Fragility SyndromeNCT03465605
Frailty Assesment in the Congestive Heart Failure Clinic
An observational study of Fragility Syndrome and Congestive Heart Failure, run by Meir Medical Center.
Trial summary
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Fragility Syndrome, Congestive Heart Failure
- What is being tested?
- frailty test
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2019
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Older adult
Study population: Patients 70 years old and older visiting the congestive heart failure clinic at the Meir Medical Center, who can sign an informed consent and hasn't been admitted to the hospital in the past two month.
Who may be able to join
- patients an the Meir congestive heart failure clinic.
- age 70 and above
- can sign an informed consent
Who cannot join
- patients admitted in the last two month
About this study
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and the need to ensure a stronger social support system for the patient. Frailty assessment is usually made subjectively by the cardiologist, known in the literature as eyeball testing.
In this study the investigators will compare the cardiologists subjective eyeball testing to objective frailty assessment tests based on Fried score and Edmonton frail scale
Read the detailed description
Elderly patients visiting the congestive heart failure clinic at Meir Medical Center will be assessed for frailty twice. Once in an "eyeball" test by their cardiologist at the clinic, and a second time in an objective test based on fried and Edmonton frailty scores.
The second subjective assessment will be made by geriatric and internal medicine physicians, and the cardiologist won't be aware of the results of the objective assessment.
The results of both tests will be compared.
- Conditions
- Fragility Syndrome, Congestive Heart Failure
- Being tested
- frailty test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frailty testDiagnostic test
questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragility SyndromeStudies 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465605
- Sponsor's protocol ID
- 0072-17MMC
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assesment in the Congestive Heart Failure Clinic
- ClinicalTrials.gov ID
- NCT03465605
- Acronym / sponsor ID
- 0072-17MMC
- Conditions
- Fragility Syndrome, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 14 Mar 2018 (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.
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and the need to ensure a stronger social support system for the patient. Frailty assessment is usually made subjectively by the cardiologist, known in the literature as eyeball testing.
In this study the investigators will compare the cardiologists subjective eyeball testing to objective frailty assessment tests based on Fried score and Edmonton frail scale
Detailed description
Elderly patients visiting the congestive heart failure clinic at Meir Medical Center will be assessed for frailty twice. Once in an "eyeball" test by their cardiologist at the clinic, and a second time in an objective test based on fried and Edmonton frailty scores.
The second subjective assessment will be made by geriatric and internal medicine physicians, and the cardiologist won't be aware of the results of the objective assessment.
The results of both tests will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients 70 years old and older visiting the congestive heart failure clinic at the Meir Medical Center, who can sign an informed consent and hasn't been admitted to the hospital in the past two month.
Key inclusion criteria (3 listed)
- patients an the Meir congestive heart failure clinic.
- age 70 and above
- can sign an informed consent
Key exclusion criteria (1 listed)
- patients admitted in the last two month
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 testquestionnaire | Diagnostic test | – |
Primary outcome
An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragility Syndrome and Congestive Heart Failure, run by Meir Medical Center.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment. (time frame: 1 week). 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 19 Mar 2018.