Atrial FibrillationNCT03093558
Pilot Atrial Fibrillation Information Technology Trial
A study testing ECA/Kardia in people with Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
Trial summary
AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECA/Kardia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 30 Jun 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CHADS2-VASc score ≥2; English-speaking (at level appropriate to provide informed consent and participate in this research protocol); no plan to relocate from the area within 12 months of enrollment
Who cannot join
- AF that is due to non-cardiac causes (e.g., sepsis, pneumonia, thyroid disorders, and intoxication); AF within 30 days of any cardiothoracic or thoracic surgery; Inability to complete training session with the smartphone and demonstrate use of the ECA; Inability to answer specific protocol-based questions correctly during consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the Kardia (KAC) heart rhythm monitor.
Read the detailed description
This pilot study is a single-center, two-arm randomized study that by design is unblinded. 200 total participants are planned. Each participant will be randomized in an unblocked manner to receive "usual care" or the ECA/KAC intervention. Participants will have study visits at baseline and time 30 days. Adherence to using the ECA/KAC in combination over 30 days will be quantified. Following participation study participants randomized to the ECA/KAC intervention will undergo an interview to determine their experience with the ECA/KAC. Participants and their physicians will receive a summary of ECA use and symptoms and correlated findings by KAC.
- Conditions
- Atrial Fibrillation
- Being tested
- ECA/Kardia
- Keywords
- adherence, quality of life, health literacy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECA/KardiaBehavioural
Use of the ECA and Kardia daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Receive the ECA/Kardia for 30-day use. Receives: Behavioral: ECA/Kardia |
| Usual care arm | No intervention | Receive a journal for observation of adherence and symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor
Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor
Measured: 30 days
Secondary outcomes (1)
Participant experience of and response to using the ECA
Open- and close-ended questions regarding participant experience of the ECA and response to its use
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start21 Jun 2017
- Primary completion20 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jared W Magnani, MD, MSc, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093558
- Sponsor's protocol ID
- PRO16020290
- Status last verified
- Oct 2020
- First submitted
- 2 Mar 2017
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, IPD available by direct request to the PI.
Publications
Magnani JW, Schlusser CL, Kimani E, Rollman BL, Paasche-Orlow MK, Bickmore TW. The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment. JMIR Cardio. 2017 Jul-Dec;1(2):e7. doi: 10.2196/cardio.8543. Epub 2017 Dec 12.
PubMed 29473644Guhl E, Althouse AD, Pusateri AM, Kimani E, Paasche-Orlow MK, Bickmore TW, Magnani JW. The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation. JMIR Cardio. 2020 Sep 4;4(1):e17162. doi: 10.2196/17162.
PubMed 32886070Guhl EN, Schlusser CL, Henault LE, Bickmore TW, Kimani E, Paasche-Orlow MK, Magnani JW. Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT). Contemp Clin Trials. 2017 Nov;62:153-158. doi: 10.1016/j.cct.2017.09.005. Epub 2017 Sep 18.
PubMed 28923492
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Atrial Fibrillation Information Technology Trial
- ClinicalTrials.gov ID
- NCT03093558
- Acronym / sponsor ID
- PRO16020290
- Conditions
- Atrial Fibrillation
- Keywords
- adherence, quality of life, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 28 Mar 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.
AF is associated with significant social and medical costs, including diminished quality of life (QOL) and increased health care utilization (HCU). This pilot study will enroll 200 adults with prevalent, non-valvular AF of ≤3 year's duration at University of Pittsburgh Medical Center (UPMC). The primary objective at present is to obtain extensive feasibility and pilot data in implementing the Embodied Conversational Agent (ECA) in concert with the Kardia (KAC) heart rhythm monitor.
Detailed description
This pilot study is a single-center, two-arm randomized study that by design is unblinded. 200 total participants are planned. Each participant will be randomized in an unblocked manner to receive "usual care" or the ECA/KAC intervention. Participants will have study visits at baseline and time 30 days. Adherence to using the ECA/KAC in combination over 30 days will be quantified. Following participation study participants randomized to the ECA/KAC intervention will undergo an interview to determine their experience with the ECA/KAC. Participants and their physicians will receive a summary of ECA use and symptoms and correlated findings by KAC.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: ECA/KardiaReceive the ECA/Kardia for 30-day use. |
| Usual care arm | No intervention | –Receive a journal for observation of adherence and symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CHADS2-VASc score ≥2; English-speaking (at level appropriate to provide informed consent and participate in this research protocol); no plan to relocate from the area within 12 months of enrollment
Key exclusion criteria (1 listed)
- AF that is due to non-cardiac causes (e.g., sepsis, pneumonia, thyroid disorders, and intoxication); AF within 30 days of any cardiothoracic or thoracic surgery; Inability to complete training session with the smartphone and demonstrate use of the ECA; Inability to answer specific protocol-based questions correctly during consent.
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 |
|---|---|---|
| ECA/KardiaUse of the ECA and Kardia daily for 30 days. | Behavioural | Intervention arm |
Primary outcome
Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor
Time frame: 30 days
Assessment of daily use of the combined ECA and Kardia heart rate/rhythm monitor
1 secondary outcome
Participant experience of and response to using the ECA
Time frame: 30 days
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 30 Oct 2020.
- Results publication: PubMed 29473644Magnani JW, Schlusser CL, Kimani E, Rollman BL, Paasche-Orlow MK, Bickmore TW. The Atrial Fibrillation Health Literacy Information Technology System: Pilot Assessment. JMIR Cardio. 2017 Jul-Dec;1(2):e7. doi: 10.2196/cardio.8543. Epub 2017 Dec 12.
- Results publication: PubMed 32886070Guhl E, Althouse AD, Pusateri AM, Kimani E, Paasche-Orlow MK, Bickmore TW, Magnani JW. The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation. JMIR Cardio. 2020 Sep 4;4(1):e17162. doi: 10.2196/17162.
- Derived from this study: PubMed 28923492Guhl EN, Schlusser CL, Henault LE, Bickmore TW, Kimani E, Paasche-Orlow MK, Magnani JW. Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT). Contemp Clin Trials. 2017 Nov;62:153-158. doi: 10.1016/j.cct.2017.09.005. Epub 2017 Sep 18.
- Individual participant dataSharing planned: No. As this is a pilot study, IPD available by direct request to the PI.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA/Kardia in people with Atrial Fibrillation, run by University of Pittsburgh 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 1 inclusion and 1 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 30 Oct 2020. 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 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?
Daily adherence to the Embodied Conversational Agent and Kardia heart rhythm monitor (time frame: 30 days). 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 NCT03093558, which also lists 3 linked publications.
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 30 Oct 2020.