Medication Adherence Intervention for Myocardial Ischemia and Rheumatic Diseases

(SEPPRMACI-ARM Trial)

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Statins, Beta-blockers, DMARDs

Disqualifiers: Nursing home, Impaired decision, Prisoners, Pregnant, Terminally ill, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with ischemic heart disease (IHD) and rheumatic diseases in adhering to their medication plans. It focuses on those who have recently undergone a heart procedure called PCI or are beginning anti-rheumatic medications. The trial tests an intervention called VA SEPPRMACI-ARM, which uses personalized text messages, phone calls, and one-on-one support to remind patients to refill and take their medications on time. Veterans receiving care from the VA and taking specific heart or rheumatic medications may be well-suited for this trial. As an unphased trial, it offers Veterans a unique opportunity to enhance their medication adherence through personalized support.

Do I have to stop taking my current medications for this trial?

The trial does not specify that you need to stop taking your current medications. It focuses on improving adherence to certain medications for heart disease and rheumatic conditions, so you will likely continue your current treatment.

What prior data suggests that this medication adherence intervention is safe for Veterans with IHD and rheumatic diseases?

Research shows that the VA SEPPRMACI-ARM program helps people take their medications as prescribed by using technology like text messages and phone calls. This method is very safe because it doesn't involve new drugs or medical procedures. Instead, it focuses on reminding patients to take their medications correctly.

The program is low-risk because it centers on communication and support to help patients follow their medication schedules. No reports of negative effects have emerged from this type of program, and most people find it easy to use because it helps them manage their current treatments better.

The trial is labeled as "Not Applicable" for its phase, indicating that safety isn't a major concern as it would be for a new drug or surgery. The main goal is to assess how well it helps patients with their medication routines without adding new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medication Adherence Intervention for Myocardial Ischemia and Rheumatic Diseases because it aims to improve how patients stick to their medication regimens, which is often a challenge with these conditions. Unlike standard treatments that focus solely on the physical symptoms, this intervention targets behavior and adherence, potentially leading to better long-term health outcomes. By helping patients follow their prescribed therapies more consistently, this approach could reduce the risk of complications and improve overall quality of life.

What evidence suggests that this medication adherence intervention is effective for improving cardiac health in Veterans with IHD?

Research shows that taking medication as prescribed can greatly improve health for people with ischemic heart disease (IHD). Studies have found that programs designed to help people take their medication correctly can lead to better health, reducing the risk of serious problems like heart attacks or cardiac death. For example, a review of several studies found that these programs generally help people take their medication more regularly, which improves their overall health. Not taking medication as directed links to worse health outcomes, so it's important for patients to follow their medication plans. In this trial, the VA SEPPRMACI-ARM strategy, which uses personalized messages and phone calls to support patients in sticking to their medication schedules, is being tested in the experimental group. This approach aims to improve heart health and manage rheumatic diseases more effectively. ^{4 6 7 8 9}

Who Is on the Research Team?

Liron Caplan, MD PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for Veterans with ischemic heart disease who've had a PCI or are starting anti-rheumatic medication. They must be taking specific meds, get care from the VA, and have a VA-assigned primary care provider. It's not for those only diagnosed via catheterization, prisoners, pregnant women, terminally ill patients, those using non-VA medicine sources or in nursing facilities, or individuals with impaired decision-making.

Inclusion Criteria

You have had a procedure called PCI or are taking a type of medication called DMARD.

You are taking certain medications for heart disease or rheumatoid arthritis.

Patients who receive their care from the VA, as defined by the presence of a VA-assigned-PCP in the specified time frames

Exclusion Criteria

People who are very sick and not expected to get better.

Prisoners

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-faceted patient-centered intervention to improve medication adherence, including SMS, IVR, and contact with a trained interventionalist.

1 year

Follow-up

Participants are monitored for cardiovascular events and medication adherence effectiveness after the intervention.

1 year

Cost Effectiveness Analysis

Establish the cost to implement and maintain the intervention and assess incremental cost effectiveness.

through study completion, an average of 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Caplan IVR
• VA SEPPRMACI-ARM

Trial Overview

The study tests an adherence intervention called VA SEPPRMACI-ARM to improve how well Veterans with IHD follow their medication plans after PCI or when starting anti-rheumatic drugs. It uses personalized texts and calls to remind patients about refills and escalates to personal contact if they miss doses.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

This group will undergo the intervention as described in the protocol

Group II: Control Group Active Control 1 Intervention

This group will not receive the intervention, they will receive usual care

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT02694185

Secondary Event Prevention Using Population Risk ...

This Myocardial Ischemia and Rheumatic Diseases study at UCSF ends February 2025.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7284284/

Interventions supporting long term adherence and decreasing ...

Co-primary outcomes were completion of cardiac rehabilitation and adherence to recommended medication. Data were collected by blinded assessors ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4826853/

The Effectiveness of Medication Adherence Interventions ...

The purpose of this meta-analysis was to determine the overall effectiveness of interventions designed to improve medication adherence (MA) among adults with ...

4.

amjmed.com

amjmed.com/article/S0002-9343(12)00018-6/fulltext

Adherence to Drugs That Prevent Cardiovascular Disease

The summary estimate for adherence across all studies was 57% (95% confidence interval [CI], 50-64) after a median of 24 months. There were ...

5.

dukespace.lib.duke.edu

dukespace.lib.duke.edu/bitstreams/5a5c8e82-e5b8-4853-b829-f8b5eb406bd1/download

Patient-Centered Adherence Intervention After Acute ...

The study will assess the effectiveness of the intervention (1) to improve adherence to cardioprotective medications (ie, β-blockers, statins, clopidogrel, and ...

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/89/NCT01975389/Prot_000.pdf

phase 3 multi-center, double-blind, randomized

The summary of safety for completed studies with bococizumab was updated to reflect the updated Phase 2 anti-drug anti-body data based on a more ...

7.

researchgate.net

researchgate.net/publication/396144510_Complete_Revascularization_in_Patients_with_Acute_Myocardial_Infarction_and_Multivessel_Disease_Pooled_Analysis_of_Kaplan-Meier-Derived_Individual-Patient-Data

Pooled Analysis of Kaplan-Meier-Derived Individual ...

Improved outcomes in patients with ST-elevation myocardial infarction ... ischemic burden on myocardial perfusion scintigraphy or in the safety ...

8.

journals.lww.com

journals.lww.com/cd/fulltext/2022/12000/emerging_treatment_approaches_to_improve_outcomes.4.aspx

Emerging Treatment Approaches to Improve Outcomes in...

This article presents the rationale for the use of each of these 4 new classes of drugs, reviews the results from pivotal clinical trials showing their safety ...

9.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf10/P100023S015c.pdf

Sterile Barrier Pouch

The primary endpoint is in-stent late loss by QCA on 9-month follow-up (ION Stent compared to bare metal Express Stent) and the secondary endpoint Is target ...