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临床试验/NCT03902743
NCT03902743Unknown不适用

Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study

Queen's University, Belfast2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年3月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
64
试验地点
2
主要终点
EQ-5D-5L

研究概览

简要总结

The purpose of this study is to explore the feasibility of delivering anticipatory care planning provided by nurses through a series of home visits. Many people with long-term health conditions can benefit from an anticipatory care plan as it helps them feel more in control of their life and allows them to manage changes in their health and well-being. The purpose of this study is to find out if effect of home visits by specially trained nurses for people aged 70 years and over who have been identified as being 'at risk' of developing frailty would be beneficial. Half of the patients in this study will receive home visits from trained nurses in addition to their usual care. Nurses will work with their GP, other healthcare providers and possibly family caregivers to plan and arrange any additional services that the participants require. The other half of patients in the study will receive usual care.

详细描述

Aim: to determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.

Design and sample:

We will perform a feasibility cluster randomised controlled trial where 8 primary care practises will be randomly assigned (4 facilities per arm) to the intervention group versus usual care alone. Randomisation will be stratified according to location (Northern Ireland /Republic of Ireland - Louth, Monaghan). Primary care practices will be randomly allocated to the intervention or usual care arm before patient screening for risk of functional decline. A total of 64 patients (32 per study arm, 8 patients, randomly selected, per primary care practise) will be enrolled into the study. A sample of 32 patients per study arm is considered adequate to allow the size of any definitive trial to be determined more accurately and therefore minimise the number of patients required overall.

Setting:

Practices located in Northern Ireland will be recruited via the Northern Ireland Clinical Research Network (Primary Care). In the Republic of Ireland the HRB Primary Care Trials Network will recruit primary care practises located in the border counties of Louth and Monaghan. Practises will be drawn from both urban and rural settings that serve a socioeconomically deprived population.

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
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥70 years
  • In receipt of a valid general medical services (GMS) card in the Republic of Ireland, or for Northern Ireland registered for NHS primary care services
  • ability to complete a postal questionnaire

排除标准

  • receiving specialist palliative care
  • record of assessed cognitive impairment at the level that would impact their ability to complete screening postal questionnaire, outcome measures and participate in a patient care conference(s) (defined as Mini Mental State Examination (MMSE) ≤20)
  • experiencing a psychotic episode at the time of recruitment
  • hospitalised long-term, in a nursing home, homeless or in sheltered accommodation

结局指标

主要结局

EQ-5D-5L

时间窗: 10 minutes

Is a widely used self-reported generic measure of health reported quality of life that has been validated in different patient populations. The five-level version contains the same dimensions as the earlier three-level version but has been designed to provide greater reliability and sensitivity.

Center for Epidemiological Studies Depression Scale (CES-D)

时间窗: 10 minutes

This 20- item scale has been used extensively with older adults. Respondents use a four choice scale to rate how they have felt in the past week expressing depressed mood.

次要结局

  • Patient Assessment of Chronic Illness Care (PACIC) Scale(15 minutes)
  • Health Economic Evaluation(15 minutes)

研究者

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

Kevin Brazil

Professor Kevin Brazil

Queen's University, Belfast

研究点 (2)

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