Atrial FibrillationNCT03259893
Secondary Prevention of Atrial Fibrilation
A study testing AliveCor mobile ECG cardiac monitor and AF Program in people with Atrial Fibrillation and Risk Factors, run by Boston Medical Center at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for adults over age 40 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Risk Factors, Risk Reduction Behavior
- What is being tested?
- AliveCor mobile ECG cardiac monitor and AF Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 11 May 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor showing AF).
- Body mass index of greater than 27 kg/m2
- Eligibility to participate in cardiac rehabilitation with negative exercise stress test within 6 months.
Who cannot join
- Permanent AF.
- Undergone catheter ablation of AF in past 6 months.
- Class I or Class III anti-arrhythmic drugs at the time of enrollment
- Unable to participate in cardiac rehabilitation.
- Prognosis of less than 1-year.
- Do not own a smart phone.
Show all 12Show fewer
- Unable to operate (transmit data) their smart phone.
- Are not fluent in English or Spanish.
- Unable to read in English or Spanish.
- Not able to provide informed consent.
- Women who are pregnant.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boston Medical Center Secondary Prevention of Atrial Fibrillation Randomized Pilot Study
Atrial fibrillation (AF) is the most common arrhythmia affecting over 3 million Americans and about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for adults over age 40 years. AF is associated with a major medical and socioeconomic burden including high cost, increased risk of stroke, heart failure, dementia, myocardial infarction, and death. Numerous studies have demonstrated that modifiable risk factors including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the development of AF.
Recent studies have reported that secondary prevention interventions through aggressive risk factor modification can reduce the burden of AF. Structured, physician and nursing-led interdisciplinary AF programs have been shown to improve patient adherence to guideline recommendations and improve long term prognosis. Previous data, however, are derived mainly from white European and Australian cohorts and it is unclear whether such interventions can be effectively implemented in a racially diverse, safety net hospital in the U.S.
This study is a randomized hybrid implementation-effectiveness study designed to investigate feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk factor modification and AF education in a racially mixed population receiving care in a safety net hospital.
Read the detailed description
The proposed study is designed as a Hybrid Type 3 effectiveness-implementation study. This study design will enable the investigators to primarily focus on core implementation outcomes while also assessing the effectiveness of the intervention on clinical outcomes. Since this is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation components, but the primary focus is on the implementation outcomes of feasibility, acceptability, adoption, and appropriateness. The specific aims, data collection, and analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that posits improvements in outcomes are dependent not only on the evidence-based interventions that are implemented but on the implementation strategies used to implement those interventions. The model distinguishes between the intervention strategy (evidence-based practice), different types of implementation strategies (system environment, organizational, group/learning, supervision, individual providers/consumers), and three levels of outcomes (implementation, service, and client). The appropriate outcome measures in each category (implementation, service, client) depend upon the specific evidence-based practice and local context.
AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic, inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC) will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1 randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program (intervention- group 2). Randomization will be performed using a computer randomizer algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50 participants. The rational for the randomization design is primarily for the purpose of feasibility and to establish effect sizes and guide the design of the future trial.
All patients will be enrolled for a total duration of six months. Outcomes will be measured via 30-minute individual interviews at the end of 6-months. The implementation and service outcomes will be examined including acceptability, appropriateness, adoption, feasibility, and patient centeredness, as well as the client outcomes of satisfaction, function and symptomatology. Data will be collected using both quantitative and qualitative data methods to determine which aspects of the program achieved good patient adherence and acceptability.
- Conditions
- Atrial Fibrillation, Risk Factors, Risk Reduction Behavior
- Being tested
- AliveCor mobile ECG cardiac monitor, AF Program, Standard of care
- Keywords
- Proctor Conceptual Model of Implementation Research, Prevention, Safety net hospital, Diverse inner city patients
- Medical subject headings
- Atrial Fibrillation, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliveCor mobile ECG cardiac monitorOther
AliveCor mobile ECG cardiac monitor is capable of providing real-time heart telemetry using a smart phone. Participants will be instructed to transmit rhythm data twice weekly and during symptomatic AF.
