Improving Medication Adherence in Post-ACS Patients - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00576160

Purpose

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%).

Condition	Intervention	Phase
Medication Adherence Acute Coronary Syndrome	Behavioral: PST therapy Behavioral: Usual Care	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT

Further study details as provided by Columbia University:

Primary Outcome Measures:

Medication adherence [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Participants will complete Baseline and 30-day assessment visit. At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed. A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin.	Behavioral: Usual Care Participants assigned to UCC will only receive the pre- and post-assessment session, and any adherence education or encouragement that is regularly provided by their treating physicians.
B: Experimental Participants will complete Baseline and 30-day assessment visit. At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed. A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin. After Baseline, there is an initial session telephone session with PST therapist. Subsequent treatment sessions provide a context for the patient to discuss the problems and difficulties they face and that give rise to medication non-adherence.	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.

Arms

Assigned Interventions

A: No Intervention

Participants will complete Baseline and 30-day assessment visit. At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed. A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin.

Behavioral: Usual Care

Participants assigned to UCC will only receive the pre- and post-assessment session, and any adherence education or encouragement that is regularly provided by their treating physicians.

B: Experimental

Participants will complete Baseline and 30-day assessment visit. At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed. A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin. After Baseline, there is an initial session telephone session with PST therapist. Subsequent treatment sessions provide a context for the patient to discuss the problems and difficulties they face and that give rise to medication non-adherence.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior enrollment in the related study "COPES Bedside - Pilot" (IRB-AAAB9286) and agreement to be contacted regarding additional studies.*
Patients reporting at 72 hours after discharge that they are not taking their prescribed aspirin medication will be considered to be eligible for this trial. Note that although the validity of positive self-reported adherence has been found to be poor, the validity of negative self-reported adherence has been found to be quite sensitive and specific.

Exclusion Criteria:

inability to communicate in English
no access to a telephone
unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box
unavailability for the 1 month period of the study
medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576160

Contacts

Contact: Karina W Davidson, PhD

212-342-4493

kd2124@columbia.edu

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Karina W Davidson, PhD 212-342-4493 kd2124@columbia.edu
Principal Investigator: Karina W Davidson, PhD

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Karina W. Davidson, PhD

Columbia University

More Information

Responsible Party:	Columbia University ( Karina Davidson/Associate Professor )
Study ID Numbers:	K24 HL084034, AAAB9215
Study First Received:	December 14, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00576160
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by Columbia University:

medication adherence

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Myocardial Ischemia

Acute Coronary Syndrome
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009