Type 2 Diabetes MellitusMi PuenteNCT02723019
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
A study testing Volunteer Peer Mentor+Behavioral Health Nurse in people with Type 2 Diabetes Mellitus and Cardiometabolic Conditions, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial summary
Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiometabolic Conditions, Behavioral Health Concerns
- What is being tested?
- Volunteer Peer Mentor+Behavioral Health Nurse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2016to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Mercy Chula Vista
Chula Vista, California, 91910
About this study
Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.
Read the detailed description
This study targets disparities in cardiometabolic disease prevalence and outcomes, and the unmet behavioral health needs in the US Hispanic population. Differences in the quantity and quality of health care targeted to and received by members of the Hispanic population contribute to these disparities. Inequities in health care access and use are likely the result of an interaction of several multi-level factors, such as those related to low Socio-Economic Status (e.g., lack of transportation or health coverage, time constraints, unsafe environments, knowledge barriers), cultural factors, language or communication-style differences, and others. Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente builds upon a sustainable nurse + volunteer peer team-based model and a strong collaborative, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). The program is guided by the Social Ecological Model,34 Resources and Support for Self-Management Model,35,36 and Transtheoretical Model of behavior change,37,38 and will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes. Ultimately the investigators seek to evaluate an effective, culturally appropriate, sustainable, and scalable program that addresses integrated health needs and reduces health disparities in Hispanics and other at-risk populations.
- Being tested
- Volunteer Peer Mentor+Behavioral Health Nurse
- Keywords
- Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care
- Medical subject headings
- Diabetes Mellitus, Type 2, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer Peer Mentor+Behavioral Health NurseBehavioural
Also called Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)
Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Volunteer Peer Mentor + Behavioral Health Nurse Receives: Behavioral: Volunteer Peer Mentor+Behavioral Health Nurse |
| Control | No intervention | Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment
Number of patients with at least one hospital readmission within 30 days after enrollment
Measured: 30 days from baseline
Number of Patients With at Least 1 Hospital Readmission Within 180 Days After Enrollment
Number of patients with at least one hospital readmission within 180 days after enrollment
Measured: 180 days from baseline
Secondary outcomes (4)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome
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.
Measured: 6 months from baseline
Patient Activation Measure (PAM) 13-Item - Patient-reported Outcome
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.
Measured: 6 months from baseline
Self-Management Resources for Chronic Disease, Chronic Illness Resources Survey (CIRS) - Short Version - Patient-reported Outcome
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.
Measured: 6 months from baseline
Number of Outpatient Visits Over the Past 6 Months - Patient-reported
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.
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study start14 Jul 2016
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes InstituteLinda Gallo, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723019
- Sponsor's protocol ID
- R01NR015754-01
- Acronym
- Mi Puente
- Status last verified
- Feb 2023
- First submitted
- 1 Dec 2015
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gallo LC, Fortmann AL, Clark TL, Roesch SC, Bravin JI, Spierling Bagsic SR, Sandoval H, Savin KL, Gilmer T, Talavera GA, Philis-Tsimikas A. Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial. J Gen Intern Med. 2023 Jul;38(9):2098-2106. doi: 10.1007/s11606-022-08006-1. Epub 2023 Jan 25.
PubMed 36697929Gallo LC, Fortmann AL, Bravin JI, Clark TL, Savin KL, Ledesma DL, Euyoque J, Sandoval H, Roesch SC, Gilmer T, Talavera GA, Philis-Tsimikas A. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):174. doi: 10.1186/s13063-019-3722-8.
PubMed 32051005
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mi Puente: My Bridge to Better Cardiometabolic Health and Well-Being
- ClinicalTrials.gov ID
- NCT02723019
- Acronym / sponsor ID
- Mi Puente / R01NR015754-01
- Keywords
- Hispanic Americans, Mental Health, Multimorbidity, Patient Readmission, Transitional Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- San Diego State University
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente utilizes a sustainable nurse + volunteer peer team-based model, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). Participants will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes.
Detailed description
This study targets disparities in cardiometabolic disease prevalence and outcomes, and the unmet behavioral health needs in the US Hispanic population. Differences in the quantity and quality of health care targeted to and received by members of the Hispanic population contribute to these disparities. Inequities in health care access and use are likely the result of an interaction of several multi-level factors, such as those related to low Socio-Economic Status (e.g., lack of transportation or health coverage, time constraints, unsafe environments, knowledge barriers), cultural factors, language or communication-style differences, and others. Mi Puente (or "My Bridge") is a culturally-tailored, interdisciplinary approach designed to support at-risk Hispanic patients and their caregivers pre- and post-hospital discharge as they navigate the multi-level barriers that contribute to inequities in health care access and use, and in turn, perpetuate disparities in cardiometabolic and behavioral health. Mi Puente builds upon a sustainable nurse + volunteer peer team-based model and a strong collaborative, bridging partnership between inpatient and outpatient care settings to meet the integrated (i.e., physical and behavioral) health needs of Hispanics who are hospitalized with multiple chronic cardiometabolic conditions and one or more behavioral health concern(s). The program is guided by the Social Ecological Model,34 Resources and Support for Self-Management Model,35,36 and Transtheoretical Model of behavior change,37,38 and will be tested at Scripps Mercy Hospital - a large, non-profit, safety net hospital located in the US/Mexico border region of South San Diego County, California. The proposed randomized controlled trial will test Mi Puente versus Usual Care (evidence-based, best practice discharge procedures) in improving hospital utilization, patient-reported, and cost effectiveness outcomes. Electronic medical records (EMR) will be used to identify eligible patients and examine primary outcomes. Ultimately the investigators seek to evaluate an effective, culturally appropriate, sustainable, and scalable program that addresses integrated health needs and reduces health disparities in Hispanics and other at-risk populations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Volunteer Peer Mentor+Behavioral Health NurseVolunteer Peer Mentor + Behavioral Health Nurse |
| Control | No intervention | –Care as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer Peer Mentor+Behavioral Health NurseAlso: Volunteer Peer Mentor (VPM) + Behavioral Health Nurse (BHN)Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse | Behavioural | Intervention Group |
Primary outcome
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
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
4 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Patient-reported Outcome
Time frame: 6 months from baseline
Patient Activation Measure (PAM) 13-Item - 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
Time frame: 6 months from baseline
Number of Outpatient Visits Over the Past 6 Months - Patient-reported
Time frame: 6 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36697929Gallo LC, Fortmann AL, Clark TL, Roesch SC, Bravin JI, Spierling Bagsic SR, Sandoval H, Savin KL, Gilmer T, Talavera GA, Philis-Tsimikas A. Mi Puente (My Bridge) Care Transitions Program for Hispanic/Latino Adults with Multimorbidity: Results of a Randomized Controlled Trial. J Gen Intern Med. 2023 Jul;38(9):2098-2106. doi: 10.1007/s11606-022-08006-1. Epub 2023 Jan 25.
- Derived from this study: PubMed 32051005Gallo LC, Fortmann AL, Bravin JI, Clark TL, Savin KL, Ledesma DL, Euyoque J, Sandoval H, Roesch SC, Gilmer T, Talavera GA, Philis-Tsimikas A. My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):174. doi: 10.1186/s13063-019-3722-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
Linda Gallo, PhD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer Peer Mentor+Behavioral Health Nurse in people with Type 2 Diabetes Mellitus and Cardiometabolic Conditions, run by Scripps Whittier Diabetes Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With at Least 1 Hospital Readmission Within 30 Days After Enrollment (time frame: 30 days from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723019, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.