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临床试验/NCT04592614
NCT04592614已完成不适用

Choose to Move: How Can Health Benefits of an Effective, Scaled-up, Health Promotion Model for Older Adults Be Sustained?

University of British Columbia2 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
424
试验地点
2
主要终点
Change in self-perception of mobility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in self-perception of mobility

时间窗: 0, 3, 12, 24 months

The Mobility Assessment Tool-Short Form (MAT-sf; Rejeski et al., 2015) will be used to assess change in mobility. The MAT-sf is a validated, short form video-animated tool to assess participant self-perception of mobility. Only participants with an internet connection are able to complete this measure. The output variable is a self-rated mobility score (30-80), with higher scores indicating greater self-perception of mobility. Change will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

Change in mobility limitations

时间窗: 0, 3, 12, 24 months

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 will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

Change in physical functioning

时间窗: 0, 3, 12, 24 months

Change in 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 will be assessed using longitudinal modelling across 0, 3, 12 and 24 months.

次要结局

  • Change in loneliness(0, 3, 12, 24 months)
  • Change in social isolation(0, 3, 12, 24 months)
  • Change in physical activity(0, 3, 12, 24 months)
  • Change in health status (EQ-5D-5L Level Sum Score)(0, 3, 12, 24 months)
  • Change in social connectedness(0, 3, 12, 24 months)
  • Change in health status (EQ-5D-5L Visual Analogue Scale)(0, 3, 12, 24 months)
  • Change in social network(0, 3, 12, 24 months)
  • Change in sitting time(0, 3, 12, 24 months)
  • Change in screen time(0, 3, 12, 24 months)
  • Change in health status (EQ-5D-5L Profile)(0, 3, 12, 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather McKay

Professor

University of British Columbia

研究点 (2)

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