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Improving Medication Adherence in Post-ACS Patients

Primary Purpose

Medication Adherence, Acute Coronary Syndrome

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PST therapy

About this trial

This is an interventional supportive care trial for Medication Adherence focused on measuring medication adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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:

inability to communicate in English or Spanish
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 (including being unavailable by phone and/or traveling out of the country)
medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)
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.
deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours).
active psychosis, bipolar disorder, or any overt personality disorder

Sites / Locations

Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

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. 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.

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.

Outcomes

Primary Outcome Measures

Prevalence of medication adherence

Secondary Outcome Measures

Full Information

NCT ID

NCT00576160

First Posted

December 14, 2007

Last Updated

May 13, 2015

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00576160

Brief Title

Improving Medication Adherence in Post-ACS Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.

Study Start Date

August 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medication Adherence, Acute Coronary Syndrome

Keywords

medication adherence

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

PST therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Prevalence of medication adherence

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medical eligibility: Patient presenting for staged intervention with positive cardiac history OR Patient with stable CAD who received cardiac admission but does not report chest pain. OR Patient with stable CAD who has had a cardiac admission in the past. 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: inability to communicate in English or Spanish 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 (including being unavailable by phone and/or traveling out of the country) medically unable to receive aspirin (e.g. allergy, contra-indicated, etc) 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. deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours). active psychosis, bipolar disorder, or any overt personality disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karina W. Davidson, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

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Improving Medication Adherence in Post-ACS Patients

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