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

Primary Purpose

Aging, Mobility Limitation, Sedentary Behaviour

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Choose to Move
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Older adults, Behaviour change, Physical inactivity, Mobility, Social connectedness, Loneliness, Effectiveness, Maintenance, Implementation, Adaptation, Acceptability, Feasibility, Fidelity, Dose

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Choose to Move

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
Change in screen time
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)
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)
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)
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).

Full Information

First Posted
December 19, 2022
Last Updated
January 6, 2023
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Active Aging Society
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1. Study Identification

Unique Protocol Identification Number
NCT05678985
Brief Title
Evaluating Impact and Implementation of Choose to Move (Phase 4)
Acronym
CTM
Official Title
Choose to Move (Phase 4): Impact and Implementation Evaluation of a Program to Enhance Older Adult Physical Activity, Mobility and Health
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Active Aging Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mobility Limitation, Sedentary Behaviour, Loneliness, Social Isolation, Social Connectedness
Keywords
Older adults, Behaviour change, Physical inactivity, Mobility, Social connectedness, Loneliness, Effectiveness, Maintenance, Implementation, Adaptation, Acceptability, Feasibility, Fidelity, Dose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Choose to Move
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Choose to Move
Intervention Description
As described under study arm description.
Primary Outcome Measure Information:
Title
Change in physical activity
Description
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).
Time Frame
0, 3, 6, 15, 27-months
Secondary Outcome Measure Information:
Title
Change in capacity for mobility
Description
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).
Time Frame
0, 3, 6, 15, 27-months
Title
Change in physical functioning
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in mobility
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in loneliness
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in social isolation
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in social network
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in social connectedness
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in sitting time
Description
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.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in screen time
Description
A single item will be used to assess screen time. The output variable is hours of screen time per day.
Time Frame
0, 3, 6, 15, 27-months
Title
Change in health-related quality of life (EQ-5D-5L Profile)
Description
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).
Time Frame
0, 3, 6, 15, 27-months
Title
Change in health-related quality of life (EQ-5D-5L Level Sum Score)
Description
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).
Time Frame
0, 3, 6, 15, 27-months
Title
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Description
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).
Time Frame
0, 3, 6, 15, 27-months
Other Pre-specified Outcome Measures:
Title
Reach-individual
Description
The number of participants engaged in the intervention will be obtained from program records.
Time Frame
3-months
Title
Reach-organizational
Description
The number of organizations and activity coaches delivering the intervention will be obtained from program records.
Time Frame
3-months
Title
Dose delivered
Description
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.
Time Frame
3-months
Title
Fidelity (survey)
Description
Fidelity to planned delivery will be assessed via survey (designed in house). Higher scores indicate better adherence to planned delivery.
Time Frame
3-months
Title
Fidelity (interview/focus group)
Description
Fidelity to planned delivery will be assessed via interview/focus group.
Time Frame
3-months
Title
Participant responsiveness (survey)
Description
Program satisfaction will be assessed via participant survey (designed in house). Higher scores indicate higher participant satisfaction with the intervention.
Time Frame
3-months
Title
Participant responsiveness (interview)
Description
Program satisfaction will be assessed via interview.
Time Frame
3-months
Title
Adaptation (survey)
Description
Adaptation of the intervention and its delivery will be assessed via survey (designed in house).
Time Frame
3-months
Title
Adaptation (interview/focus group)
Description
Adaptation of the intervention and its delivery will be assessed via interview/focus groups.
Time Frame
3-months
Title
Contextual factors influencing implementation (survey)
Description
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).
Time Frame
3-months
Title
Contextual factors influencing implementation (interview/focus group)
Description
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.
Time Frame
3-months
Title
Cost
Description
Program delivery costs will be recorded using a cost capture template.
Time Frame
3-months
Title
Change in Organizational Readiness (Organizational Readiness Rubric)
Description
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.
Time Frame
0, 3-months
Title
Change in Organizational Readiness (Readiness for Organizational Change Scale)
Description
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.
Time Frame
0, 3-months
Title
Organizational Readiness (OR) (interview/focus group)
Description
Organizational readiness (OR) will be assessed via interview.
Time Frame
0, 3-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather A McKay, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanie Sims Gould, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Evaluating Impact and Implementation of Choose to Move (Phase 4)

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