SPOT FRAILTY: SPOT-FRAILTY Assessment of Frailty in Patients Over the Age of 70 Undergoing a Cardiac Intervention

Sponsor
Royal Brompton & Harefield NHS Foundation Trust (Other)
Overall Status
Terminated
CT.gov ID
NCT04061317
Collaborator
Burdett Trust for Nursing (Other)
82
1
14.4
5.7

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Aug 19, 2019
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Oct 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Incidence of frailty in a population undergoing cardiac intervention [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 [Baseline, 6 weeks and 6 months post procedure]

    Assessment using the FRIED frailty tool

  2. Frailty assessment via the EDMONTON frailty criteria [Baseline, 6 weeks and 6 months post procedure]

    Assessment using the EDMONTON frailty criteria

  3. Frailty assessment via the PRISMA frailty score [Baseline, 6 weeks and 6 months post procedure]

    Assessment using the PRISMA frailty tool

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harefield Hospital Harefield Middlesex United Kingdom UB9 6JH

Sponsors and Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust
  • Burdett Trust for Nursing

Investigators

  • Principal Investigator: Paula Rogers, RGN, BSc, MSc, Royal Brompton and Harefield NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT04061317
Other Study ID Numbers:
  • V1 - 08-04-2019
First Posted:
Aug 19, 2019
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2020