Evaluating Impact and Implementation of Choose to Move (Phase 3) (CTM)
Primary Purpose
Aging, Physical Inactivity, Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Choose to Move
Sponsored by
About this trial
This is an interventional prevention trial for Aging focused on measuring implementation science, scale-up, behaviour change, physical activity, mobility, loneliness, social connectedness, social isolation, older adults, fidelity, adaptation
Eligibility Criteria
Inclusion Criteria (older adults):
- ≥60 years of age,
- demonstrate readiness for physical activity via the PAR-Q+ questionnaire (Warburton et al 2011), Get Active Questionnaire (Canadian Society for Exercise Physiology 2017) or a letter of recommendation from their physician
- <150 min/week physical activity
- English speaking
Exclusion Criteria (older adults):
- previous participation in CTM
Inclusion Criteria (delivery partners):
- Activity coaches will be English speaking 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
Sites / Locations
- Centre for Hip Health and Mobility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Choose to Move
Arm Description
Individuals responsible for delivering Choose to Move and older adults enrolled in Choose to Move
Outcomes
Primary Outcome Measures
Change in physical activity
The single item physical activity questionnaire will be used to measure physical activity (Milton, Bull & Bauman, 2011). Output variable is self-reported number of days/week ≥30 min PA in the past week.
Secondary Outcome Measures
Change in loneliness
The three-item loneliness scale (Hughes et al., 2004) will be used to assess change in 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
We assessed social isolation using a three-item questionnaire adapted from two questions on social contact frequency (Veroff et al 1981). The output variable is social isolation score (range 0-15); higher scores indicate less social isolation.
Change in physical functioning
Mobility will be assessed with the Physical Functioning Subscale of the 36-Item Short Form Survey (SF-36; Ware et al., 1989). The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score from 0-100 of physical functioning, where a higher score indicates a more favourable health state.
Change in physical activity (PAAQ)
The Physical Activity Adult Questionnaire will be used to assess physical activity over the previous 7 days (Garriguet et al 2015). Output variable is minutes of PA/week.
Change in health-related quality of life (EQ-5D-5L Profile)
Health status (EQ-5D-5L Profile) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). 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.
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 (The EuroQol Group, 1990). 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 (EQ-5D-5L Visual Analogue Scale) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health).
Change in mobility limitations
Two items will assess change in a participants' ability to walk a quarter of a mile and up 10 steps (Simonsick et al., 2008). The output variable is self-reported presence of mobility-disability (no/any difficulty walking 400m or climbing one flight of stairs).
Change In sitting time
A five-item questionnaire (Marshall et al., 2010) 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 social network
We use a six-item questionnaire (Lubben et al., 2006) to assess social isolation. The output variable is an equally weighted sum (range 0-30).
Change in grip strength (subset)
We assess grip strength using a hand grip dynamometer and standard protocols. We combine the best trial from each side and report the sum as total grip strength.
Change in lower extremity function (subset)
We use the short performance physical battery (SPPB) to assess lower extremity functioning (Guralnik et al 1994). The output variable is an equally weighted sum of 3 subscores (range 0-12); higher scores represent better performance.
Change in physical activity (CHAMPS)
We use the CHAMPS questionnaire (Stewart et al 2001) to assess weekly frequency and duration of a variety of physical activities and use the CHAMPS scoring algorithms to calculate energy expenditure (kcal/week) and frequency (times/week).
Full Information
NCT ID
NCT05497648
First Posted
August 5, 2022
Last Updated
August 18, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Active Aging Society
1. Study Identification
Unique Protocol Identification Number
NCT05497648
Brief Title
Evaluating Impact and Implementation of Choose to Move (Phase 3)
Acronym
CTM
Official Title
Choose to Move: 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
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
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) improves health outcomes in older adults who participate and 2) assess whether CTM is delivered as planned and what factors support or inhibit delivery at scale.
CTM is a 6 month, choice-based program for low active older adults being scaled-up across British Columbia, Canada. The goals of CTM are to enhance physical activity, mobility and social connectedness in older adults living in British Columbia, Canada.
Detailed Description
CTM is a 6 month, choice-based program for low active older adults being scaled-up in phases across British Columbia, Canada. Within CTM (phase 3), trained activity coaches support older adults in three 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 a series of group meetings with small groups of participants. Finally, activity coaches regularly check in with participants to provide ongoing support. 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 3) delivered at scale on the physical activity, mobility and social connectedness of older adults (Part I - Impact Evaluation)
To assess whether the program was implemented as planned (fidelity) and investigate factors that support or inhibit implementation at scale (Part II - Implementation Evaluation).