AF ProgramBehavioural
The AF program includes a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Participants randomized to the intervention group 2 will undergo counseling by the nurse and guided through the structured, goal-directed AF program. Each participant will receive an AliveCor cardiac monitor which is capable of providing real-time heart telemetry using a smart phone.
Standard of careOther
Guideline-directed medical therapy according to clinical standard practice at Boston Medical Center.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group 1 | Active comparator | Participants randomized to the standard of care group will receive guideline-directed medical therapy according to clinical standard practice at Boston Medical Center. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone. Receives: Other: AliveCor mobile ECG cardiac monitor; Other: Standard of care |
| Intervention group 2 | Experimental | The intervention group will receive the AF program which include a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone. Receives: Other: AliveCor mobile ECG cardiac monitor; Behavioral: AF Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the AF program
Quantitative measure of willingness to enroll and attend nutrition clinic, cardiac rehabilitation clinic, and frequency of use of Alivecor device, smart Scale, Fitbit device will be aggregated to generate a single feasibility score to determine overall feasibility of the AF program.
The feasibility score will be generated by the following formula:
= 100 * average of { (actual nutrition clinic attendance/ expected nutrition clinic attendance) + (actual cardiac rehab clinic attendance/ expected cardiac rehab clinic attendance) + (actual use of smart phone enabled devices/expected use of smart phone enabled devices)}
A feasibility score closer to 100% indicates good feasibility.
Measured: 6 months
Secondary outcomes (8)
Acceptability of the AF program
Data from qualitative interviews will be coded using a process analytic framework and inductive logic to create a set of conceptual categories using the Constant Comparative Method and used to assess patient-centeredness and satisfaction which will reflect acceptability of the AF program.
Measured: 6 months
Most acceptable individual component of the AF program
Data from qualitative interviews will be coded using a process analytic framework and inductive logic to create a set of conceptual categories using the Constant Comparative Method and used to compare the acceptability of individual component of AF programs including nutrition clinic, cardiac rehabilitation clinic, smoking cessation clinic, smart phone enable health devices.
Measured: 6 months
Most adopted individual component of the AF program
Quantitative measure of (actual clinic attendance or use of smart phone enable devices) / (expected clinic attendance or use of smart phone enable devices) will be compared for the various components of the AF program including nutrition clinic, cardiac rehabilitation clinic, smoking cessation clinic, Alivecor device, Fitbit device, smart blood pressure monitor, and smart scale. The individual component with the highest % attendance or use will be considered to be the most adopted individual component of the AF program.
Measured: 6 months
Burden of atrial fibrillation
Quantitative measure of telemetry data from Alivecor devices, participants will be instructed to transmit telemetry data twice weekly and during symptomatic AF episodes. Telemetry data showing AF will be used to determine number of AF episodes in each participant over time.
Measured: Twice weekly for 6 months
Atrial fibrillation symptoms
quantitative measure of telemetry data from Alivecor devices and qualitative measures using The Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire is a 20 question, 7 point Likert scale (1-7) instrument that takes about 5 minutes to complete and evaluates Health Related Quality of Life across 3 domains- symptoms (4 questions), daily activities (8 questions), and treatment concerns (6 questions). The range of scores are 20-140, lower scores are favorable.
Measured: 6 months
Atrial fibrillation literacy
AF Knowledge Questionnaire is a 34 question instrument that takes about 10 minutes to complete. It is a modified version of the Jessa Atrial fibrillation Knowledge Questionnaire (JAKQ) and contains questions about AF in general and about oral anticoagulation therapy.
