FrailtySPOT FRAILTYNCT04061317
SPOT-FRAILTY Assessment of Frailty in Patients Over the Age of 70 Undergoing a Cardiac Intervention
An observational study of Frailty, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Frailty Assessment
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: Patients aged 70 years and above scheduled to receive an elective cardiac intervention.
Who may be able to join
- 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. -
Who cannot join
- Unable to provide informed consent
- Scheduled to receive an emergency procedure -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Frailty Assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty AssessmentOther
Also called Quality of Life 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 weeks and 6 months post procedure
Secondary outcomes (3)
Frailty assessment via the FRIED criteria
Assessment using the FRIED frailty tool
Measured: Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the EDMONTON frailty criteria
Assessment using the EDMONTON frailty criteria
Measured: Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the PRISMA frailty score
Assessment using the PRISMA frailty tool
Measured: Baseline, 6 weeks and 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start19 Aug 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: COVID Restrictions in a vulnerable population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Burdett Trust for Nursing
- Responsible party
- Sponsor
- Investigators
- Paula Rogers, RGN, BSc, MSc, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061317
- Sponsor's protocol ID
- V1 - 08-04-2019
- Acronym
- SPOT FRAILTY
- Status last verified
- Nov 2020
- First submitted
- 15 Apr 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to exPlOre the exisTence and Impact of FRAILTY in Patients Over the Age of 70 Undergoing Cardiac Interventions
- ClinicalTrials.gov ID
- NCT04061317
- Acronym / sponsor ID
- SPOT FRAILTY / V1 - 08-04-2019
- Conditions
- Frailty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID Restrictions in a vulnerable population.
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Burdett Trust for Nursing
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients aged 70 years and above scheduled to receive an elective cardiac intervention.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Scheduled to receive an emergency procedure -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty AssessmentAlso: Quality of Life AssessmentWe 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 | – |
Primary outcome
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
3 secondary outcomes
Frailty assessment via the FRIED criteria
Time frame: Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the EDMONTON frailty criteria
Time frame: Baseline, 6 weeks and 6 months post procedure
Frailty assessment via the PRISMA frailty score
Time frame: Baseline, 6 weeks and 6 months post procedure
Results and safety
The study was stopped early (reason given: COVID Restrictions in a vulnerable population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Rogers, RGN, BSc, MSc principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID Restrictions in a vulnerable population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of frailty in a population undergoing cardiac intervention (time frame: Baseline, 6 weeks and 6 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.