NCT06461962

Brief Summary

The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Aug 2024Jun 2029

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

4.9 years

First QC Date

June 11, 2024

Last Update Submit

March 18, 2025

Conditions

Keywords

ScreeningImplementation ScienceHeart FailureAddictionStimulantsHealth ServicesCommunity Engaged Research

Outcome Measures

Primary Outcomes (1)

  • Linkage to cardiology care

    Proportion of participants who are engaged in cardiac care at 2 months after screening.

    2 months

Secondary Outcomes (2)

  • Linkage to diagnostic echocardiogram

    2 months

  • Goal Directed Medical Therapy (GDMT) prescribed

    6 months

Study Arms (2)

Peer-supported Treatment as Usual

ACTIVE COMPARATOR

Participants will receive a peer-supported referral to a local primary care provider who will create a plan to treat the participants heart failure.

Other: Treatment as Usual

Peer-Supported Telehealth Cardiology

EXPERIMENTAL

Participants will receive a virtual consultation with a cardiovascular specialist, referral for a locally performed echocardiogram (ECG), and transitional care management facilitated by a remote nurse care manager and the peer to treat the participants heart failure.

Other: Telehealth-Cardiology

Interventions

Peer-facilitated referral to a local primary care provider to follow-up their screening results.

Peer-supported Treatment as Usual

Peer-facilitated virtual consultation with cardiovascular specialist, for follow-up of their screening results. Activities may include: referral for a locally performed testing including echocardiogram and additional blood work, and transitional care management facilitated by a remote nurse care manager and the peer Referral for a locally performed testing including echocardiogram Transitional care management facilitated by a remote nurse care manager and the peer

Peer-Supported Telehealth Cardiology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient-defined regular use of methamphetamine in the last year
  • Any methamphetamine use in the past 30 days
  • Age 18 years or older
  • No client-reported diagnosis of heart failure
  • Able to communicate in English
  • Screen positive for potential methamphetamine-associated heart failure (MAHF) defined as B type natriuretic peptide (BNP) ≥50 pg/ml, or QRS width ≥120ms, or presence of any clinical heart failure symptoms

You may not qualify if:

  • Self-reported engagement in medical care for heart failure in past 6 months.
  • Actively taking medications for heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Heart FailureBehavior, Addictive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Brian Chan, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Chan, MD, MPH

CONTACT

Kellie Pertl, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

August 19, 2024

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified data may be shared following data lock with the data coordinating center at University of Washington.

Time Frame
Following data lock.

Locations