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临床试验/NCT06099691
NCT06099691已完成不适用

Investigating Outcomes That Matter and the Suitability of PROMs for Older People Living With Frailty

Royal Devon and Exeter NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Identify outcomes that matter to older people with frailty

研究概览

简要总结

The goal of this qualitative study is to investigate what matters to older people living with frailty, and how this can be measured using questionnaires (Patient Reported Outcome Measures, or "PROMs").

The research questions are:

  1. What outcomes matter to older adults living with frailty?
  2. What are participants' perceptions of PROMs that could measure these outcomes?

Our estimated sample will be 15 older adults, approximately 5 people living with mild frailty, 5 living with moderate frailty and 5 living with severe frailty. Participants will take part in one 90-minute interview.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Over the age of 65
  • Indication of frailty in one of the following ways:
  • Clinical diagnosis of frailty
  • Assessment of at least "4" on the Clinical Frailty Scale by a healthcare professional
  • Having mental capacity to consent to participate as defined under the Mental Capacity Act (2005). This will be assessed in the telephone conversation prior to the interview by a researcher who has received Mental Capacity training
  • Available to be interviewed by face-to-face interview at the National Institute of Health Research (NIHR) Exeter Clinical Research Facility or as a home visit, or as an online meeting

排除标准

  • Not able to participate in face-to-face interview or use video call technology
  • Not assessed as frail
  • Not able to express thoughts and opinions in sufficient depth for analysis, even with facilitation by a relative or carer. This will be assessed in the telephone conversation with the researcher prior to the interview.
  • Lacking capacity to consent to participate as defined under the Mental Capacity Act (2005). An individual would be unable to participate if they cannot:
  • Understand the information relevant to the decision of participating
  • Retain that information
  • Use or weigh up that information as part of the process of deciding whether to participate
  • Communicate their decision to other people

结局指标

主要结局

Identify outcomes that matter to older people with frailty

时间窗: 6 months

Qualitative interviews will be conducted with older people living with frailty to identify what matters to people (e.g. managing pain, functional independence, suitability of medications, social support). This may vary at different severities of frailty.

Investigate perceptions of questionnaires

时间窗: 6 months

Qualitative interviews will be conducted with older people living with frailty to investigate participants' perceptions of PROMs (questionnaires) that could measure outcomes that matter to them.

次要结局

未报告次要终点

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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