- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252259
Evaluating Implementation and Impact of the Adapted Choose to Move (CTM) Program (CTM)
Choose to Move (CTM): Implementation and Impact Evaluation of an Adapted Health-Promoting Program for Equity-Deserving Older Adults
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 Phase 5, the goal of CTM is to enhance physical activity, mobility and social connectedness in three target populations: South Asian older adults, older men, and older adults living in Northern BC. To do so, the investigators will support community-based seniors' services (CBSS) organizations through a readiness-building process so they can adapt CTM and deliver the program to these populations.
This study has two main research questions:
- How are adapted CTM programs delivered ('implementation outcomes') and what factors influence delivery ('implementation determinants')?
- What is the impact of the adapted CTM programs on health outcomes of older adults?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Phase 5, the investigators aim to expand the reach of CTM to three target populations: South Asian older adults, older men, and older adults living in Northern BC.
Within CTM (Phase 5), 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.
In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations to adapt CTM to 'best fit' these target populations of older adults, and build capacity in these organizations to deliver CTM. The investigators will then evaluate the implementation of the adapted programs, and the impact of the adapted programs on older adults' physical and social health.
Objectives:
- To assess whether CTM (Phase 5) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale (Part I - Implementation Evaluation).
- To assess the impact (effectiveness) of CTM (Phase 5) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation).
- To assess whether participant-level benefits of CTM (Phase 5) are maintained 12 months after participants complete the CTM program.
Study Design:
The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate CTM Phase 5. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline), 3 (post-intervention) and 15 (12-months post intervention) months to assess implementation and impact of CTM.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Active Aging Research Team, Robert H. N. Ho Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Central support unit staff member;
- Delivery partner organization 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;
- Punjabi-speaking older adults will also be invited to participate in the evaluation if they can read English or Punjabi and/or if the activity coach or a member of the research team has the necessary language skills to ensure effective communication of the Punjabi language translated consent form and surveys.
Exclusion criteria:
- non-English speaking delivery partner staff member
- non-English speaking activity coach
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ethnicity and Culture in Focus
CTM (Phase 5) is a 3-month, flexible, choice-based health-promoting program for low active older adults that can be delivered in-person or online. The program includes:
The CTM program will be adapted for South Asian older adults, and may include additional intervention components customized for this population. |
As described under study arm description
|
|
Experimental: Men on the Move
CTM (Phase 5) is a 3-month, flexible, choice-based health-promoting program for low active older adults that can be delivered in-person or online. The program includes:
The CTM program will be adapted for older men, and may include additional intervention components customized for this population. |
As described under study arm description
|
|
Experimental: The Forgotten North
CTM (Phase 5) is a 3-month, flexible, choice-based health-promoting program for low active older adults that can be delivered in-person or online. The program includes:
The CTM program will be adapted for older adults living in Northern BC, and may include additional intervention components customized for this population. |
As described under study arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity
Time Frame: 0, 3, 15 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).
|
0, 3, 15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in social network
Time Frame: 0, 3, 15 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.
|
0, 3, 15 months
|
|
Change in social connectedness
Time Frame: 0, 3, 15 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.
|
0, 3, 15 months
|
|
Change in health-related quality of life (EQ-5D-5L Visual Analogue Scale)
Time Frame: 0, 3, 15 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).
|
0, 3, 15 months
|
|
Change in physical activity (objective)
Time Frame: 0, 3, 15 months
|
Physical activity will be assessed by accelerometers (worn for 7 days) in a subset of participants in the Men on the Move study arm.
The output variables are minutes per day of light, moderate and vigorous physical activity.
|
0, 3, 15 months
|
|
Change in capacity for mobility
Time Frame: 0, 3, 15 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).
|
0, 3, 15 months
|
|
Change in physical functioning
Time Frame: 0, 3, 15 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.
|
0, 3, 15 months
|
|
Change in loneliness
Time Frame: 0, 3, 15 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.
|
0, 3, 15 months
|
|
Change in health-related quality of life (EQ-5D-5L Profile)
Time Frame: 0, 3, 15 months
|
The EQ-5D-5L consists of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Participants are asked to indicate their level of functioning (from 1 "no problems" to 5 "extreme problems") on each of the five dimensions of the EQ-5D-5L.
The EQ-5D-5 L describes 3125 distinct health states, with 11111 representing the best and 55555 the worst possible health states.
