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Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)

10. juni 2019 opdateret af: Gregory Talavera, San Diego State University
The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions. LUNA-D focuses on diabetes management and behavioral health care integration.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes. LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases. Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm. The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination. Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education. Biological measurements will be taken at baseline, 3-, 6-, 9- and 12-months to detect changes in glycemic control. Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

456

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Chula Vista, California, Forenede Stater, 91910
        • South Bay Latino Research Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:

  • Self-identify as Hispanic/Latino
  • Be a registered & established patient of SYH
  • 18 years of age or older
  • Have an established diagnosis of T2DM (but not currently using insulin)
  • Not currently participating in any other diabetes or CVD intervention program
  • Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)

Exclusion Criteria:

Individuals will be excluded if they:

  • Are pregnant or planning to get pregnant (temporary exclusion, may qualify 6-months postpartum)
  • Have plans to move out of the area in the next 12 months
  • Have pre-existing health problems so severe as to prohibit informed consent and study attendance
  • Have severe diabetes, including renal disease and/or on dialysis
  • Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Special Intervention
The special intervention (SI) arm addresses glycemic control, medication adherence, control of modifiable CVD risk factors, health behavior change, and psychosocial and cultural barriers to self-management. The SI arm consists of a collaborative care team approach with four main elements including: 1) Specialized clinical care by a medical provider; 2) Specialized behavioral health care by a behavioral health provider; 3) Group-based chronic disease self-management education by peer-leaders; 4) Intensive, proactive care coordination facilitated by a patient registry and electronic health records.
Adfærdsmæssigt: Special Intervention
The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)
Andre navne:
  • Care Coordination
  • Medical Provider clinical visits
  • Behavioral Health Provider counseling visits
  • Group Health Education
Ingen indgriben: Usual Care
Participants randomized to the Usual Care (UC) arm continue to see their primary care provider and receive referrals to health education. At the discretion of the provider, UC patients are screened and referred to behavioral health (BH) care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c Blood Value
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
The primary outcome is change in HbA1c values among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Mass Index (BMI)
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Lower BMI among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Total Cholesterol
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Lower cholesterol levels among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Blood Pressure (BP)
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Improve the ratio of systolic to diastolic blood pressure among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Patient Health Questionnaire (PHQ-8)
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Improve depression symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Generalized Anxiety Disorder 7-item (GAD-7)
Tidsramme: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
Improve anxiety symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

San Diego State University

Efterforskere

  • Ledende efterforsker: Gregory A Talavera, MD/MPH, SDSU

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2015

Primær færdiggørelse (Faktiske)

18. december 2018

Studieafslutning (Faktiske)

31. december 2018

Datoer for studieregistrering

Først indsendt

7. juni 2019

Først indsendt, der opfyldte QC-kriterier

10. juni 2019

Først opslået (Faktiske)

12. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NR014866

Plan for individuelle deltagerdata (IPD)

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