NCT03420326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 5, 2019

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

January 25, 2018

Last Update Submit

March 3, 2019

Conditions

Keywords

Atrial FibrillationFrailty statusBody compositionSarcopenia

Outcome Measures

Primary Outcomes (1)

  • Frailty status

    Edmonton frail scale and Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants

    The frail status assessment would take about 10 minutes

Secondary Outcomes (1)

  • Body composition

    The body composition test would take about 10 minutes

Study Arms (2)

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

Non-AF group

1. No detection of AF during 30 seconds ECG assessment 2. Undergo the frailty status assessment

Behavioral: Frailty status assessment

Interventions

The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status

Atria fibrillation (AF) groupNon-AF group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

National Taiwan University Hospital Communities in Taipei city

You may qualify if:

  • Older than 65 years old

You may not qualify if:

  • diagnosed with the following disease
  • Cardiovascular diseases: myocardial infarction, peripheral vascular diseases, aortic plaque
  • Cerebrovascular disease: stroke, transient ischemic attack, emboli
  • Heart failure
  • Participants who cannot finish the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ming-Ting Yang

Taipei, Zhongzheng District, 100, Taiwan

Location

MeSH Terms

Conditions

Atrial FibrillationSarcopenia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Meng-Yueh Chien

    College of medicine, National Taiwan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 5, 2018

Study Start

January 26, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 5, 2019

Record last verified: 2018-01

Locations