An interventional study of Replicating Effective Programs and Coaching in Cardiovascular Risk Factors and Serious Mental Illness, sponsored by Johns Hopkins University. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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).
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Community Mental Health Program site staff participants:
Inclusion Criteria
Other: Replicating Effective Programs
Other: Replicating Effective Programs · Other: Coaching
Other: Replicating Effective Programs · Other: Facilitation
Other: Replicating Effective Programs · Other: Coaching · Other: Facilitation
Replicating Effective Programs (REP), based on Social Learning Theory and Rogers' Diffusion of Innovations, incorporates program packaging, training, and technical support
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 addresses potential organizational barriers to delivery, including leadership support and acceptance among other staff.
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.
Time frame: baseline to 18 months
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.
Time frame: baseline to 18 months
Number of IDEAL Goals sessions received by persons with SMI at the community mental health program at 30 Months (Exploratory)
Number of sessions received at 30 months
Time frame: baseline to 30 months
Proportion of visits with recommended tobacco smoking activities (e.g. assessment, counseling if smoker, pharmacotherapy offered if smoker) (Exploratory)
Time frame: baseline to 18 months, 30 months
Proportion of visits with recommended hypertension activities (e.g. screening, monitoring if have hypertension, medication modification as appropriate) (Exploratory)
Time frame: baseline to 18 months, 30 months
Proportion of visits with recommended diabetes activities (e.g. screening, monitoring if have diabetes, screening exams if have diabetes, medication modification as appropriate) (Exploratory)
Time frame: baseline to 18 months, 30 months
Proportion of visits with recommended dyslipidemia activities (e.g. screening, monitoring if have dyslipidemia, medication modification as appropriate ) (Exploratory)
Time frame: baseline to 18 months, 30 months
Proportion of visits with recommended weight management activities (e.g. counseling) (Exploratory)
Time frame: baseline to 18 months, 30 months
Self-reported tobacco use among persons with SMI at the community mental health program (Exploratory)
proportion with self-reported tobacco use recorded by staff in electronic health record
Time frame: baseline to 18 months, 30 months
Blood pressure (systolic and diastolic) in mmHG among persons with SMI at the community mental health program (Exploratory)
Time frame: baseline to 18 months, 30 months
HgbA1c level among persons with SMI at the community mental health program. (Exploratory)
Time frame: baseline to 18 months, 30 months
Lipid values among persons with SMI at the community mental health program (Exploratory)
low density lipoprotein (LDL) mg/dl, high density lipoprotein (HDL) mg/dl,, triglycerides mg/dl, and total cholesterol mg/dl,
Time frame: baseline to 18 months, 30 months
BMI (kg/m^2) among persons with SMI at the community mental health program pre and post implementation. (Exploratory)
BMI in kg/m\^2 based on measured weight in kg and height in meters
Time frame: baseline to 18 months, 30 months
Cardiovascular risk in persons with SMI at community mental health programs (Exploratory)
American Heart Association (AHA) American College of Cardiology Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score, percent risk, higher scores convey more risk
Time frame: baseline to 18 months, 30 months
Estimated cost of delivering the IDEAL Goals program and implementation strategies (Exploratory)
Time frame: baseline to 18 months
Plan to share: Yes — We will follow NHLBI guidelines.
Supporting information: Study protocol
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