Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction

A study testing AF CARE in people with Atrial Fibrillation, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF). The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: AF CARE
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2019to 26 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

BMI > 28 kg/m2 AND one additional CVRF using LS7
Access and willingness to engage in digital technology
Has a valid email address and a cell phone number
Able to ambulate
Able to speak/read English

Who cannot join

Class III/IV heart failure
MI or cardiac surgery in prior 3 months
Severe renal/hepatic disease
Active malignancy
Current/recent (within 6 months) enrollment in weight loss program

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Health Care
Stanford, California, 94305

Other trials in United States

About this study

Official title: Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial

The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).

The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.

Conditions: Atrial Fibrillation
Being tested: AF CARE, Usual Care
Keywords: Text Messaging, Patient Education, Psychometric
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AF CAREDevice
Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
Usual CareBehavioural
Participants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later

Study groups in NCT04050982
Study group	Role	What they receive
Pilot Testing	Experimental	Patients interface with the digital application, providing feedback on usability and satisfaction. Receives: Device: AF CARE
AF CARE plus Usual Care	Active comparator	Patients will interface with the digital application. Receives: Device: AF CARE; Behavioral: Usual Care
Usual Care then AF Care	Active comparator	After a 6 month period of usual care only, patients will interface with the digital application. Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Text Messages That Were Reviewed
Measured: Baseline through month 6
Percentage of Emails Opened and Clicked Through
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Measured: Baseline through month 6
Cardiovascular Risk Factor Score
The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk
Measured: Baseline, month 3, month 6, and month 12

Secondary outcomes (4)

Change From Baseline in Knowledge Related to Atrial Fibrillation
AF knowledge assessed with the Jessa AF Knowledge Score calculated from a 16 question self- reported questionnaire with a scoring range from 0-16, 16 indicating greater knowledge.
Measured: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Quality of Life Score
Quality of Life assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT score is a combined score of 21 items; overall score range is 21 to 100, with a higher score representing greater QOL.
Measured: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Severity
AF symptom severity assessed with the Atrial Fibrillation Symptoms Severity Scale (AFSS). The AFSS is a patient self-reported questionnaire that contains 21 questions, with 7 questions that provide calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Measured: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Burden
AF symptom burden assessed with the Atrial Fibrillation Symptom Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions that provides calculated scores for AF Burden, calculated in the following manner; AF Burden = AF frequency + AF duration + AF severity. Each of the 3 measures contribute equally to the AF burden score, and each measure ranges from 1-10 to yield Total AF Burden scores ranging from 3-30. Higher scores indicate greater AF burden.
Measured: Baseline, month 3, month 6, and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201926 Jan 2023

First posted9 Aug 2019
Study start1 Oct 2019
Primary completion26 Jan 2023
Study completion26 Jan 2023

Why it stopped: Acquisition of digital messaging company and decision made to withdraw study support

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized control trial
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050982
Sponsor's protocol ID: IRB# 48183
Acronym: AFCARE
Status last verified: Aug 2023
First submitted: 7 Aug 2019
Last updated: 22 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study to Improve Atrial Fibrillation Outcomes Using a Digital Application for Cardiovascular Risk Reduction: Precursor to a Multicenter Randomized Trial
ClinicalTrials.gov ID: NCT04050982
Acronym / sponsor ID: AFCARE / IRB# 48183
Conditions: Atrial Fibrillation
Keywords: Text Messaging, Patient Education, Psychometric
Study type: Interventional
Recruitment status: TerminatedReason stopped: Acquisition of digital messaging company and decision made to withdraw study support
Enrolment: 11 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: American Heart Association, PatientBond
Study start: 1 Oct 2019 (actual)
Primary completion: 26 Jan 2023 (actual)
Study completion: 26 Jan 2023 (actual)
First posted: 9 Aug 2019 (actual)
Results: Posted 22 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Randomized control trial

Arm	Type	Receives
Pilot Testing	Experimental	Device: AF CAREPatients interface with the digital application, providing feedback on usability and satisfaction.
AF CARE plus Usual Care	Active comparator	Device: AF CARE, Behavioral: Usual CarePatients will interface with the digital application.
Usual Care then AF Care	Active comparator	Behavioral: Usual CareAfter a 6 month period of usual care only, patients will interface with the digital application.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

BMI > 28 kg/m2 AND one additional CVRF using LS7
Access and willingness to engage in digital technology
Has a valid email address and a cell phone number
Able to ambulate
Able to speak/read English

Key exclusion criteria (5 listed)

Class III/IV heart failure
MI or cardiac surgery in prior 3 months
Severe renal/hepatic disease
Active malignancy
Current/recent (within 6 months) enrollment in weight loss program

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
AF CAREPatients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.	Device	AF CARE plus Usual Care, Pilot Testing
Usual CareParticipants will be given recommendations for CVRF reduction based on their initial American Heart Association Life Simple 7 (LS7) assessment and will be provided educational materials and be wait listed for digital app 3 months later	Behavioural	AF CARE plus Usual Care, Usual Care then AF Care

Primary outcome

Percentage of Text Messages That Were Reviewed
Time frame: Baseline through month 6
Percentage of Emails Opened and Clicked Through
Time frame: Baseline through month 6
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Cardiovascular Risk Factor Score
Time frame: Baseline, month 3, month 6, and month 12
The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk

4 secondary outcomes

Change From Baseline in Knowledge Related to Atrial Fibrillation
Time frame: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Quality of Life Score
Time frame: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Severity
Time frame: Baseline, month 3, month 6, and month 12
Change From Baseline in AF Symptom Burden
Time frame: Baseline, month 3, month 6, and month 12

Results and safety

Results posted to the registry on 22 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot Testing	9	7
AF CARE Plus Usual Care	2	1
Usual Care Then AF Care	0	0

Primary outcome: Percentage of Text Messages That Were Reviewed

Time frame: Baseline through month 6. Mean (Full Range). Unit: percentage of texts

Measure	Pilot Testing n = 7
Value	29.2 (0 to 60.0)

Population analysed: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.

Primary outcome: Percentage of Emails Opened and Clicked Through

Time frame: Baseline through month 6. Mean (Full Range). Unit: percentage of emails

Measure	Pilot Testing n = 7
Emails opened	72.2 (19 to 97)
Emails clicked through	74.3 (36 to 100)

Population analysed: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.

Primary outcome: Cardiovascular Risk Factor Score

Time frame: Baseline, month 3, month 6, and month 12. Mean (Standard Deviation). Unit: score on a scale

Measure	AF CARE Plus Usual Care n = 1
baseline	6.5 (0)
month 3	8 (0)
month 6	6.5 (0)
month 12	7 (0)

Population analysed: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Testing	0 of 9 (0%)	0 of 9 (0%)	0 of 9
AF CARE Plus Usual Care	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The study did not meet its planned enrollment size, and did not achieve statistical power.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruiting
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
Atrial Fibrillation (AF), Heart Failure

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.

Linda Ottoboni, PhD principal investigator

Clinician and research scientist

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AF CARE in people with Atrial Fibrillation, run by Stanford University at 1 site in United States.

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 5 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: stopped early, as of the sponsor's last update on 22 Sep 2023. 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 United States. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Text Messages That Were Reviewed (time frame: Baseline through month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050982.

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 22 Sep 2023.