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E-Health Intervention for Type 2 Diabetes (LUNA-E Trial)

N/A

Recruiting

Led By Gregory A Talavera, MD/MPH

Research Sponsored by San Diego State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 2 diabetes with hemoglobin A1C (HbA1c) >8% in past 90 days

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post randomization

Awards & highlights

LUNA-E Trial Summary

This trial tests a team-based primary care intervention with E-Health to improve diabetes control and reduce psychological distress in Latinos.

Who is the study for?

This trial is for Hispanic/Latino adults with Type 2 diabetes and poor blood sugar control (HbA1c >8%). Participants must be registered at a qualifying health center, not in other diabetes programs, and have their doctor's approval. Exclusions include severe diabetes complications, current cancer or Parkinson's treatment, plans to move soon, severe health issues preventing consent, or being pregnant/nursing.Check my eligibility

What is being tested?

The LUNA-E study is testing a patient-centered care approach using virtual visits, coordinated care management, integrated medical and behavioral support alongside educational videos. This randomized trial aims to improve blood sugar levels and reduce psychological distress among participants.See study design

What are the potential side effects?

Since the interventions involve non-medical treatments like e-health services and education rather than drugs or invasive procedures, side effects are minimal but may include discomfort from increased attention to health status or anxiety about technology use.

LUNA-E Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My last HbA1c level was over 8%.

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I am 18 years old or older.

LUNA-E Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glycosylated hemoglobin A

Anxiety

Mental Depression

LUNA-E Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LUNA GroupExperimental Treatment4 Interventions

The LUNA Group is a culturally appropriate, E-Health enhanced, patient-centered, team-care model that includes: 1) care coordination by a Care Coordinator (CC) trained in electronic health records (EHR) clinical decision support and health promotion methods; 2) visits with a specially trained Behavioral Health Provider (BHP) with knowledge of diabetes and psychosocial aspects of diabetes; 3) care integration with primary care provider (PCP) implemented using the clinical decision support dashboard and/or synchronous communication during visits; and 4) a video adapted, evidence-based diabetes self-management education and support curriculum delivered through a learning management system.

Group II: Care CoordinationActive Control1 Intervention

The Care Coordination group applies the current methods of the federally qualified health center (FHQC) Patient Centered Medical Home initiative. Participants assigned to the care coordination group will continue with their regular medical visits with their primary care provider. In addition, they will receive care coordination and brief targeted health education provided by a specially trained medical assistant/care coordinator. This will involve 1 or more brief sessions with a care coordinator to provide health education, assist with appointments and referrals, and review medications. The care coordinator will work closely with their primary care provider. The care coordinator will also assist with referrals to behavioral health that may be initiated by the primary care provider.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

San Diego State UniversityLead Sponsor

153 Previous Clinical Trials

86,081 Total Patients Enrolled

Gregory A Talavera, MD/MPHPrincipal InvestigatorSan Diego State University

1 Previous Clinical Trials

456 Total Patients Enrolled

Linda C Gallo, PHDPrincipal InvestigatorSan Diego State University

Media Library

LUNA Behavioral Health Clinical Trial Eligibility Overview. Trial Name: NCT05570734 — N/A

Blood Sugar Control Research Study Groups: LUNA Group, Care Coordination

Blood Sugar Control Clinical Trial 2023: LUNA Behavioral Health Highlights & Side Effects. Trial Name: NCT05570734 — N/A

LUNA Behavioral Health 2023 Treatment Timeline for Medical Study. Trial Name: NCT05570734 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this experiment at present?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this trial is currently recruiting participants, with a listing date of February 27th 2023 and an update date of April 10th 2023. Four hundred individuals are needed to be enrolled from one medical centre in total."

Answered by AI

What is the current number of test subjects engaged in this medical research?

"Affirmative. According to the clinicaltrials.gov database, this medical research is presently seeking participants after being posted on February 27th 2023 and last updated on April 10th 2023. 400 volunteers are sought from one main study site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Latinos Understanding the Need for Adherence in Diabetes Using E-Health

Gregory Talavera 2023. "Latinos Understanding the Need for Adherence in Diabetes Using E-Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570734.