- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723019
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being (Mi Puente)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Chula Vista, California, United States, 91910
- Scripps Mercy Chula Vista
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be Hispanic
- Must be ≥18 years
- Must have ≥2 cardiometabolic conditions (e.g., obesity, diabetes, hypertension, dyslipidemia ischemic heart diseases, congestive heart failure, other chronic coronary conditions)
- Must have ≥1 behavioral health concern(s) (i.e., related to mental health, life stressors, medication adherence, healthcare use)
- Must have telephone access
Exclusion Criteria:
- Pregnancy
- Serious life-threatening condition with life expectancy < 6 months
- Psychiatric morbidity or neurological/cognitive impairment of sufficient severity to preclude participation in the intervention
- Discharging to location other than home (e.g., nursing care)
- Does not speak Spanish or English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Volunteer Peer Mentor + Behavioral Health Nurse
|
Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
Other Names:
|
|
No Intervention: Control
Care as Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment
Time Frame: 30 days from baseline
|
Number of patients with at least one hospital readmission within 30 days after enrollment
|
30 days from baseline
|
|
Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment
Time Frame: 180 days from baseline
|
Number of patients with at least one hospital readmission within 180 days after enrollment
|
180 days from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome
Time Frame: 6 months from baseline
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome The minimum score on this scale is 10 and the maximum score on this scale is 50. A higher score on this scale means a better outcome. This measure provides an overall score of self-reported physical and mental health. |
6 months from baseline
|
|
Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome
Time Frame: 6 months from baseline
|
Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome The minimum score for this scale is 0 and the maximum score for this scale is 100. A higher score on this scale is more patient activation and is a better outcome. This measure provides an overall score of patient activation. |
6 months from baseline
|
|
Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome
Time Frame: 6 months from baseline
|
Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - short version - patient-reported outcome The minimum score is 1 and the maximum score is 5.
A higher score is a better outcome.
This measure provides an overall score of support for healthful lifestyle behaviors and self-management from multiple sources.
|
6 months from baseline
|
|
Number of Outpatient Visits Over the Past 6 Months - Patient-reported
Time Frame: 6 months from baseline
|
Number of Outpatient Visits Over the Past 6 Months - Patient-reported - Outpatient Healthcare Utilization This measure assesses outpatient healthcare utilization by capturing the number of self-reported outpatient visits completed in the past 6 months.
The minimum number of outpatient visits is 0. There is not set maximum.
A higher score is a better outcome.
|
6 months from baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Linda Gallo, PhD, San Diego State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NR015754-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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