Measured: 6 months
Atrial Fibrillation Effect on Quality of Life
The Atrial Fibrillation Effect on QualiTy of Life (AFEQT) questionnaire is a 20 question, 7 point Likert scale (1-7) instrument that takes about 5 minutes to complete and evaluates Health Related Quality of Life across 3 domains- symptoms (4 questions), daily activities (8 questions), and treatment concerns (6 questions). The range of scores are 20-140, lower scores are favorable.
Measured: 6 months
Hospitalization for atrial fibrillation
quantitative measure of number of hospitalization for atrial fibrillation or outcome attributed to atrial fibrillation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Feb 2018
- Primary completion11 May 2020
- Study completion11 May 2020
Why it stopped: Initially suspended due to COVID-19 policies, it will not be possible to restart.
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 Boston Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Sponsor
- Investigators
- Robert Helm, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259893
- Sponsor's protocol ID
- H-36040
- Other IDs
- H-36040
- Status last verified
- May 2020
- First submitted
- 4 Jul 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Medical Center Secondary Prevention of Atrial Fibrillation Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03259893
- Acronym / sponsor ID
- H-36040
- Conditions
- Atrial Fibrillation, Risk Factors, Risk Reduction Behavior
- Keywords
- Proctor Conceptual Model of Implementation Research, Prevention, Safety net hospital, Diverse inner city patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initially suspended due to COVID-19 policies, it will not be possible to restart.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 24 Aug 2017 (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 arrhythmia affecting over 3 million Americans and about 33.5 million individuals globally. The lifetime risk of developing AF is 1 in 4 for adults over age 40 years. AF is associated with a major medical and socioeconomic burden including high cost, increased risk of stroke, heart failure, dementia, myocardial infarction, and death. Numerous studies have demonstrated that modifiable risk factors including hypertension, obesity, sleep apnea, diabetes, and sedentary lifestyle predict the development of AF.
Recent studies have reported that secondary prevention interventions through aggressive risk factor modification can reduce the burden of AF. Structured, physician and nursing-led interdisciplinary AF programs have been shown to improve patient adherence to guideline recommendations and improve long term prognosis. Previous data, however, are derived mainly from white European and Australian cohorts and it is unclear whether such interventions can be effectively implemented in a racially diverse, safety net hospital in the U.S.
This study is a randomized hybrid implementation-effectiveness study designed to investigate feasibility and effectiveness of an evidence-based innovative AF program, focusing on risk factor modification and AF education in a racially mixed population receiving care in a safety net hospital.
Detailed description
The proposed study is designed as a Hybrid Type 3 effectiveness-implementation study. This study design will enable the investigators to primarily focus on core implementation outcomes while also assessing the effectiveness of the intervention on clinical outcomes. Since this is a Type 3 Hybrid trial, there are both effectiveness and implementation evaluation components, but the primary focus is on the implementation outcomes of feasibility, acceptability, adoption, and appropriateness. The specific aims, data collection, and analytic plans are grounded in the Proctor Conceptual Model of Implementation Research that posits improvements in outcomes are dependent not only on the evidence-based interventions that are implemented but on the implementation strategies used to implement those interventions. The model distinguishes between the intervention strategy (evidence-based practice), different types of implementation strategies (system environment, organizational, group/learning, supervision, individual providers/consumers), and three levels of outcomes (implementation, service, and client). The appropriate outcome measures in each category (implementation, service, client) depend upon the specific evidence-based practice and local context.
AF patients with a BMI of ≥ 27 kg/m2, who are referred to outpatient cardiology clinic, inpatient cardiology service, or cardiology consult service at Boston Medical Center (BMC) will be screened until 50 participants are enrolled. Eligible participants will undergo 1:1 randomization to standard of care (SoC -group 1) or to the interdisciplinary AF program (intervention- group 2). Randomization will be performed using a computer randomizer algorithm with 5 blocks of 6 and 5 blocks of 4 in random order for a total of 50 participants. The rational for the randomization design is primarily for the purpose of feasibility and to establish effect sizes and guide the design of the future trial.
