Aging Clinical Trial
Official title:
Choose to Move: How Can Health Benefits of an Effective, Scaled-up, Health Promotion Model for Older Adults be Sustained?
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.
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). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Completed |
NCT05293730 -
Trial of the Impact of the Electronic Frailty Integrated With Social Needs
|
N/A | |
Recruiting |
NCT03932162 -
Gene Expression Changes In Young and Geriatric Skin
|
Early Phase 1 | |
Completed |
NCT04064528 -
Effects of Age on Amino Acid Delivery to Tendon
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT05566938 -
Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly
|
N/A | |
Recruiting |
NCT05543980 -
Leg Heat Therapy in Elderly Individuals
|
Phase 2 | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Not yet recruiting |
NCT06071130 -
Emotion, Aging, and Decision Making
|
N/A | |
Enrolling by invitation |
NCT04641663 -
Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)
|
N/A | |
Completed |
NCT04088006 -
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
|
N/A | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05424263 -
Acetate and Age-associated Arterial Dysfunction
|
Phase 2 | |
Completed |
NCT05601713 -
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
|
N/A | |
Completed |
NCT04551339 -
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
|
N/A | |
Recruiting |
NCT04997577 -
Speech Perception and High Cognitive Demand
|
N/A | |
Completed |
NCT05922475 -
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A |