Improving Medication Adherence in Post-ACS Patients

Acute Coronary Syndrome Clinical Trial

Official title:

Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00576160
• Other study ID #: AAAB9215
• Secondary ID: K24HL084034
• Status: Terminated
• Phase: Phase 1
• First received: December 14, 2007
• Last updated: May 13, 2015
• Start date: August 2007
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Medication Adherence

Intervention

Behavioral:
• PST 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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of medication adherence		30 days	Yes