All patients will be enrolled for a total duration of six months. Outcomes will be measured via 30-minute individual interviews at the end of 6-months. The implementation and service outcomes will be examined including acceptability, appropriateness, adoption, feasibility, and patient centeredness, as well as the client outcomes of satisfaction, function and symptomatology. Data will be collected using both quantitative and qualitative data methods to determine which aspects of the program achieved good patient adherence and acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group 1 | Active comparator | Other: AliveCor mobile ECG cardiac monitor, Other: Standard of careParticipants randomized to the standard of care group will receive guideline-directed medical therapy according to clinical standard practice at Boston Medical Center. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone. |
| Intervention group 2 | Experimental | Other: AliveCor mobile ECG cardiac monitor, Behavioral: AF ProgramThe intervention group will receive the AF program which include a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Each participant will receive an AliveCor mobile ECG cardiac monitor which is capable of providing real-time heart telemetry using a smart phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Diagnosis of paroxysmal AF (based on 12-lead electrocardiogram or event monitor showing AF).
- Body mass index of greater than 27 kg/m2
- Eligibility to participate in cardiac rehabilitation with negative exercise stress test within 6 months.
Key exclusion criteria (12 listed)
- Permanent AF.
- Undergone catheter ablation of AF in past 6 months.
- Class I or Class III anti-arrhythmic drugs at the time of enrollment
- Unable to participate in cardiac rehabilitation.
- Prognosis of less than 1-year.
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 |
|---|---|---|
| AliveCor mobile ECG cardiac monitorAliveCor mobile ECG cardiac monitor is capable of providing real-time heart telemetry using a smart phone. Participants will be instructed to transmit rhythm data twice weekly and during symptomatic AF. | Other | Intervention group 2, Standard of care group 1 |
| AF ProgramThe AF program includes a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Participants randomized to the intervention group 2 will undergo counseling by the nurse and guided through the structured, goal-directed AF program. Each participant will receive an AliveCor cardiac monitor which is capable of providing real-time heart telemetry using a smart phone. | Behavioural | Intervention group 2 |
| Standard of careGuideline-directed medical therapy according to clinical standard practice at Boston Medical Center. | Other | Standard of care group 1 |
Primary outcome
Feasibility of the AF program
Time frame: 6 months
Quantitative measure of willingness to enroll and attend nutrition clinic, cardiac rehabilitation clinic, and frequency of use of Alivecor device, smart Scale, Fitbit device will be aggregated to generate a single feasibility score to determine overall feasibility of the AF program. The feasibility score will be generated by the following formula: = 100 * average of { (actual nutrition clinic attendance/ expected nutrition clinic attendance) + (actual cardiac rehab clinic attendance/ expected cardiac rehab clinic attendance) + (actual use of smart phone enabled devices/expected use of smart phone enabled devices)} A feasibility score closer to 100% indicates good feasibility.
8 secondary outcomes
Acceptability of the AF program
Time frame: 6 months
Most acceptable individual component of the AF program
Time frame: 6 months
Most adopted individual component of the AF program
Time frame: 6 months
Burden of atrial fibrillation
Time frame: Twice weekly for 6 months
Atrial fibrillation symptoms
Time frame: 6 months
Atrial fibrillation literacy
Time frame: 6 months
Atrial Fibrillation Effect on Quality of Life
Time frame: 6 months
Hospitalization for atrial fibrillation
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Initially suspended due to COVID-19 policies, it will not be possible to restart.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Robert Helm, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AliveCor mobile ECG cardiac monitor and AF Program in people with Atrial Fibrillation and Risk Factors, run by Boston Medical Center 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 4 inclusion and 12 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 26 Jan 2021. 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?
The study was stopped early (reason given: Initially suspended due to COVID-19 policies, it will not be possible to restart.). Results are not available in the source record.
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?
Feasibility of the AF program (time frame: 6 months). 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 26 Jan 2021.