Medication AdherencePhase 1NCT00576160
Improving Medication Adherence in Post-ACS Patients
A Phase 1 study testing PST therapy in people with Medication Adherence and Acute Coronary Syndrome, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Acute Coronary Syndrome
- What is being tested?
- PST therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
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%).
- Conditions
- Medication Adherence, Acute Coronary Syndrome
- Being tested
- PST therapy
- Keywords
- medication adherence
- Medical subject headings
- Medication Adherence, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PST therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. 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. Receives: Behavioral: PST therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of medication adherence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Karina Davidson, Columbia University
- Investigators
- Karina W. Davidson, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576160
- Sponsor's protocol ID
- AAAB9215
- Other IDs
- K24HL084034
- Status last verified
- May 2015
- First submitted
- 14 Dec 2007
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
- ClinicalTrials.gov ID
- NCT00576160
- Acronym / sponsor ID
- AAAB9215
- Conditions
- Medication Adherence, Acute Coronary Syndrome
- Keywords
- medication adherence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. 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 | Behavioral: PST therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Medical eligibility:
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PST therapyProblem-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. | Behavioural | B |
Primary outcome
Prevalence of medication adherence
Time frame: 30 days
Results and safety
The study was stopped early (reason given: This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina W. Davidson, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PST therapy in people with Medication Adherence and Acute Coronary Syndrome, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This was a dosing study to determine acceptability. Participants found protocol burdensome and so we terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of medication adherence (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.