
timeFrame: 0, 3 months
Secondary outcomes:
measure: Change in capacity for mobility
timeFrame: 0, 3 months
measure: Change in physical functioning
timeFrame: 0, 3 months
measure: Change in loneliness
timeFrame: 0, 3 months
measure: Change in social isolation
timeFrame: 0, 3 months
measure: Change in social network
timeFrame: 0, 3 months
measure: Change in social connectedness
timeFrame: 0, 3 months
measure: Change in bone- and/or muscle-strengthening physical activity
timeFrame: 0, 3 months
measure: Change in balance-enhancing physical activity
timeFrame: 0, 3 months
Other outcomes:
measure: Reach-individual
timeFrame: 3 months
measure: Reach-regional
timeFrame: 0 months
measure: Adoption - CTM program
timeFrame: 3 months
measure: Dose delivered - CTM program (survey)
timeFrame: 3 months
measure: Fidelity - CTM program (survey)
timeFrame: 3 months
measure: Fidelity - CTM program (interview)
timeFrame: 3 months
measure: Participant Responsiveness - CTM program (survey)
timeFrame: 3 months
measure: Participant Responsiveness - CTM program (interview)
timeFrame: 3 months
measure: Cost
timeFrame: 0, 3 months
measure: Adaptation - CTM program (survey)
timeFrame: 3 months
Locations:
city: Vancouver
country: Canada
facility: Active Aging Research Team, Robert H. N. Ho Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Heather McKay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Joanie Sims Gould, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009 Oct 19;4:67. doi: 10.1186/1748-5908-4-67.
citation: Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022.
citation: 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.
citation: 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.
citation: 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.