Evaluating Implementation and Impact of Choose to Move (Phase 5)

Aging Clinical Trial

— CTM  

Official title:

Choose to Move (Phase 5): Implementation and Impact Evaluation of a Program to Enhance Older Adult Physical and Social Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06252259
• Other study ID #: H22-03385
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: University of British Columbia
• Contact: Douglas L Race, MA
• Phone: 604-875-4111
• Email: douglas.race[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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: 1. How are adapted CTM programs delivered ('implementation outcomes') and what factors influence delivery ('implementation determinants')? 2. What is the impact of the adapted CTM programs on health outcomes of older adults?

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: 1. 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). 2. 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). 3. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 336
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Aging
• Loneliness
• Mobility Limitation
• Physical Inactivity
• Sedentary Behavior
• Social Isolation

Intervention

Behavioral:
• Choose to Move
As described under study arm description

Locations

Country	Name	City	State
Canada	Active Aging Research Team, Robert H. N. Ho Research Centre	Vancouver	British Columbia

Sponsors (4)

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

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — 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

Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022.

Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200. — View 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. — View Citation

Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009 Oct 19;4:67. doi: 10.1186/1748-5908-4-67. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach-individual	Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.	3 months
Other	Reach-regional	The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.	0 months
Other	Context - CTM program (interview)	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
Other	Acceptability - CTM program (survey)	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
Other	Adaptability - CTM program (survey)	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
Other	Feasibility - CTM program (survey)	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
Other	Appropriateness - CTM program (survey)	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
Other	Cost - CTM program	Program delivery costs will be recorded using a cost capture template developed in house.	3 months
Other	Culture - CTM program (interview)	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
Other	Complexity- CTM program (interview)	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
Other	Self-efficacy - CTM program (interview)	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
Other	Readiness (survey)	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
Other	Adoption - CTM program	Number of activity coaches trained to deliver the CTM program will be obtained from program records.	3 months
Other	Dose delivered - CTM program (survey)	Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).	3 months
Other	Fidelity - CTM program (survey)	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
Other	Fidelity - CTM program (interview)	Fidelity to planned delivery will be assessed via interview with activity coaches and older adult participants.	3 months
Other	Participant Responsiveness - CTM program (survey)	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
Other	Participant Responsiveness - CTM program (interview)	Program satisfaction will be assessed via interview with older adult CTM participants.	3 months
Other	Adaptation - CTM program (survey)	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
Other	Adaptation - CTM program (interview)	Planned or purposeful changes to the delivery of the adapted CTM program by activity coaches will be assessed by interview.	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, 15 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, 15 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, 15 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, 15 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, 15 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, 15 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, 15 months
Secondary	Change in health-related quality of life (EQ-5D-5L Profile)	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
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, 15 months
Secondary	Change in physical activity (objective)	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

External Links

•   Active Aging Research Team website
•   Choose to Move website