Evaluating Impact and Implementation of Choose to Move (Phase 4)

Aging Clinical Trial

— CTM  

Official title:

Choose to Move (Phase 4): Impact and Implementation Evaluation of a Program to Enhance Older Adult Physical Activity, Mobility and Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05678985
• Other study ID #: H20-00780
• Secondary ID: PJT-169159
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 17, 2020
• Est. completion date: January 2025

Study information

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

Clinical Trial Summary

The objectives of this study are to: 1) evaluate whether Choose to Move (CTM) Phase 4 improves health outcomes in older adults who participate and 2) assess whether CTM Phase 4 is delivered as planned and what factors support or inhibit its delivery at scale.

CTM Phase 4 is a 3-month, choice-based program for low active older adults being scaled-up across British Columbia (BC), Canada. The goals of CTM are to enhance physical activity, mobility and social connectedness in older adults living in BC, Canada.

Description:

Choose to Move (CTM) Phase 4 is a 3-month, choice-based program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. 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. Activity coaches and recreation departments across BC are trained and provided with resources to deliver CTM.

Objectives:

1. To assess the impact (effectiveness) of CTM (Phase 4) delivered at scale on the physical activity, mobility, and social connectedness of older adults (Part I - Impact Evaluation)

2. To assess whether CTM (Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale (Part II - Implementation Evaluation).

Study Design:

The investigators use a hybrid type 2 effectiveness-implementation (Curran et al 2012) pre-post study design to evaluate CTM. The investigators use multiple methods (quantitative and qualitative) and collect data at 0 (baseline), 3 (post-intervention), 6 (3 months post-intervention), 15 (12 months post-intervention) and 27 (24 months post-intervention) months to assess impact and implementation of CTM.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria (older adults):

• =60 years of age

• demonstrate readiness for physical activity via the PAR-Q+ questionnaire, Get Active Questionnaire, or a letter of recommendation from their physician

• <150 min/week physical activity

• English speaking

• Able to connect to the Zoom or GoToMeeting platform via phone or internet in order to participate in virtual group meetings (for online programs only)

Exclusion Criteria (older adults):

• Previous participation in CTM

Inclusion Criteria (delivery partners):

• Activity coaches will be English speaking, British Columbia Recreation and Parks Association (BCRPA) registered older adult fitness leaders or kinesiologists who are delivering CTM at participating centres

• Recreation Managers and Coordinators affiliated with participating centres delivering CTM

• Provincial Partners (e.g., individuals/partners who make strategic and/or policy decisions) at partner organizations delivering Choose to Move

Activity Coach inclusion criteria:

• Able to connect to the Zoom or GoToMeeting platform via internet (video and audio required in order to see and hear participants) for online programs

• Able to connect to the Zoom or GoToMeeting platform via phone or internet in order to participate in virtual group meetings (for online programs only)

• Currently (or recently completed) participating in CTM evaluation

Related Conditions & MeSH terms

• Aging
• Loneliness
• Mobility Limitation
• Sedentary Behaviour
• Social Connectedness
• 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 (3)

Lead Sponsor	Collaborator
University of British Columbia	Active Aging Society, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. — View Citation

Holt, D.T., Armenakis, A.A., Feild, H.S., & Harris, S.G. Readiness for Organizational Change: the systematic development of a scale. The Journal of Applied Behavioral Science. 2007; 43(2): 232-255. https://doi.org/10.1177/0021886306295295

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

Lau, E. Y., Wandersman, A.H., & Pate, R. R. Factors Influencing Implementation of Youth Physical Activity Interventions: An Expert Perspective. Translational Journal of the ACSM: July 1, 2016 - Volume 1 - Issue 7 - p 60-70 doi: 10.1249/TJX.0000000000000006

Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503. — View Citation

Marshall AL, Miller YD, Burton NW, Brown WJ. Measuring total and domain-specific sitting: a study of reliability and validity. Med Sci Sports Exerc. 2010 Jun;42(6):1094-102. doi: 10.1249/MSS.0b013e3181c5ec18. — 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

Rejeski WJ, Rushing J, Guralnik JM, Ip EH, King AC, Manini TM, Marsh AP, McDermott MM, Fielding RA, Newman AB, Tudor-Locke C, Gill TM; LIFE Study Group. The MAT-sf: identifying risk for major mobility disability. J Gerontol A Biol Sci Med Sci. 2015 May;70(5):641-6. doi: 10.1093/gerona/glv003. Epub 2015 Feb 13. — 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

Vancouver Coastal Health, Fraser Health, University of British Columbia. My Health My Community Survey. 2014. https://myhealthmycommunity.org/

Veroff, J., Kulka, R. A., & Douvan, E. A. M. (1981). Mental health in America: patterns of help-seeking from, 1957 to 1976: patterns of help-seeking from 1957 to 1976. Basic Books.

Warburton, D. E., Jamnik, V. K., Bredin, S. S., & Gledhill, N. (2011). The physical activity readiness questionnaire for everyone (PAR-Q+) and electronic physical activity readiness medical examination (ePARmed-X+). The Health & Fitness Journal of Canada, 4(2), 3-17.

