Cardiovascular Risk FactorsNCT06674616
Reducing Disparities in Cardiovascular Health in Community Mental Health Settings: Optimizing Implementation Strategies
A study testing Replicating Effective Programs, Coaching and Facilitation in people with Cardiovascular Risk Factors and Serious Mental Illness, run by Johns Hopkins University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Serious Mental Illness
- What is being tested?
- Replicating Effective Programs, Coaching and Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 and Older
- English Speaking
- Agree to complete applicable data collection
- Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University
Baltimore, Maryland, 21287
About this study
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).
Read the detailed description
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.
- Being tested
- Replicating Effective Programs, Coaching, Facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replicating Effective ProgramsOther
Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support
CoachingOther
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.
FacilitationOther
Facilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.
| Study group | Role | What they receive |
|---|---|---|
| Replicating Effective Programs (REP) | Active comparator | Not described Receives: Other: Replicating Effective Programs |
| Replicating Effective Programs (REP) plus coaching | Experimental | Not described Receives: Other: Replicating Effective Programs; Other: Coaching |
| Replicating Effective Programs (REP) plus facilitation | Experimental | Not described Receives: Other: Replicating Effective Programs; Other: Facilitation |
| Replicating Effective Programs (REP) plus coaching and facilitation | Experimental | Not described Receives: Other: Replicating Effective Programs; Other: Coaching; Other: Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
Main effects of implementation strategies defined as those who attend sessions that are assigned to the most intensive strategies (Replicating Effective Programs (REP), Coaching, and Facilitation) compared to the least intensive (REP only). The investigators will use electronic health record data on all clients enrolled in the behavioral health home at a participating organization to assess sessions attended. These individuals are not formally enrolled into the trial; their data, obtained under a waiver of informed consent, comprise this outcome.
Measured: baseline to 18 months
Secondary outcomes (1)
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
Marginal effects of implementation strategies defined as those who attend sessions that are assigned to Coaching or Facilitation compared to those not assigned to that same strategy.
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start7 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gail Daumit, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674616
- Sponsor's protocol ID
- IRB00410086
- Other IDs
- UH3HL154280
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow NHLBI guidelines.
Publications
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.
PubMed 41131632
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Cardiovascular Health in Community Mental Health Settings: Optimizing Implementation Strategies
- ClinicalTrials.gov ID
- NCT06674616
- Acronym / sponsor ID
- IRB00410086
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- 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.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Replicating Effective Programs (REP) | Active comparator | Other: Replicating Effective Programs |
| Replicating Effective Programs (REP) plus coaching | Experimental | Other: Replicating Effective Programs, Other: Coaching |
| Replicating Effective Programs (REP) plus facilitation | Experimental | Other: Replicating Effective Programs, Other: Facilitation |
| Replicating Effective Programs (REP) plus coaching and facilitation | Experimental | Other: Replicating Effective Programs, Other: Coaching, Other: Facilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 and Older
- English Speaking
- Agree to complete applicable data collection
- Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).
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 |
|---|---|---|
| Replicating Effective ProgramsReplicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support | Other | Replicating Effective Programs (REP), Replicating Effective Programs (REP) plus coaching, Replicating Effective Programs (REP) plus coaching and facilitation, Replicating Effective Programs (REP) plus facilitation |
| CoachingCoaching 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. | Other | Replicating Effective Programs (REP) plus coaching, Replicating Effective Programs (REP) plus coaching and facilitation |
| FacilitationFacilitation addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff. | Other | Replicating Effective Programs (REP) plus coaching and facilitation, Replicating Effective Programs (REP) plus facilitation |
Primary outcome
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
Time frame: baseline to 18 months
Main effects of implementation strategies defined as those who attend sessions that are assigned to the most intensive strategies (Replicating Effective Programs (REP), Coaching, and Facilitation) compared to the least intensive (REP only). The investigators will use electronic health record data on all clients enrolled in the behavioral health home at a participating organization to assess sessions attended. These individuals are not formally enrolled into the trial; their data, obtained under a waiver of informed consent, comprise this outcome.
1 secondary outcome
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program
Time frame: baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 41131632Yuan 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.
- Individual participant dataSharing planned: Yes. We will follow NHLBI guidelines.
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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.
Gail Daumit, MD, MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replicating Effective Programs, Coaching and Facilitation in people with Cardiovascular Risk Factors and Serious Mental Illness, run by Johns Hopkins University at 2 sites 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 4 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: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of IDEAL Goals sessions received by persons with serious mental illness (SMI) at the community mental health program (time frame: baseline to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674616, which also lists 1 linked publication.
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 12 Jun 2026.