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

Sponsor

University of British Columbia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05678985

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Active Aging Society (Other)

1,000

Enrollment

Location

Arm

51.5

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aging Mobility Limitation Sedentary Behaviour Loneliness Social Isolation Social Connectedness	Behavioral: Choose to Move	N/A

Detailed 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:

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)
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 17, 2020

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Choose to Move CTM (Phase 4) is a 3-month, flexible, choice-based program for low active older adults that can be delivered in-person or online. CTM includes One-on-One Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop an action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities. Group Meetings: Over the 3-months, participants will attend eight, 1-hour group-based meetings (up to 12 participants total) led by their activity coach. Meetings cover a discussion topic (health-related) and provide time and space for social connection between participants. Group meetings are held in person or online as public health restrictions and community preference dictate.	Behavioral: Choose to Move As described under study arm description.

Arm

Intervention/Treatment

Experimental: Choose to Move

CTM (Phase 4) is a 3-month, flexible, choice-based program for low active older adults that can be delivered in-person or online. CTM includes One-on-One Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop an action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities. Group Meetings: Over the 3-months, participants will attend eight, 1-hour group-based meetings (up to 12 participants total) led by their activity coach. Meetings cover a discussion topic (health-related) and provide time and space for social connection between participants. Group meetings are held in person or online as public health restrictions and community preference dictate.

Behavioral: Choose to Move

As described under study arm description.

Outcome Measures

Primary Outcome Measures

Change in physical activity [0, 3, 6, 15, 27-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).

Secondary Outcome Measures

Change in capacity for mobility [0, 3, 6, 15, 27-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).
Change in physical functioning [0, 3, 6, 15, 27-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.
Change in mobility [0, 3, 6, 15, 27-months]
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.
Change in loneliness [0, 3, 6, 15, 27-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.
Change in social isolation [0, 3, 6, 15, 27-months]
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.
Change in social network [0, 3, 6, 15, 27-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.
Change in social connectedness [0, 3, 6, 15, 27-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.
Change in sitting time [0, 3, 6, 15, 27-months]
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.
Change in screen time [0, 3, 6, 15, 27-months]
A single item will be used to assess screen time. The output variable is hours of screen time per day.
Change in health-related quality of life (EQ-5D-5L Profile) [0, 3, 6, 15, 27-months]
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).
Change in health-related quality of life (EQ-5D-5L Level Sum Score) [0, 3, 6, 15, 27-months]
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).
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale) [0, 3, 6, 15, 27-months]
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).

Other Outcome Measures

Reach-individual [3-months]
The number of participants engaged in the intervention will be obtained from program records.
Reach-organizational [3-months]
The number of organizations and activity coaches delivering the intervention will be obtained from program records.
Dose delivered [3-months]
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.
Fidelity (survey) [3-months]
Fidelity to planned delivery will be assessed via survey (designed in house). Higher scores indicate better adherence to planned delivery.
Fidelity (interview/focus group) [3-months]
Fidelity to planned delivery will be assessed via interview/focus group.
Participant responsiveness (survey) [3-months]
Program satisfaction will be assessed via participant survey (designed in house). Higher scores indicate higher participant satisfaction with the intervention.
Participant responsiveness (interview) [3-months]
Program satisfaction will be assessed via interview.
Adaptation (survey) [3-months]
Adaptation of the intervention and its delivery will be assessed via survey (designed in house).
Adaptation (interview/focus group) [3-months]
Adaptation of the intervention and its delivery will be assessed via interview/focus groups.
Contextual factors influencing implementation (survey) [3-months]
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).
Contextual factors influencing implementation (interview/focus group) [3-months]
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.
Cost [3-months]
Program delivery costs will be recorded using a cost capture template.
Change in Organizational Readiness (Organizational Readiness Rubric) [0, 3-months]
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.
Change in Organizational Readiness (Readiness for Organizational Change Scale) [0, 3-months]
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.
Organizational Readiness (OR) (interview/focus group) [0, 3-months]
Organizational readiness (OR) will be assessed via interview.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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