N/A N=160 Randomized Other

Keep it SIMPLE: Improving Anti-Coagulation Medication Adherence

Atrial Fibrillation · Medication Adherence

Bottom Line

View on ClinicalTrials.gov: NCT02690649 ↗

Enrolled (actual)

160

Serious AEs

4.4%

Results posted

Oct 2021

Primary outcome: Primary: Medication Adherence — 93.08; 89.52 percentage of doses recorded as taken — p=0.28

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Health Messaging (Non-Procedural) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tammy Toscos
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Medication Adherence	93.08; 89.52	0.28
SECONDARY Patient Portal Login	42.7; 15.9	<0.001 sig
SECONDARY Atrial Fibrillation Knowledge	7.31; 6.64	0.03 sig
SECONDARY Number of Patients With Incidence of Adverse Events	11; 6	—

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.

Eligibility Criteria

FOCUS GROUPS:

Inclusion Criteria

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
*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

Exclusion Criteria

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

TECHNOLOGY TRIAL:

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02690649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.