Study Design:
We use a hybrid type 2 effectiveness-implementation (Curran et al 2012) pre-post study design to evaluate CTM. We use mixed-methods (quantitative and qualitative) and collect data at 0 (baseline), 3 (mid-intervention), 6 (post-intervention) and 18 (12-months post-intervention) months to assess effectiveness and implementation of CTM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Physical Inactivity, Mobility Limitation, Loneliness, Social Isolation
Keywords
implementation science, scale-up, behaviour change, physical activity, mobility, loneliness, social connectedness, social isolation, older adults, fidelity, adaptation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choose to Move
Arm Type
Experimental
Arm Description
Individuals responsible for delivering Choose to Move and older adults enrolled in Choose to Move
Intervention Type
Behavioral
Intervention Name(s)
Choose to Move
Other Intervention Name(s)
CTM
Intervention Description
CTM (phase 3) is a 6-month, flexible, evidence- and choice-based program for low active older adults.
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 first three months, participants will attend five, 1-hour group-based meetings (up to 12 participants total) led by their activity coach. Meetings cover a discussion topic and provide time and space for social connection between participants.
Check-ins Over the six month program, activity coaches will provide six brief telephone check-ins (approximately 15 minutes each and once/month) to discuss their Action Plan and ask questions.
Primary Outcome Measure Information:
Title
Change in physical activity
Description
The single item physical activity questionnaire will be used to measure physical activity (Milton, Bull & Bauman, 2011). Output variable is self-reported number of days/week ≥30 min PA in the past week.
Time Frame
0, 3, 6, 18-months
Secondary Outcome Measure Information:
Title
Change in loneliness
Description
The three-item loneliness scale (Hughes et al., 2004) will be used to assess change in 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, 18-months
Title
Change in social isolation
Description
We assessed social isolation using a three-item questionnaire adapted from two questions on social contact frequency (Veroff et al 1981). The output variable is social isolation score (range 0-15); higher scores indicate less social isolation.
Time Frame
0, 3, 6, 18-months
Title
Change in physical functioning
Description
Mobility will be assessed with the Physical Functioning Subscale of the 36-Item Short Form Survey (SF-36; Ware et al., 1989). The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score from 0-100 of physical functioning, where a higher score indicates a more favourable health state.
Time Frame
0, 3, 6, 18-months
Title
Change in physical activity (PAAQ)
Description
The Physical Activity Adult Questionnaire will be used to assess physical activity over the previous 7 days (Garriguet et al 2015). Output variable is minutes of PA/week.
Time Frame
0, 3, 6, 18-months
Title
Change in health-related quality of life (EQ-5D-5L Profile)
Description
Health status (EQ-5D-5L Profile) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). 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.
Time Frame
0, 3, 6, 18-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 (The EuroQol Group, 1990). 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, 18-months
Title
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Description
health status (EQ-5D-5L Visual Analogue Scale) will be assessed with the EQ-5D-5L (The EuroQol Group, 1990). Participants report on their health on a visual analogue scale from 0 (worst health) to 100 (best health).
Time Frame
0, 3, 6, 18-months
Title
Change in mobility limitations
Description
Two items will assess change in a participants' ability to walk a quarter of a mile and up 10 steps (Simonsick et al., 2008). 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, 18-months
Title
Change In sitting time
Description
A five-item questionnaire (Marshall et al., 2010) 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, 18-months
Title
Change in social network
Description
We use a six-item questionnaire (Lubben et al., 2006) to assess social isolation. The output variable is an equally weighted sum (range 0-30).
Time Frame
0, 3, 6, 18-months
Title
Change in grip strength (subset)
Description
We assess grip strength using a hand grip dynamometer and standard protocols. We combine the best trial from each side and report the sum as total grip strength.
Time Frame
0, 3, 6, 18-months
Title
Change in lower extremity function (subset)
Description
We use the short performance physical battery (SPPB) to assess lower extremity functioning (Guralnik et al 1994). The output variable is an equally weighted sum of 3 subscores (range 0-12); higher scores represent better performance.