The investigators apply the Canadian EQ-5D-5 L scoring algorithm to generate index scores, which ranged from - 0.148 for the worst (55555) to 0.949 for the best (11111) health states.
|
0, 3, 15 months
|
|
Change in social isolation
Time Frame: 0, 3, 15 months
|
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, 15 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach-individual
Time Frame: 3 months
|
Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.
|
3 months
|
|
Reach-regional
Time Frame: 0 months
|
The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.
|
0 months
|
|
Context - CTM program (interview)
Time Frame: 3 months
|
Aspects of the larger social, political and economic environment that may influence delivery of the adapted CTM program will be assessed by interview.
|
3 months
|
|
Cost - CTM program
Time Frame: 3 months
|
Program delivery costs will be recorded using a cost capture template developed in house.
|
3 months
|
|
Culture - CTM program (interview)
Time Frame: 3 months
|
DPOs' norms, values, and basic assumptions around selected health outcomes (physical activity, mobility, social health) will be assessed by interview with DPO staff.
|
3 months
|
|
Complexity- CTM program (interview)
Time Frame: 3 months
|
Perceptions among the DPOs that the adapted CTM program is relatively difficult to understand and use; number of different intervention components will be assessed by interview with DPO staff.
|
3 months
|
|
Self-efficacy - CTM program (interview)
Time Frame: 3 months
|
DPOs belief in their own capability to execute courses of action to achieve implementation goal will be assessed by interview with DPO staff.
|
3 months
|
|
Fidelity - CTM program (interview)
Time Frame: 3 months
|
Fidelity to planned delivery will be assessed via interview with activity coaches and older adult participants.
|
3 months
|
|
Participant Responsiveness - CTM program (interview)
Time Frame: 3 months
|
Program satisfaction will be assessed via interview with older adult CTM participants.
|
3 months
|
|
Adaptation - CTM program (interview)
Time Frame: 3 months
|
Planned or purposeful changes to the delivery of the adapted CTM program by activity coaches will be assessed by interview.
|
3 months
|
|
Acceptability - CTM program (survey)
Time Frame: 3 months
|
DPOs perception that the adapted CTM program is agreeable or satisfactory will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
|
3 months
|
|
Adaptability - CTM program (survey)
Time Frame: 3 months
|
Extent to which the adapted CTM program can be adapted, tailored, refined, or reinvented to meet local needs will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
|
3 months
|
|
Feasibility - CTM program (survey)
Time Frame: 3 months
|
DPOs perception that the adapted CTM program can be successfully used within the organization will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
|
3 months
|
|
Appropriateness - CTM program (survey)
Time Frame: 3 months
|
Extent to which the adapted CTM program fits with the mission, priorities, and values of organizations or setting will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
|
3 months
|
|
Readiness (survey)
Time Frame: 0 months
|
The extent to which an organization is both willing and able to implement a particular innovation will be assessed using a modified version of the Readiness Diagnostic Scale.
This scale evaluates three components of readiness: motivation (14 items), general capacity (24 items), and innovation capacity (12 items).
Each item is scored on a 1-7 Likert scale with 1 being Strongly Disagree and 7 being Strongly Agree.
|
0 months
|
|
Adoption - CTM program
Time Frame: 3 months
|
Number of activity coaches trained to deliver the CTM program will be obtained from program records.
|
3 months
|
|
Dose delivered - CTM program (survey)
Time Frame: 3 months
|
Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).
|
3 months
|
|
Fidelity - CTM program (survey)
Time Frame: 3 months
|
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
|
|
Participant Responsiveness - CTM program (survey)
Time Frame: 3 months
|
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
|
|
Adaptation - CTM program (survey)
Time Frame: 3 months
|
Planned or purposeful changes to the delivery of the adapted CTM program by activity coaches will be assessed by survey (short answer responses; developed in house).
Coaches will indicate if they made any adaptations to the program (yes/no) and to provide details of any adaptations such as why it needed to occur.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather A McKay, PhD, University of British Columbia
- Principal Investigator: Joanie Sims Gould, PhD, University of British Columbia
- Principal Investigator: Dawn Mackey, PhD, Simon Fraser University
- Principal Investigator: Farinaz Havaei, RN, PhD, University of British Columbia
Publications and helpful links
General Publications
- Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009 Oct 19;4:67. doi: 10.1186/1748-5908-4-67.
- Xie F, Pullenayegum E, Gaebel K, Bansback N, Bryan S, Ohinmaa A, Poissant L, Johnson JA; Canadian EQ-5D-5L Valuation Study Group. A Time Trade-off-derived Value Set of the EQ-5D-5L for Canada. Med Care. 2016 Jan;54(1):98-105. doi: 10.1097/MLR.0000000000000447.
- Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.
- 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.
- Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200.
- 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.
- 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.
- Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022.
- Scaccia JP, Cook BS, Lamont A, Wandersman A, Castellow J, Katz J, Beidas RS. A practical implementation science heuristic for organizational readiness: R = MC2. J Community Psychol. 2015 Apr;43(4):484-501. doi: 10.1002/jcop.21698. Epub 2015 Apr 13.
- Miller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implement Sci. 2021 Apr 7;16(1):36. doi: 10.1186/s13012-021-01105-3.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-03385
- HG2-185013 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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