Clinical trial NCT04592614: Choose to Move - Next Steps: Can 'Booster Sessions' Sustain Health Benefits of an Effective, Scaled-up, Health Promotion Program?
Official title: Choose to Move: How Can Health Benefits of an Effective, Scaled-up, Health Promotion Model for Older Adults be Sustained?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Mobility Limitation
Sedentary Behavior
Loneliness
Social Isolation
Keywords: Physical Inactivity
Sustainability
Maintenance
Behaviour Change
Physical Activity
Implementation Science
Scale-up
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Active Aging Society
First posted: 2020-10-19
Enrollment: 424
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel assignment intervention model.

Consenting participants (older adults and activity coaches) will be randomly assigned (at the level of their CTM group) to one of two CTM-NS study arms: 1) monthly virtual group meetings (high dose), or 2) quarterly virtual group meetings (low dose). Randomization is not relevant for provincial partners and coordinators.
Primary purpose: PREVENTION

Brief summary: One-third of Canadians will be older adults (\>65y) by 2050. Thus, healthy aging is a public health priority. Many older adult health promoting interventions have been implemented, yet few were scaled-up and sustained. Choose to Move (CTM) is an effective, adaptable, community-based health promotion program for older adults. CTM, co-created with government and community stakeholders, has been scaled-up across British Columbia (BC) using a phased approach (2015-2021). The investigators evaluated the impact of CTM on the health of seniors who participated and the results were extremely positive: CTM increased mobility, physical activity, social connectedness and improved mental health indicators like loneliness. When these outcomes were assessed again, one year after the end of CTM, these improvements had diminished.

In this trial the investigators aim to determine if health benefits of CTM can be maintained by providing ongoing support to CTM participants. Booster interventions have been defined as "brief contacts beyond the main part of the intervention to reinforce previous intervention content" (Fjeldsoe et al., 2011, p. 601). Choose to Move - Next Steps (CTM-NS) is a two-year intervention where participants who recently completed CTM will receive different doses of a 'booster' program. Specifically, participants will be randomly allocated to virtual group meetings on a monthly (study arm 1; high dose) or quarterly (study arm 2; low dose) basis. Group meetings will be facilitated by an Activity Coach.

Objectives:

The investigators will conduct 1) impact, 2) implementation, and 3) economic evaluations of CTM-NS across 24 months.

Hypotheses:

For objective 1, the investigators hypothesize that improvements in older adult participant outcomes (primary outcome: mobility; secondary outcomes: physical activity, loneliness, social isolation, social connectedness, sitting time, screen time, social network, health status) obtained during CTM will be maintained over the 2 year CTM-NS study. Participants in the monthly group meetings (study arm 1) will maintain benefits to a greater degree than participants in the quarterly group meetings (study arm 2). Objectives 2 and 3 are descriptive and therefore have no hypotheses.

Detailed description: Study Design

The investigators will use a type 2 hybrid effectiveness-implementation study design. CTM participants who choose to enrol in CTM-NS will be randomly assigned to one of two CTM-NS booster intervention arms: high dose (monthly meetings) or low dose (quarterly meetings).

Participants and Recruitment

There are 4 participant groups in this study:

1. Provincial partners. These are individuals who make strategic and policy decisions for their organization. Provincial partners will be invited to participate in the study through written invitation and consent form delivered via email from a member of the research team. These individuals will be asked to respond to the invite and confirm or decline participation.
2. Provincial coordinators. These individuals coordinate and oversee delivery of programs within delivery partner organizations. Provincial coordinators will be invited to participate in the study through written invitation and consent form delivered via email from a member of the research team. They will be asked to respond to the invite and confirm or decline participation.
3. Activity Coaches. Activity Coaches are hired and contracted by delivery partners to deliver CTM-NS. They will be informed of the evaluation and invited to participate during hiring and training.
4. Older adults. CTM evaluation participants who have recently completed CTM will be invited to participate in CTM-NS.

Intervention and Randomization

Participants will be randomized (along with any other participants from the same CTM group) by a member of the research team to one of two CTM-NS study arms. The sustainability portion of the intervention will be 24 months and consist of monthly (study arm 1; high dose) or quarterly (study arm 2; low dose) group meetings delivered remotely via the Zoom or GoToMeeting platform (password protected; access through phone or internet). Group meetings (1-hr each) of 6-11 older adults will be facilitated by a trained Activity Coach. Older adults will have the option to sign up for a bi-weekly CTM electronic newsletter containing health information and ideas and resources for older adults to be physically active and socially connected at home (and elsewhere as local restrictions permit). Within each group, Activity Coaches will also facilitate social connections between participants to encourage contact (by phone or online) outside of group sessions (for interested participants only). Groups will be combined as needed to achieve and maintain targeted group sizes. The CTM-NS intervention is only open to older adults who participated in the CTM evaluation.

Timeline

CTM will be delivered in 2 cycles:

1. CTM Fall 2020 cycle with program start dates approximately Sept-Oct 2020;
2. CTM Winter 2021 cycle with program start dates approximately Jan-Feb 2021.

Corresponding CTM-NS program start dates are approximately Jan-Feb 2021 (for Fall 2020 CTM programs) and April-May 2021 (for Winter 2021 CTM programs).

