Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Frailty Assesment in the Congestive Heart Failure Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465605
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief 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 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


Condition or disease Intervention/treatment
Fragility Syndrome Congestive Heart Failure Diagnostic Test: frailty test

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Frailty Assesment in the Congestive Heart Failure Clinic
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Diagnostic Test: frailty test
    questionnaire


Primary Outcome Measures :
  1. An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment. [ Time Frame: 1 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • patients an the Meir congestive heart failure clinic.
  • age 70 and above
  • can sign an informed consent

Exclusion Criteria:

  • patients admitted in the last two month

Additional Information:

Layout table for additonal information
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03465605     History of Changes
Other Study ID Numbers: 0072-17MMC
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Frailty
Heart Diseases
Cardiovascular Diseases
Pathologic Processes