Improving Health and Wellness for People with Serious Mental Illness in Puerto Rico

Not Applicable

Not yet recruiting

• Conditions: Chronic Disease; Serious Mental Illness

• Registration Number: NCT06859060
• Lead Sponsor: Ponce Medical School Foundation, Inc.

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-08
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recipt of Preventive Primary Care	baseline,6 and 12 months follow up and 6 and 12 months post intervention	29-item questionnaire developed by team members. It uses preventive primary care indicators from the US Preventive Service Task Force Guidelines extracted from medical records and examines the use of physical health services over the past 6-months.Indicators are grouped into six categories: physical examinations, screenings for women, screenings for men, laboratory tests, vaccinations, and education. An aggregate preventive primary score is calculated representing the proportion of services for which each participant was eligible depending on age and gender.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	baseline,6 and 12 months follow up and 6 and 12 months post intervention	The A1C test is a simple common blood test used to measure blood sugar levels over the past 3 months.
Lipid Panel	baseline,6 and 12 months follow up and 6 and 12 months post intervention	The Lipid panel is a simple common blood test used to examine cardiovascular health by analyzing cholesterol in the blood. This test examines four types of lipids in the blood, namely: 1) Total cholesterol, 2 Low-density lipoprotein (LDL), 3) High-density lipoprotein (HDL), and 4) Triglycerides.
Basic Metabolic Panel	baseline,6 and 12 months follow up and 6 and 12 months post intervention	It is a simple common blood group of tests used to examine different naturally occurring chemicals in the blood. The tests can give information heart, kidneys, and liver function. It includes Blood urine nitrogen (BUN), carbon dioxide (C02), Creatinine, Glucose, Serum chloride, Serum potassium, Serum sodium, and Serum Calcium.
Smoking - Severity Dependence Scale	baseline,6 and 12 months follow up and 6 and 12 months post intervention	Five-item scale, used to assess severity of smoking.
Physical Activity - International Physical Activity Questionnaire	baseline,6 and 12 months follow up and 6 and 12 months post intervention	This is a 7-item measure widely used to examine 4 types of physical activity: 1) vigorous, 2) moderate, 3) walking and 4) sitting.
Health Literacy - Test of Functional Health Literacy for Adults	baseline,6 and 12 months follow up and 6 and 12 months post intervention	Questionnaire with 12 items measuring adult functional health literacy in the health care setting.
Self-Stigma - Self-Stigma of Mental Illness Scale	baseline,6 and 12 months follow up and 6 and 12 months post intervention	This 40-item measure examines self stigma's four dimensions (awareness, agreement, self-application and self esteem).
Provider Stigma - The Mental Health Stigma Scale for Health Professionals	baseline,6 and 12 months follow up and 6 and 12 months post intervention	12-item measure examining provider stigma dimensions (social distance, negative character attributions and self-sufficiency).
Patient-Provider Relationship - Patient Assessment of Chronic Illness Care	baseline,6 and 12 months follow up and 6 and 12 months post intervention	20-item scale used to assess participants' perspectives on the quality and patient-centeredness of chronic illness care received during the past 6 months from their primary care provider.

Trial Locations

Locations (2)

Mayagüez Medical Center Primary Care Psychology Clinic; 🇵🇷 Mayagüez, Puerto Rico

PHSU Wellness Center; 🇵🇷 Ponce, Puerto Rico