CTM-NS Evaluation

The investigators will use a type 2 hybrid effectiveness-implementation study design and mixed (qualitative and quantitative) methods to address the research objectives.

Participant groups will be evaluated as follows:

1. Provincial partners will be interviewed at 12 and 24 months after the start of the first CTM-NS program. In this group the investigators assess: adaptation; innovation characteristics; community context (facilitators and barriers to implementation; sustainability of delivery).
2. Provincial coordinators will be interviewed at 12 and 24 months after the start of the first CTM-NS program. In this group the investigators assess: reach; adaptation; community context (facilitators and barriers to implementation, sustainability of delivery); innovation characteristics; prevention support system; economic evaluation (costs associated with delivering CTM-NS).
3. Activity Coaches will provide survey data at 3, 12, and 24 months of each CTM-NS program they deliver. A subset of Activity Coaches (n=20) will be interviewed at 3, 12, and 24 months. In this group the investigators assess: dose delivered; quality; participant responsiveness; adaptation; provider characteristics; innovation characteristics; community context (facilitators and barriers to implementation); prevention support system.
4. Older adults will provide survey data at 0, 3, 12, and 24 months of their CTM-NS program. A subset of older adults (n=20) will be interviewed at 3, 12, and 24 months. In this group the investigators assess: reach (participant characteristics); dose received; participant responsiveness (satisfaction, engagement, enjoyment); quality; impact of CTM-NS on participant-level outcomes; how contextual factors influence program engagement and participant-level outcomes. Thus, participants will provide data at 4 time points in total: 0 (baseline for CTM-NS), 3, 12 and 24 months. Participants' baseline data from the main CTM study will be used in combination with these data to assess sustainability of outcomes (post-CTM is equivalent to baseline CTM-NS).

Eligibility criteria: Inclusion Criteria:

* Provincial partners inclusion criteria: These are individuals who make strategic and policy decisions for their organization
* Provincial coordinators inclusion criteria: These individuals coordinate and oversee delivery of programs within our delivery partner organizations.
* Activity Coach inclusion criteria: Completed CTM training and 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
* Older adult inclusion criteria: English speaking, age ≥60 yrs, self-described as engaging in \<150 min of moderate-to-vigorous physical activity per week and demonstrated readiness for physical activity (by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), Get Active Questionnaire or a letter of recommendation from their physician) before joining CTM, 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

Exclusion Criteria:

* Provincial partners, provincial coordinators and Activity Coach exclusion criteria: None
* Older adult exclusion criteria: Non-English speaking, Unable to connect to the Zoom or GoToMeeting platform via phone or internet in order to participate in virtual group meetings

Primary outcomes:
measure: Change in mobility limitations
timeFrame: 0, 3, 12, 24 months
measure: Change in physical functioning
timeFrame: 0, 3, 12, 24 months
measure: Change in self-perception of mobility
timeFrame: 0, 3, 12, 24 months
Secondary outcomes:
measure: Change in physical activity
timeFrame: 0, 3, 12, 24 months
measure: Change in loneliness
timeFrame: 0, 3, 12, 24 months
measure: Change in social isolation
timeFrame: 0, 3, 12, 24 months
measure: Change in social connectedness
timeFrame: 0, 3, 12, 24 months
measure: Change in sitting time
timeFrame: 0, 3, 12, 24 months
measure: Change in screen time
timeFrame: 0, 3, 12, 24 months
measure: Change in social network
timeFrame: 0, 3, 12, 24 months
measure: Change in health status (EQ-5D-5L Profile)
timeFrame: 0, 3, 12, 24 months
measure: Change in health status (EQ-5D-5L Level Sum Score)
timeFrame: 0, 3, 12, 24 months
measure: Change in health status (EQ-5D-5L Visual Analogue Scale)
timeFrame: 0, 3, 12, 24 months
Other outcomes:
measure: Reach - Individual
timeFrame: 24 months
measure: Reach - Organizational
timeFrame: 24 months
measure: Dose delivered (Intervention Components)
timeFrame: 24 months
measure: Dose delivered (Implementation Strategies)
timeFrame: 24 months
measure: Dose received
timeFrame: 24 months
measure: Quality
timeFrame: 24 months
measure: Participant responsiveness
timeFrame: 24 months
measure: Adaptation (survey)
timeFrame: 24 months
measure: Adaptation (interviews)
timeFrame: 24 months
measure: Community context (survey)
timeFrame: 24 months
measure: Community context (interviews)
timeFrame: 24 months
measure: Provider characteristics (interviews)
timeFrame: 24 months
measure: Innovation characteristics (Acceptability)
timeFrame: 24 months
measure: Innovation characteristics (Feasibility)
timeFrame: 24 months
measure: Innovation characteristics (Appropriateness)
timeFrame: 24 months
measure: Innovation characteristics (survey)
timeFrame: 24 months
measure: Innovation characteristics (interviews)
timeFrame: 24 months
measure: Prevention support system (survey)
timeFrame: 24 months
measure: Prevention support system (interviews)
timeFrame: 24 months
measure: Direct intervention delivery costs
timeFrame: 24 months
measure: Value
timeFrame: 24 months
Locations:
city: Vancouver
country: Canada
facility: Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Heather A McKay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Joanie Sims-Gould, PhD
role: PRINCIPAL_INVESTIGATOR
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