Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies

NCT ID: NCT06674616

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-06-30

Brief Summary

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In this trial, the investigators will examine the uptake of the evidenced-based IDEAL Goals program, a heart disease risk reduction program, while testing different implementation strategies with our partners in Michigan and Maryland who serve persons with serious mental illness (SMI).

Detailed Description

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In this trial, the investigators will work with Michigan and Maryland mental health programs to improve the uptake of the 18-month heart disease risk reduction program, IDEAL Goals, to be delivered to persons with SMI enrolled in their behavioral health homes.

Conditions

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Cardiovascular Risk Factors Serious Mental Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Replicating Effective Programs (REP)

Group Type ACTIVE_COMPARATOR

Replicating Effective Programs

Intervention Type OTHER

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

Replicating Effective Programs (REP) plus coaching

Group Type EXPERIMENTAL

Replicating Effective Programs

Intervention Type OTHER

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

Coaching

Intervention Type OTHER

Coaching is based on the Positive Behavior Interventions and Supports model, addresses staff barriers by building implementers' evidence-based practice (EBP) knowledge, self-efficacy, and skills through clinical support and feedback.

Replicating Effective Programs (REP) plus facilitation

Group Type EXPERIMENTAL

Replicating Effective Programs

Intervention Type OTHER

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

Facilitation

Intervention Type OTHER

Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.

Replicating Effective Programs (REP) plus coaching and facilitation

Group Type EXPERIMENTAL

Replicating Effective Programs

Intervention Type OTHER

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

Coaching

Intervention Type OTHER

Coaching is based on the Positive Behavior Interventions and Supports model, addresses staff barriers by building implementers' evidence-based practice (EBP) knowledge, self-efficacy, and skills through clinical support and feedback.

Facilitation

Intervention Type OTHER

Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.

Interventions

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Replicating Effective Programs

Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support

Intervention Type OTHER

Coaching

Coaching is based on the Positive Behavior Interventions and Supports model, addresses staff barriers by building implementers' evidence-based practice (EBP) knowledge, self-efficacy, and skills through clinical support and feedback.

Intervention Type OTHER

Facilitation

Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Ages 18 and Older
2. English Speaking
3. Agree to complete applicable data collection
4. Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail Daumit, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Yuan CT, Wang NY, Fink T, Almirall D, Appel LJ, Cook C, Cooper LA, Dalcin AT, Gennusa J, Goldsholl S, Kirley E, Liebrecht C, McGinty EE, Smith SN, Terry A, Kilbourne AM, Daumit GL. Achieving cardiovascular health equity in community mental health: study protocol for a cluster-randomized hybrid Type 3 effectiveness-implementation trial. Implement Sci. 2025 Oct 23;20(1):46. doi: 10.1186/s13012-025-01461-4.

Reference Type DERIVED
PMID: 41131632 (View on PubMed)

Other Identifiers

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UH3HL154280

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00410086

Identifier Type: -

Identifier Source: org_study_id

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