Clinical trial NCT06859060: Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico
Official title: Testing Bridges to Better Health and Wellness for People Living With Serious Mental Illness in Puerto Rico
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Disease
Serious Mental Illness
Keywords: Bridges
Stigma
Preventive Primary Care
Healthcare Managers
Wellness
Lead sponsor: Ponce Medical School Foundation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-03-05
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

Detailed description: BRIDGES is a multi-level Healthcare Manager Intervention (HMI) that addresses both patient and provider barriers to healthcare. It includes culturally adapted modules to reduce stigma and promote chronic disease prevention. The study uses a hybrid type 1 effectiveness-implementation randomised controlled trial to test its impact on primary care service use, chronic disease outcomes and stigma reduction over 12 months.

Eligibility criteria: Inclusion criteria:

Adults receiving psychiatric or psychological services at the Wellness Center or the Mayaguez Medical Center - Primary Care Diagnosed with at least one serious mental illness SMI (e.g., schizophrenia, bipolar disorder, major depression, etc.) Have at least one risk factor or a diagnosis of a chronic health condition (e.g., diabetes, overweight, hypertension, etc.).

Be willing to receive or continue preventive medical care with a primary care physician.

Exclusion criteria:

Have started psychiatric or mental health services at least one month before Have been diagnosed with a general mental health condition (e.g., Depression or Anxiety).

Primary outcomes:
measure: Recipt of Preventive Primary Care
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Lipid Panel
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Basic Metabolic Panel
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Smoking - Severity Dependence Scale
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Physical Activity - International Physical Activity Questionnaire
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Health Literacy - Test of Functional Health Literacy for Adults
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Self-Stigma - Self-Stigma of Mental Illness Scale
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Provider Stigma - The Mental Health Stigma Scale for Health Professionals
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
measure: Patient-Provider Relationship - Patient Assessment of Chronic Illness Care
timeFrame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Other outcomes:
Locations:
city: Mayagüez
country: Puerto Rico
facility: Mayagüez Medical Center Primary Care Psychology Clinic
city: Ponce
country: Puerto Rico
facility: PHSU Wellness Center
Study officials:
References: