ClinicalTrials.gov
ClinicalTrials.gov Menu

The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling Elderly

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: NCT03420326
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Atrial fibrillation (AF) is the most common arrhythmias in clinical practice. Research investigating hospitalized patients have indicated there are deleterious effects of AF on patients besides the disease burden itself, including longer stay days for hospitalization, higher rates of frailty and increasing mortality rate after discharged in six months. In the community-dwelling research also found that elderly with AF have lower cognitive function, physical functional tests score and slower walking speed compared with the health ones. However, there is limited articles investigating the impact of AF on community-dwelling elderly, and the relationship between AF and frailty is also lack of discussion. According to the aged society and increasing prevalence of AF, the relationship between AF and frailty in community-dwelling elderly is warranting investigated.

Condition or disease Intervention/treatment
Atrial Fibrillation Frail Elderly Syndrome Behavioral: Frailty status assessment

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atria fibrillation (AF) group
  1. Detection of AF during 30 seconds ECG assessment
  2. Once diagnosed with atrial fibrillation before
  3. Undergo the frailty status assessment
Behavioral: Frailty status assessment
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status

Non-AF group
  1. No detection of AF during 30 seconds ECG assessment
  2. Undergo the frailty status assessment
Behavioral: Frailty status assessment
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status




Primary Outcome Measures :
  1. Frailty status [ Time Frame: The frail status assessment would take about 10 minutes ]
    Edmonton frail scale and Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants


Secondary Outcome Measures :
  1. Body composition [ Time Frame: The body composition test would take about 10 minutes ]
    Maltron BioScan BF-920, Essex, UK would be used to assess participants' body composition



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.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
National Taiwan University Hospital Communities in Taipei city
Criteria

Inclusion Criteria:

  • Older than 65 years old
  • Had the symptom of palpitation over the past year

Exclusion Criteria:

once diagnosed with the following disease

  1. Cardiovascular diseases: myocardial infarction, peripheral vascular diseases, aortic plaque
  2. Cerebrovascular disease: stroke, transient ischemic attack, emboli
  3. Heart failure
  4. Participants who cannot finish the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03420326


Contacts
Contact: Meng-Yueh Chien +886-2-33228141 mychien@ntu.edu.tw
Contact: Ming-Ting Yang +886-912172033 r05428004@ntu.edu.tw

Locations
Taiwan
Ming-Ting Yang Recruiting
Taipei, Zhongzheng District, Taiwan, 100
Contact: Meng-Yueh Chien    +886-2-33668141    mychien@ntu.edu.tw   
Contact: Ming-Ting Yang    +886-2-33228141    r05428004@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Meng-Yueh Chien College of medicine, National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03420326     History of Changes
Other Study ID Numbers: 201711083RIND
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Atrial Fibrillation
Frailty status
Body composition
Sarcopenia

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes