Atrial FibrillationNCT02690649
Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence
A study testing Health Messaging (Non-Procedural) in people with Atrial Fibrillation and Medication Adherence, run by Tammy Toscos at 1 site in United States.
Trial summary
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF). Outcomes of this work include a novel intervention, as well as information regarding patient preferences for tailored education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Medication Adherence
- What is being tested?
- Health Messaging (Non-Procedural)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2018
- 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
- Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)
- focus groups 1 \& 2: patients diagnosed ≤ 6 months
- focus groups 3 \& 4: patients diagnosed ≥ 6 months
- Receiving Oral Anticoagulation -Vitamin K Antagonist (VKA) or Novel Oral Anticoagulant (NOAC)- for non-valvular AF
- focus groups 1 \& 2: on VKA or NOAC
- focus groups 3 \& 4: changed VKA to NOAC within last 6 months
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- *Physically and Mentally capable of providing Informed Consent
- *Age 18 years or older
- *Ability to read and understand English
- Current Patient of Parkview Physicians Group (PPG)-Cardiology
- 3, 4, and 5 must apply to caregivers, partners, and/or support persons
- Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)
- Receiving Oral Anticoagulation (VKA or NOAC) for non-valvular AF
- Physically and Mentally capable of providing Informed Consent
- Age 18 years or older
- Access to Computer and Internet
- Ability to read and understand English
- Current Patient of PPG-Cardiology
- Willing to have a MyChart account
Who cannot join
- Absence of History of Atrial Fibrillation (AF)
- *Does not meet Inclusion Criteria
- Anticoagulation with VKA or NOAC for reasons other than non-valvular AF
- *Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently participating in another Parkview study that involves PHR use
- Only 2 and 4 apply to caregivers, partners, and/or support persons
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- TECHNOLOGY TRIAL:
- Absence of History of Atrial Fibrillation (AF)
- Does not meet Inclusion Criteria
- Anticoagulation with VKA or NOAC for reasons other than non-valvular AF
- Unable to physically or cognitively carry out the tasks necessary for utilizing a PHR such as; blindness, loss of function of arms, cognitive impairments (per chart review) that would interfere in learning a new task
- Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently participating in another Parkview study that involves PHR use
- Not willing to have a MyChart account
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkview Research Center; Parkview Health
Fort Wayne, Indiana, 46845
About this study
Official title: Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF). Outcomes of this work include a novel intervention, as well as information regarding patient preferences for tailored education.
Read the detailed description
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF). Outcomes of this work include a novel intervention, as well as information regarding patient preferences for tailored education.
There will be two phases in this study. In the first phase, the investigators will use a patient-centered approach to design and build a personal health record (PHR)-based educational intervention based on patient preferences for content, timing and delivery mechanism. In the second phase, the investigators will test the intervention in a six-month randomized controlled trial.
During the development of the intervention in Phase 1 the investigators will use a patient-centered, iterative design process that includes interviews, prototype development and testing. The investigators will recruit a diverse group of AF patients to determine preferences for information about AF and anticoagulant therapy. The investigators will use a user-centered design approach and best practices in human-computer interactions (HCI) to determine the desired content, timing, and delivery of tailored education in the PHR. The investigators will build out wire-frame models (low fidelity messaging prototypes) based on focus group findings to perform usability testing and further refine the intervention design. The intervention component will assess the impact of pushing tailored health education messages to patients through their PHR. The tailored health education will be specifically aimed at improving patient compliance with anticoagulant therapy.
One trigger for health education messaging will be failure to take, fill, or refill anticoagulant medication prescription - information obtained from an e-prescribing data feed to the electronic medical record (Surescripts) and use of a smart pill bottle (AdhereTech - HIPAA compliant, FDA-registered Class I medical device) that sends notification in real time when participants open or fail to open their pill bottle.
The intervention trial in Phase 2 will be comprised of two groups, control and experimental. Both the control and experimental group will receive standard care, which includes access to MyChart. In addition to standard care, both groups will receive training on the use of MyChart and the AdhereTech smart pill bottle, and medication adherence for both groups will be monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use. The experimental group will receive the intervention: tailored health messaging delivered via MyChart pertinent to AF and oral anticoagulant use.
- Conditions
- Atrial Fibrillation, Medication Adherence
- Being tested
- Health Messaging (Non-Procedural)
- Keywords
- anticoagulants, Personal Health Records
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Messaging (Non-Procedural)Other
Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle.
| Study group | Role | What they receive |
|---|---|---|
| Health Messaging (Non-Procedural) | Experimental | PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use.
Training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use. Receives: Other: Health Messaging (Non-Procedural) |
| No Health Messaging | No intervention | No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Standard care, training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken
Measured: 6 months during study
Secondary outcomes (3)
Patient Portal Login
The number of times participants logged into their patient portal (Epic's MyChart) during the study period was used as a proxy for patient engagement.
Measured: 6 months during study
Atrial Fibrillation Knowledge
End of study score on Atrial Fibrillation Knowledge scale (min:0 is no knowledge, max: 11 is high knowledge), adjusted for age, baseline knowledge, gender and education level.
Measured: 6 months
Number of Patients With Incidence of Adverse Events
Adverse events include death, stroke, any embolic event, and/or major bleeding.
Measured: 6 months during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionOct 2018
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tammy Toscos
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor-investigator, Tammy Toscos, Parkview Health
- Investigators
- Tammy Toscos, PhD, Principal investigator, Parkview Research Center; Parkview HealthMichael Mirro, MD, Principal investigator, Parkview Research Center; Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690649
- Sponsor's protocol ID
- PRC15-0709
- Status last verified
- Oct 2021
- First submitted
- 10 Feb 2016
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence for Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02690649
- Acronym / sponsor ID
- PRC15-0709
- Conditions
- Atrial Fibrillation, Medication Adherence
- Keywords
- anticoagulants, Personal Health Records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Tammy ToscosUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- Jan 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF). Outcomes of this work include a novel intervention, as well as information regarding patient preferences for tailored education.
Detailed description
This is an interventional study designed to develop patient focused strategies that improve adherence to anticoagulant medication in patients with non-valvular atrial fibrillation (AF). Outcomes of this work include a novel intervention, as well as information regarding patient preferences for tailored education.
There will be two phases in this study. In the first phase, the investigators will use a patient-centered approach to design and build a personal health record (PHR)-based educational intervention based on patient preferences for content, timing and delivery mechanism. In the second phase, the investigators will test the intervention in a six-month randomized controlled trial.
During the development of the intervention in Phase 1 the investigators will use a patient-centered, iterative design process that includes interviews, prototype development and testing. The investigators will recruit a diverse group of AF patients to determine preferences for information about AF and anticoagulant therapy. The investigators will use a user-centered design approach and best practices in human-computer interactions (HCI) to determine the desired content, timing, and delivery of tailored education in the PHR. The investigators will build out wire-frame models (low fidelity messaging prototypes) based on focus group findings to perform usability testing and further refine the intervention design. The intervention component will assess the impact of pushing tailored health education messages to patients through their PHR. The tailored health education will be specifically aimed at improving patient compliance with anticoagulant therapy.
One trigger for health education messaging will be failure to take, fill, or refill anticoagulant medication prescription - information obtained from an e-prescribing data feed to the electronic medical record (Surescripts) and use of a smart pill bottle (AdhereTech - HIPAA compliant, FDA-registered Class I medical device) that sends notification in real time when participants open or fail to open their pill bottle.
The intervention trial in Phase 2 will be comprised of two groups, control and experimental. Both the control and experimental group will receive standard care, which includes access to MyChart. In addition to standard care, both groups will receive training on the use of MyChart and the AdhereTech smart pill bottle, and medication adherence for both groups will be monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use. The experimental group will receive the intervention: tailored health messaging delivered via MyChart pertinent to AF and oral anticoagulant use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Messaging (Non-Procedural) | Experimental | Other: Health Messaging (Non-Procedural)PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use. |
| No Health Messaging | No intervention | –No PHR messaging of tailored health education pertinent to non-valvular atrial fibrillation and anticoagulant use. Standard care, training on the use of MyChart and the AdhereTech smart pill bottle, medication adherence monitored with Surescripts e-prescribing software and AdhereTech smart pill bottle use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosis of Atrial Fibrillation (Paroxysmal, Persistent, Permanent)
- Receiving Oral Anticoagulation -Vitamin K Antagonist (VKA) or Novel Oral Anticoagulant (NOAC)- for non-valvular AF
- *Physically and Mentally capable of providing Informed Consent
- *Age 18 years or older
- *Ability to read and understand English
Key exclusion criteria (14 listed)
- Absence of History of Atrial Fibrillation (AF)
- *Does not meet Inclusion Criteria
- Anticoagulation with VKA or NOAC for reasons other than non-valvular AF
- *Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
- Currently participating in another Parkview study that involves PHR use
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 |
|---|---|---|
| Health Messaging (Non-Procedural)Tailored health messaging delivered via the PHR MyChart pertinent to non-valvular atrial fibrillation and anticoagulant use. Messages will be triggered by medication non-adherence information obtained from Surescripts e-prescribing data and use of AdhereTech smart pill bottle. | Other | Health Messaging (Non-Procedural) |
Primary outcome
Medication Adherence
Time frame: 6 months during study
AdhereTech smart pill bottles used to collect medication dosing = percentage of allotted doses that were recorded as taken
3 secondary outcomes
Patient Portal Login
Time frame: 6 months during study
Atrial Fibrillation Knowledge
Time frame: 6 months
Number of Patients With Incidence of Adverse Events
Time frame: 6 months during study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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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.
Tammy Toscos, PhD principal investigator
Parkview Research Center; Parkview Health
Michael Mirro, MD principal investigator
Parkview Research Center; Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Messaging (Non-Procedural) in people with Atrial Fibrillation and Medication Adherence, run by Tammy Toscos 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 19 inclusion and 14 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 28 Oct 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?
Yes. Results are posted in the registry (first posted 28 Oct 2021). 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?
Medication Adherence (time frame: 6 months during study). 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 28 Oct 2021.