NCT Number: NCT06859060
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.
Trial opening soon.
Get Notified21 year and older
All sexes
Interventional
Not applicable
Mayagüez Medical Center Primary Care Psychology Clinic, Mayagüez, Puerto Rico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
A culturally adapted, multilevel intervention consisting of monthly 60-minute sessions over a 12-month period. Sessions will be conducted by graduate clinical psychology students acting as healthcare managers. The intervention focuses on care coordination, patient activation, and reducing provider stigma to improve access to preventive primary care services.
Participants will continue to receive standard psychiatric care, including routine visits with their mental health providers at the designated clinical sites. They will also receive a booklet with information on how best to link with primary care providers. This ensures that participants are aware of available resources and basic health care recommendations, but does not include any active follow-up or intervention components.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Five-item scale, used to assess severity of smoking.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Eliut Rivera-Segarra, PhD
CONTACT
Nelmit Tollinchi, PhD
CONTACT
Ponce Medical School Foundation, Inc.
Industry
Testing Bridges to Better Health and Wellness for People Living With Serious Mental Illness in Puerto Rico
Acronym: BRIDGES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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