跳至主要内容
临床试验/NCT05849870
NCT05849870撤回不适用

Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study

Aberystwyth University1 个研究点 分布在 1 个国家开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Frequency of health care use

研究概览

简要总结

Primary Care General Practitioners (GPs) are always looking at ways to improve the care of older people and ways to prevent older people from losing their independence. Pro-active provision of support often involves lifestyle advice and is a potentially important aspect of that, as it supports older people before acute care is needed. It's preventative caring, rather than reactive caring. But, implementing pro-active care is hampered by the high current workload of acute care, the uncertainty of 'what works' and whether patients are responsive to pro-active care plans. This project will explore different ways of providing pro-active support to older people who could be at risk of losing their independence and requiring frequent acute care. The benefits of pro-active care are arguably the greatest in these individuals.

详细描述

This is randomised control trial design with a cluster randomisation, whereby each cluster (a GP surgery) will have a different intervention. As it's a feasibility study, there will only be one cluster per intervention.

Participants will be recruited from 4 local primary care surgeries, and if participants take part, they will have 4 visits, and will be randomly allocation of an intervention arm, or a control arm receiving usual care.

At the start, the participant would have 2 visits of a maximum of 2 hours to the participant's local GP surgery to undergo a variety of tasks and assessments about the participant's well-being, health and physical functioning. That could lead to an 'action plan' that is implemented. The participant will have the 3rd visit after 3 months, and a final (fourth) visit after 12 months. During the 3rd and 4th visit the participant will repeat various tasks and assessments done in visit 1 and 2.

The project comprises different activities in the different GP surgeries. The project compares different approaches that each surgery takes. Generally, each surgery will assess relevant aspects that are associated with 'getting older' and provide support in the coming months. The specific approaches are based on the Comprehensive Geriatric Assessment, the World Health Organisation's recommendation and resources for the Integrated Care of Older People (ICOPE) model, the recommendations from the International Conference of Frailty and Sarcopenia Research (ICFSR) and the Functional Fitness test battery. All of these approaches would lead to an 'personal care plan' developed by the medical student, with actions that are specific to the participant's circumstances.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

There will be different people assigned to the delivery and the intervention. The effectiveness of this will be established as part of the feasibility evaluation.

入排标准

年龄范围
60 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The study focuses on community-dwelling frail older people (≥ 60 years). Each GP surgery will complete the electronic Frailty Index (eFI) to stratify older people based on their level of frailty (non-frail, mildly frail, and frail). Participants will be stratified into four strata,
  • •participants without complex care needs and with a relatively low frailty level (non-frail);
  • •participants with some chronic conditions that could put them at risk in the future (mild frailty)
  • •frail participants at risk of complex care needs (frailty)
  • •participants with complex care needs (severe frailty).
  • •Inclusion Criteria:
  • •adults aged 60 years or older
  • •mild frailty or frailty based on the eFI,
  • •without severe cognitive impairment diagnoses,
  • •not currently taking part in other research or in the previous 6 months,
  • •willing to provide informed consent

排除标准

  • •are terminally ill
  • •have severe cognitive or psychological impairments,
  • •have experienced a severe, disabling stroke within the previous 6 months
  • •are unable to communicate in English.
  • •are currently taking part in other research project, or was part of research in the previous 6 months.
  • •have experienced a heart attack, or unstable angina within the previous 3 months.
  • •already receive advice that includes exercise and diet by health professionals and were referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months

研究组 & 干预措施

Comprehensive Geriatric Assessment (CGA)

Active Comparator

Participants in this arm will undertake a Comprehensive Geriatric Assessment, and will be implemented based on Comprehensive Geriatric Assessment Toolkit for Primary Care Practitioners from the British Geriatrics Society. A personalised action plan will be developed and implemented based on the CGA.

干预措施: Frailty care pathway for older people in a rural primary care setting (Other)

Integrated Care for Older PEople (ICOPE)

Experimental

Participants in this arm will undertake the assessment recommended by the World Health Organisation, and will be implemented by the publicly available app. A personalised action plan will be developed and implemented based on the ICOPE.

干预措施: Frailty care pathway for older people in a rural primary care setting (Other)

Identification and Management of frailty and sarcopenia

Experimental

Participants in this arm will undertake the assessment recommended by the International Conference on Frailty and Sarcopenia Research Clinical Practice Guidelines for Identification and Management of physical frailty (ICFSR). A personalised action plan will be developed and implemented based on the ICFSR.

干预措施: Frailty care pathway for older people in a rural primary care setting (Other)

Functional Fitness Battery (FFB)

Experimental

Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status

干预措施: Frailty care pathway for older people in a rural primary care setting (Other)

Usual Care

No Intervention

Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider.

结局指标

主要结局

Frequency of health care use

时间窗: 12 months

The number of hospital admissions and GP visits in the preceding 12 months

Recruitment rate (feasibility determination)

时间窗: 6 months

The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.

Drop out rate (feasibility determination)

时间窗: 12 months

The drop out rate reflects the number of participants lost to follow up, response rates and adherence/compliance to the intervention.

electronic Frailty Index

时间窗: 12 months

This score reflects the number of accumulated deficits

次要结局

  • Usual Walking Speed(12 months)
  • Physical Activity Level(12 months)
  • Grip Strength(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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