Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Improving Medication Adherence in Post-ACS Patients

This study has been terminated.
(This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karina Davidson, Columbia University
ClinicalTrials.gov Identifier:
NCT00576160
First received: December 14, 2007
Last updated: May 30, 2012
Last verified: May 2012
  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 1

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

Enrollment: 22
Study Start Date: September 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
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.
Experimental: B
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Karina W. Davidson, PhD Columbia University
  More Information

No publications provided

Responsible Party: Karina Davidson, Professor of Medicine in Psychiatry, Columbia University
ClinicalTrials.gov Identifier: NCT00576160     History of Changes
Other Study ID Numbers: AAAB9215, K24HL084034
Study First Received: December 14, 2007
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Columbia University:
medication adherence

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014