Ware, J. E. (1989). SF-36 health status questionnaire. Boston, MA: Institute for the Improvement of Medical Care and Health, New England Medical Center Hospital, Quality Quest Inc.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach-individual	The number of participants engaged in the intervention will be obtained from program records.	3-months
Other	Reach-organizational	The number of organizations and activity coaches delivering the intervention will be obtained from program records.	3-months
Other	Dose delivered	The amount of intervention delivered will be assessed via survey (designed in house). Lower scores indicate that a lower dose of the intervention was delivered than planned.	3-months
Other	Fidelity (survey)	Fidelity to planned delivery will be assessed via survey (designed in house). Higher scores indicate better adherence to planned delivery.	3-months
Other	Fidelity (interview/focus group)	Fidelity to planned delivery will be assessed via interview/focus group.	3-months
Other	Participant responsiveness (survey)	Program satisfaction will be assessed via participant survey (designed in house). Higher scores indicate higher participant satisfaction with the intervention.	3-months
Other	Participant responsiveness (interview)	Program satisfaction will be assessed via interview.	3-months
Other	Adaptation (survey)	Adaptation of the intervention and its delivery will be assessed via survey (designed in house).	3-months
Other	Adaptation (interview/focus group)	Adaptation of the intervention and its delivery will be assessed via interview/focus groups.	3-months
Other	Contextual factors influencing implementation (survey)	Contextual factors influencing implementation (community level factors, provider characteristics, characteristics of the innovation, the prevention delivery system, organizational capacity and the prevention support system) will be assessed via survey (designed in house).	3-months
Other	Contextual factors influencing implementation (interview/focus group)	Contextual factors influencing implementation (community level factors, provider characteristics, characteristics of the innovation, the prevention delivery system, organizational capacity and the prevention support system) will be assessed via interviews/focus groups.	3-months
Other	Cost	Program delivery costs will be recorded using a cost capture template.	3-months
Other	Change in Organizational Readiness (Organizational Readiness Rubric)	Organizational readiness (OR) will be assessed via survey (Organizational Readiness Rubric; ORR). The ORR comprises 14 items, each scored from 1-5. Higher mean scores indicate greater organizational readiness.	0, 3-months
Other	Change in Organizational Readiness (Readiness for Organizational Change Scale)	Organizational readiness (OR) will be assessed via survey (Readiness for Organizational Change Scale; ROCS). ROCS includes 25 items, each scored on a 5-point scale (1= strongly disagree to 5=strongly agree). Higher mean scores indicate greater organizational readiness for change.	0, 3-months
Other	Organizational Readiness (OR) (interview/focus group)	Organizational readiness (OR) will be assessed via interview.	0, 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, 6, 15, 27-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, 6, 15, 27-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, 6, 15, 27-months
Secondary	Change in mobility	The Mobility Assessment Tool-Short Form (MAT-sf) will be used to assess mobility. MAT-sf is a validated, short form video-animated tool to assess participant self-perception of mobility. Only participants with an internet connection are able to complete this measure. The output variable is a self-perception of mobility score (range 23.45-67.61) where a higher score indicates greater perceived mobility.	0, 3, 6, 15, 27-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, 6, 15, 27-months
Secondary	Change in social isolation	A three-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 0-15); higher scores indicate lower levels of social isolation.	0, 3, 6, 15, 27-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, 6, 15, 27-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, 6, 15, 27-months
Secondary	Change in sitting time	A five-item questionnaire will be used to assess change in sitting time (hours and minutes) each day in the following domains: (a) while travelling to and from places (e.g., work, shops); (b) while at work; (c) while watching television; (d) while using a computer at home; and (e) at leisure not including watching television (e.g., visiting friends, movies, eating out) on a weekday and a weekend day. The output variables are sitting hours per day across 5 domains.	0, 3, 6, 15, 27-months
Secondary	Change in screen time	A single item will be used to assess screen time. The output variable is hours of screen time per day.	0, 3, 6, 15, 27-months
Secondary	Change in health-related quality of life (EQ-5D-5L Profile)	Health status will be assessed using the EQ-5D-5L. Participants report on mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale from 1-5 (level of perceived problems) for each item. Responses are used to create a 5-digit number which will be used descriptively (11111 indicates no problems on any of the five dimensions whereas 55555 indicates extreme problems on all five dimensions).	0, 3, 6, 15, 27-months
Secondary	Change in health-related quality of life (EQ-5D-5L Level Sum Score)	Health status (EQ-5D-5L Level Sum Score) will be assessed with the EQ-5D-5L. Participants report on mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale from 1-5 (level of perceived problems) for each item. The Level Sum Score uses the 5-digit profile to create a numeric score, with scores ranging from 5-25 (lower levels indicate lower levels of perceived problems).	0, 3, 6, 15, 27-months
Secondary	Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)	Health status will be assessed with the EQ-5D-5L visual analogue scale. Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health).	0, 3, 6, 15, 27-months