Time Frame
0, 3, 6, 18-months
Title
Change in physical activity (CHAMPS)
Description
We use the CHAMPS questionnaire (Stewart et al 2001) to assess weekly frequency and duration of a variety of physical activities and use the CHAMPS scoring algorithms to calculate energy expenditure (kcal/week) and frequency (times/week).
Time Frame
0, 3, 6, 18-months
Other Pre-specified Outcome Measures:
Title
Reach-individual
Description
The number of participants engaged in the intervention is obtained from program records.
Time Frame
6 months
Title
Reach-organizational
Description
The number of organizations and activity coaches delivering the intervention is obtained from program records.
Time Frame
6 months
Title
Dose
Description
The amount of intervention delivered is assessed via survey (designed in house)
Time Frame
6 months
Title
Fidelity
Description
Fidelity to planned delivery is assessed via survey (designed in house) and interview/focus group.
Time Frame
6 months
Title
Participant responsiveness
Description
We assess program satisfaction via participant survey (designed in house) and interviews.
Time Frame
6 months
Title
Adaptation
Description
We assess adaptation of the intervention and its delivery via survey (designed in house) and interview/focus groups
Time Frame
6 months
Title
Contextual factors influencing implementation
Description
We use surveys (designed in house) and interviews/focus groups to describe how community level factors, provider characteristics, characteristics of the innovation, the prevention delivery system, organizational capacity and the prevention support system influenced program delivery.
Time Frame
6 months
Title
Cost
Description
We use a cost capture template to record program delivery costs.
Time Frame
6 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 (Warburton et al 2011), Get Active Questionnaire (Canadian Society for Exercise Physiology 2017) or a letter of recommendation from their physician
<150 min/week physical activity
English speaking
Exclusion Criteria (older adults):
- previous participation in CTM
Inclusion Criteria (delivery partners):
Activity coaches will be English speaking 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather A McKay
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanie Sims Gould
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Herman, MSc
Organizational Affiliation
Ministry of Health, British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian Bauman, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn Mackey, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim Miran-Khan, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patti-Jean Naylor, PhD
Organizational Affiliation
University of Victoria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Stolee, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Hip Health and Mobility
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Citations:
Citation
Canadian Society for Exercise Physiology. Get Active Questionnaire. 2017. Available: https://csep.ca/wp-content/uploads/2021/05/GETACTIVEQUESTIONNAIRE_ENG.pdf
Results Reference
background
PubMed Identifier
22310560
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.
Results Reference
background
PubMed Identifier
18322790
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.
Results Reference
background
PubMed Identifier
10109801
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.
Results Reference
background
PubMed Identifier
26177042
Citation
Garriguet D, Tremblay S, Colley RC. Comparison of Physical Activity Adult Questionnaire results with accelerometer data. Health Rep. 2015 Jul;26(7):11-7.
Results Reference
background
PubMed Identifier
8126356
Citation
Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
Results Reference
background
PubMed Identifier
18504506
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.
Results Reference
background
PubMed Identifier
16921004
Citation
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.
Results Reference
background
PubMed Identifier
19997030
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.
Results Reference
background
PubMed Identifier
20484314
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.
Results Reference
background
PubMed Identifier
22522584
Citation
Milton K, Clemes S, Bull F. Can a single question provide an accurate measure of physical activity? Br J Sports Med. 2013 Jan;47(1):44-8. doi: 10.1136/bjsports-2011-090899. Epub 2012 Apr 20.
Results Reference
background
PubMed Identifier
18772472
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.
Results Reference
background
PubMed Identifier
11445760
Citation
Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.
Results Reference
background
Citation
Veroff, J.; Kulka, R. A.; Douvan, E. Mental health in America: Patterns of help-seeking from 1957-1976. Basic Books: New York, 1981.
Results Reference
background
Citation
Warburton DE, Jamnik VK, Bredin SSD, Gledhill N, on behalf of the PAR-Q+ Collaboration. The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Electronic Physical Activity Readiness Medical Examination (ePARmed-X+). Health & Fitness Journal of Canada. 2011;4(2):3-23.
Results Reference
background
PubMed Identifier
1593914
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.
Results Reference
background
Links:
URL
https://www.choosetomove.ca/
Description
Website for the Choose to Move Program
Learn more about this trial
Evaluating Impact and Implementation of Choose to Move (Phase 3)
We'll reach out to this number within 24 hrs