Atrial FibrillationNCT03420326
The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling Elderly
An observational study of Atrial Fibrillation and Frail Elderly Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Frail Elderly Syndrome
- What is being tested?
- Frailty status assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 256 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jan 2018to 1 Jun 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: National Taiwan University Hospital Communities in Taipei city
Who may be able to join
- Older than 65 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling
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.
- Conditions
- Atrial Fibrillation, Frail Elderly Syndrome
- Being tested
- Frailty status assessment
- Keywords
- Atrial Fibrillation, Frailty status, Body composition, Sarcopenia
- Medical subject headings
- Atrial Fibrillation, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty status assessmentBehavioural
The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Frailty status assessment | |
| Non-AF group | 1. No detection of AF during 30 seconds ECG assessment
2. Undergo the frailty status assessment Receives: Behavioral: Frailty status assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status
Edmonton frail scale and Frailty criteria by Dr. Fried would be used to evaluate the frail status of the participants
Measured: The frail status assessment would take about 10 minutes
Secondary outcomes (1)
Body composition
Maltron BioScan BF-920, Essex, UK would be used to assess participants' body composition
Measured: The body composition test would take about 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Yueh Chien, Study chair, College of medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420326
- Sponsor's protocol ID
- 201711083RIND
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 5 Mar 2019
- 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 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling
- ClinicalTrials.gov ID
- NCT03420326
- Acronym / sponsor ID
- 201711083RIND
- Conditions
- Atrial Fibrillation, Frail Elderly Syndrome
- Keywords
- Atrial Fibrillation, Frailty status, Body composition, Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Feb 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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atria fibrillation (AF) group | – | Behavioral: Frailty status assessment1. Detection of AF during 30 seconds ECG assessment 2. Once diagnosed with atrial fibrillation before 3. Undergo the frailty status assessment |
| Non-AF group | – | Behavioral: Frailty status assessment1. No detection of AF during 30 seconds ECG assessment 2. Undergo the frailty status assessment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- National Taiwan University Hospital Communities in Taipei city
Key inclusion criteria (1 listed)
- Older than 65 years old
Key exclusion criteria (5 listed)
- 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
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 status assessmentThe Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status | Behavioural | Atria fibrillation (AF) group, Non-AF group |
Primary outcome
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
1 secondary outcome
Body composition
Time frame: The body composition test would take about 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
Meng-Yueh Chien study chair
College of medicine, National Taiwan University
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 Atrial Fibrillation and Frail Elderly Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Mar 2019. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frailty status (time frame: The frail status assessment would take about 10 minutes). 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 5 Mar 2019.