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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
Sponsor:
Collaborator:
Burdett Trust for Nursing
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
Rocha (2017), published a systematic review and meta-analysis highlighting the clinical utility of frailty scales for the prediction of post-operative complications. The results of the review of 15 studies show that, overall, frailty significantly increases the risk for developing adverse outcomes such as, mortality, morbidity and extended length of hospital stay. However, different frailty scales showed different prevalence of frailty even when tested in the same population, which means that future studies are required for a better understanding of frailty tools. Early detection of frailty may provide a window of opportunity for intervention and a key factor to determine clinical outcomes.

Condition or disease Intervention/treatment
Frailty Other: Frailty Assessment

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.

    As above



Secondary Outcome Measures :
  1. Frailty assessment via the FRIED criteria [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]
    Assessment using the FRIED frailty tool

  2. Frailty assessment via the EDMONTON frailty criteria [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]
    Assessment using the EDMONTON frailty criteria

  3. Frailty assessment via the PRISMA frailty score [ Time Frame: Baseline, 6 weeks and 6 months post procedure ]
    Assessment using the PRISMA frailty tool



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 70 years and above scheduled to receive an elective cardiac intervention.
Criteria

Inclusion Criteria:

  1. Age of 70 and above
  2. Scheduled to receive an elective cardiac procedure.
  3. Willing to undergo frailty assessment
  4. Able to walk with or without aids.
  5. Willingness to attend a 6 week and 6 months follow up appointments.
  6. Able to provide full informed consent. -

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Scheduled to receive an emergency procedure -

Information from the National Library of Medicine

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


Locations
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United Kingdom
Harefield Hospital
Harefield, Middlesex, United Kingdom, UB9 6JH
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Burdett Trust for Nursing
Investigators
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Principal Investigator: Paula Rogers, RGN, BSc, MSc Royal Brompton and Harefield NHS Foundation Trust
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04061317    
Other Study ID Numbers: V1 - 08-04-2019
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes