Acute Coronary Syndrome, Medication Adherence
Conditions
Keywords
medication adherence
Brief summary
Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study will be enrolled into one of two groups. Patients in the first group will have their medication adherence measured, but will receive all other care as usual. Patients in the second group will also have their medication adherence measured, but they will receive telephone-delivered problem solving therapy (PST) in addition to their usual care. The two groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will improve by 20% (\<55% to \>75%).
Interventions
BEHAVIORALPST therapy
Problem-Solving Therapy (PST) is a behavioral approach that teaches patients how to systematically solve their own behavioral difficulties. During telephone treatment sessions, the patient will discuss the problems and difficulties they face and that give rise to medication non-adherence.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Medical eligibility: 1. Patient presenting for staged intervention with positive cardiac history OR 2. Patient with stable CAD who received cardiac admission but does not report chest pain. OR 3. Patient with stable CAD who has had a cardiac admission in the past. 2. Patient is non-adherent to prescribed medication. The following
Exclusion criteria
have been set for either safety concerns or concerns that patients will not be able to complete the protocol: 1. inability to communicate in English or Spanish 2. unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box 3. unavailability for the 1 month period of the study (including being unavailable by phone and/or traveling out of the country) 4. medically unable to receive aspirin (e.g. allergy, contra-indicated, etc) 5. deemed unable to comply with the protocol (either self selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia, and patients with current alcohol or substance abuse. 6. deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours). 7. active psychosis, bipolar disorder, or any overt personality disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of medication adherence | 30 days |
Countries
United States
Outcome results
None listed