Health TrialsbyHealthPanel

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

ConditionsType 2 DiabetesGlycemic ControlPsychological Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Diego State University

About this trial

Latinos Understanding the Need for Adherence in Diabetes using Care Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) is a randomized controlled trial (RCT) that will test the effectiveness a patient-centered, team-based, primary care intervention with E-Health enhancements in improving glycemic control (primary outcome, hemoglobin A1C level) and psychological distress (secondary outcome; depression, anxiety symptoms).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Self identify as Hispanic/Latino ethnicity of any race

Registered patient of federally qualified health center

18 years of age or older

Type 2 diabetes with hemoglobin A1C (HbA1c) >7.5% in past 90 days

Disqualifiers

Actively being treated for cancer or Parkinson's Disease

Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum)

Have plans to move out of the area in the next 12 months

Have other existing mental or physical health problems so severe as to prohibit informed consent and participation

Trial design

Design model

Parallel

Treatments tested in this trial

  • LUNA Care Coordination

    Behavioral

    Participants in this group will have 6 or more 30-minute care coordination sessions with the LUNA Care Coordinator. The LUNA Care Coordinator will assist with appointments and referrals, medications, and assist with accessing the health education videos. They will work closely with the participant's primary care provider and the LUNA Behavioral Health Provider.

  • LUNA Behavioral Health

    Behavioral

    Participants in this group will have 6 or more 30-minute behavioral health sessions with the LUNA Behavioral Health Provider. The LUNA Behavioral Health Provider will screen and address life stressors, social support, and health care use. The purpose of these sessions is to check on participant's progress with their care plan. The behavioral health sessions will involve discussion of issues that may interfere with optimal diabetes self-management. The LUNA Behavioral Health Provider will help participants overcome any potential barriers to managing their diabetes by setting goals and helping to address life stress or other issues that may be interfering with their diabetes self-management.

  • Health Education Videos

    Behavioral

    Participants in this group will have access to eight 20 to 30-minute health education video sessions with corresponding print material and activities to reinforce what they learn. The health education videos focus on medication adherence, self-monitoring, stress and coping, nutrition, physical activity and culturally driven beliefs and values.

  • Virtual Integrated Visits

    Behavioral

    Participants in this group will have two virtual integrated visits with the LUNA care team. Through video conferencing, they will meet at the same time with the LUNA Care Coordinator, the LUNA Behavioral Health Provider, and their primary care provider to ensure an integrated care plan.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: LUNA GroupExperimental treatment 4 interventions
Group B: Care CoordinationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin A1C (HbA1c) Blood Value

Change glycemic control among Latino patients with type 2 diabetes through an innovative patient centered, team-based, highly integrated primary care intervention (LUNA-E).

Time frame
6-months post randomization
2

Psychological Distress - Depression

Change psychological distress (depression symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Personal Health Questionnaire-8 (PHQ-8) will be used to assess depression symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-24) with higher scores indicating more severe depression symptoms.

Time frame
6-months post randomization
3

Psychological Distress - Anxiety

Change psychological distress (anxiety symptoms) among Latino patients with type 2 diabetes via the LUNA-E intervention. The Generalized Anxiety Disorder Questionnaire (GAD-7) will be used to measure anxiety symptomatology. Response options range from not at all (0) to nearly every day (3). Item scores are summed (range 0-21) with higher scores indicating more severe anxiety symptoms.

Time frame
6-months post randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Diego State University

Lead sponsor

Source ClinicalTrials.gov
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