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

NCT04061317 | Terminated

• 1 other identifier: V1 - 08-04-2019
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frailty assessment via the FRIED criteria

  Baseline, 6 weeks and 6 months post procedure

• Frailty assessment via the EDMONTON frailty criteria

  Baseline, 6 weeks and 6 months post procedure

• Frailty assessment via the PRISMA frailty score

  Baseline, 6 weeks and 6 months post procedure

Interventions

Frailty Assessment OTHER

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.

Also known as: Quality of Life Assessment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent
• Scheduled to receive an emergency procedure -

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Burdett Trust for Nursing: collaborator

Study Sites (1)

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paula Rogers, RGN, BSc, MSc

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: August 19, 2019
• Study Start: August 19, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

GB (1)