A Randomised Pilot Study of Navigator and Coach Support for Participation in Community Activities to Promote Physical Activity and Social Contact in Persons Aged 65 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Progression decision to full trial
研究概览
简要总结
Frailty is a multidimensional syndrome in which a person accumulates age-related deficits across life domains, increasingly including social components such as social isolation. An estimated 12% of the Swiss population aged 65+ is frail and a further 46% pre-frail; without prevention, about two thirds of pre-frail persons will become frail, with major consequences for disability, hospitalisation, mortality, quality of life and health costs. Meta-analyses identify physical activity as the most promising prevention strategy, yet structured mechanisms connecting older adults with existing community activities remain underdeveloped and fragmented. To close this implementation gap, the ENGAGE implementation project co-designed a community participation support pathway with local stakeholders: older adults with low physical and/or social activity are systematically identified during routine contacts, a values-based conversation clarifies what matters to the person, the person is matched and referred to existing community activities, and a navigator (a social work professional acting as link worker) provides behavioural, practical and emotional support for initial and continued participation. Because there are uncertainties in the delivery of the study and intervention, a pilot study with a pragmatic randomised trial design is implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 years
- •Community-dwelling in Basel-Stadt/Basel-Landschaf
- •Low levels of physical activity and/or low levels of social activity or perceptions of social isolation
- •Sufficient German to understand the study information
- •Give written informed consent
排除标准
- •Residing in residential long-term care
- •Inability to move outside the home without another person's assistance (mobility aids and transport services are permitted)
- •Participation in a conflicting study
- •Severe cognitive impairment, severe psychiatric illness, communication barrier or sensory impairment precluding informed consent or meaningful engagement
研究组 & 干预措施
Navigation and support support
In intervention arm 2, patients are connected with a navigator and a coach. Navigator support in this arm will be the same as for intervention arm 1, while the coaching will be provided by a trained member of the trial team. Coaching will follow-up on the initial navigation support, and will include a more intensive behavioural support.
干预措施: Navigation support (Behavioral)
Standard of care
Participants remain free to receive usual care, professional advice, community information and community services that would normally be available outside the study.
Navigation support
In intervention arm 1, patients are connected with a navigator. The navigator is a social worker trained to conduct a needs assessment and support an older person in finding and attending an appropriate community activities/services.
干预措施: Navigation support (Behavioral)
Navigation and support support
In intervention arm 2, patients are connected with a navigator and a coach. Navigator support in this arm will be the same as for intervention arm 1, while the coaching will be provided by a trained member of the trial team. Coaching will follow-up on the initial navigation support, and will include a more intensive behavioural support.
干预措施: Coaching support (Behavioral)
结局指标
主要结局
Progression decision to full trial
时间窗: From enrollment until month 3
The primary endpoint for the pilot is the overall progression decision after the internal pilot, classified as: proceed to the full RCT without modifications; proceed with modifications; or stop.
次要结局
- Feasibility of start-up procedures(From study enrolment until randomisation at around 2 weeks)
- Number of potential participants screened, recruited, randomised and retained(From enrollment until month 3)
- Reasons for refusal, discontinuation, withdrawal or loss to follow-up(From enrollment until month 3)
- Completeness of full-trial outcome data(From enrollment until month 3)
- Parameters informing the full-trial sample-size assumptions:(From enrollment until month 3)
- Contamination between study arms(From enrollment until month 6)
- Adoption of the ENGAGE Pathway: number and percentage of approached organisations and individual deliverers reaching each adoption Stage.(From enrolment until month 3)
- Implementation-Strategy Fidelity: number and percentage of prespecified implementation strategies delivered as planned, partially delivered, or not delivered.(From enrolment until month 3)
- Implementer experience and perceptions:(From enrollment until month 3)
- Delivered dose and participant responsiveness: number and percentage of participants achieving each engagement milestone, and number and duration of navigator and coaching contacts received.(From enrollment until month 3)
- Participant experience, perceived value and determinants of participation(From enrollment until month 3)
研究者
Bastiaan Van Grootven
SNF Ambizione Fellow
University of Basel