SPOT-FRAILTY Assessment of Frailty in Patients Over the Age of 70 Undergoing a Cardiac Intervention (SPOT FRAILTY)
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|ClinicalTrials.gov Identifier: NCT04061317|
Recruitment Status : Terminated (COVID Restrictions in a vulnerable population.)
First Posted : August 19, 2019
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment|
|Frailty||Other: Frailty Assessment|
The investigators anticipate that this project will allow the creation of a registry to describe our population in terms of the presence or absence of frailty. The investigators will use validated measures to determine existence of frailty prior to interventional cardiac procedures (PRISMA-7, Edmonton and FRIED Frailty Index). The measures will be repeated at 6 weeks and 6 months post procedure. Clinical data will also be collected to assess any links between frailty and clinical outcomes. Data collection sheets will be designed, data will be entered and analyzed by a statistician.. If the data provides meaningful insight, the investigator will aim to create a specific frailty tool for the cardiac population.
The investigators are also keen to understand the effects of health-related quality of life on frailty and will be collecting generic data via the SF-36 and EQ5-D. In order to assess the lived experience of frailty, the investigators are proposing a qualitative interview for 15 willing patients, to allow the exploration of the concepts of frailty in more detail for patients who have undergone a cardiac intervention.
The totality of the data collection will help the study team examine care pathways and assess any areas of concern, which may be addressed for the benefit of patients in the future.
Once we have gathered data to define the population in terms of frailty and the impact of frailty on health-related quality of life, the investigators aim to adapt the services to accommodate the needs of frail patients undergoing heart procedures. This may involve amended pre-admission care which may influence discharge planning, depending on the nature of the individual patients. An integrated care pathway (ICP) is a step by step approach to patient care which also considers the requirements of research, training, resources, clinical governance and performance. It is anticipated that an amended ICP may be created for patients with frailty. . This initial project will form part of a longer-term plan to assess and manage frailty in a systematic process.
|Study Type :||Observational|
|Actual Enrollment :||82 participants|
|Official Title:||A Pilot Study to exPlOre the exisTence and Impact of FRAILTY in Patients Over the Age of 70 Undergoing Cardiac Interventions|
|Actual Study Start Date :||August 19, 2019|
|Actual Primary Completion Date :||October 31, 2020|
|Actual Study Completion Date :||October 31, 2020|
- Other: Frailty Assessment
We will use validated measures to determine existence of frailty prior to interventional cardiac procedures (PRISMA-7, Edmonton and FRIED Frailty Index). We will repeat the measures at 6 weeks and 6 months post procedure. We will also collect clinical data to assess any links between frailty and clinical outcomes.
We are also keen to understand the effects of health-related quality of life on frailty and will be collecting generic data via the SF-36 and EQ5-D.Other Name: Quality of Life Assessment
- Incidence of frailty in a population undergoing cardiac intervention [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]
The primary endpoint is to describe our population related to validated frailty assessment tools and explore any associations with a generic quality of life measure.
- Frailty assessment via the FRIED criteria [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]Assessment using the FRIED frailty tool
- Frailty assessment via the EDMONTON frailty criteria [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]Assessment using the EDMONTON frailty criteria
- Frailty assessment via the PRISMA frailty score [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]Assessment using the PRISMA frailty tool
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061317
|Harefield, Middlesex, United Kingdom, UB9 6JH|
|Principal Investigator:||Paula Rogers, RGN, BSc, MSc||Royal Brompton and Harefield NHS Foundation Trust|