Provincial Scale-up of Choose to Move (CTM) Phase 4

Aging Clinical Trial

Official title:

Continued Evaluation of Provincial Scale-up of Choose to Move (CTM) Phase 4

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06434298
• Other study ID #: H23-02336
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 30, 2027

Study information

• Verified date: June 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess scale-up, implementation, and impact of CTM Phase 4.

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 include even more older adults living in communities 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 either in person or online.

In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations in large and small communities across BC to deliver CTM to more older adults. The investigators will then evaluate implementation of CTM programs, and the impact of the CTM program on older adults' physical and social health.

Objectives:

To assess whether CTM (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 (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 scale-up of CTM Phase 4. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5720
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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;

• Non-English speaking older adults will also be invited to participate in the evaluation as long as an intermediary who has the necessary language skills to ensure effective communication/translation of the consent and surveys is present.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aging
• Loneliness
• Mobility Limitation
• Physical Inactivity
• Social Isolation

Intervention

Behavioral:
• Choose to Move
As described under study arm description

Locations

Country	Name	City	State
Canada	Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Ministry of Health

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022. Available at: https://www150.statcan.gc.ca/n1/pub/17-20-0002/172000022022002-eng.htm

Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach-individual	Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.	3 months
Other	Reach-regional	The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.	3 months
Other	Adoption - CTM program	Number of activity coaches trained to deliver the CTM program will be obtained from program records.	3 months
Other	Dose delivered - CTM program (survey)	Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).	3 months
Other	Fidelity - CTM program (survey)	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
Other	Participant Responsiveness - CTM program (survey)	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
Other	Cost	Program delivery costs will be recorded using a cost capture template developed in house.	0, 3 months
Other	Adaptation - CTM program (survey)	Adaptations or modifications to the Choose to Move program include any additions, deletions, substitutions, repetitions, etc will be assessed by survey (developed in house).	3 months
Primary	Change in physical activity	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	Change in capacity for mobility	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
Secondary	Change in physical functioning	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
Secondary	Change in loneliness	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
Secondary	Change in social isolation	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
Secondary	Change in social network	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
Secondary	Change in social connectedness	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
Secondary	Change in bone/muscle-strengthening physical activity	A single item will be used to assess frequency (days/week) of activities that increase bone and/or muscle strength.	0, 3 months
Secondary	Change in balance-enhancing physical activity	A single item will be used to assess frequency (days/week) of activities that improve balance.	0, 3 months

External Links

•   Active Aging Research Team website
•   Choose to Move website