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

A Pilot Study to exPlOre the exisTence and Impact of FRAILTY in Patients Over the Age of 70 Undergoing Cardiac Interventions

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.

Study Overview

• Status: Terminated
• Conditions: Frailty
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harefield, Middlesex, United Kingdom, UB9 6JH
      • Harefield Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 70 years and above scheduled to receive an elective cardiac intervention.

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of frailty in a population undergoing cardiac intervention	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	Baseline, 6 weeks and 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty assessment via the FRIED criteria	Assessment using the FRIED frailty tool	Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the EDMONTON frailty criteria	Assessment using the EDMONTON frailty criteria	Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the PRISMA frailty score	Assessment using the PRISMA frailty tool	Baseline, 6 weeks and 6 months post procedure

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Burdett Trust for Nursing
• Investigators: Principal Investigator: Paula Rogers, RGN, BSc, MSc, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: V1 - 08-04-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No