- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03627377
Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS)
Multi-component Intervention for Diabetes in Adults With Serious Mental Illness (MIDAS)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dilip V Jeste, MD
- Telefonnummer: (858) 534-4020
- E-mail: djeste@ucsd.edu
Undersøgelse Kontakt Backup
- Navn: Danielle K Glorioso, LCSW
- Telefonnummer: (858) 246-0767
- E-mail: dglorioso@ucsd.edu
Studiesteder
-
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California
-
La Jolla, California, Forenede Stater, 92093
- Rekruttering
- University of California, San Diego Division of Geriatric Psychiatry
-
Kontakt:
- Danielle K Glorioso, LCSW
- Telefonnummer: 858-246-0767
- E-mail: dglorioso@ucsd.edu
-
Kontakt:
- Cynthia Ibarra, MA
- Telefonnummer: (858) 822-6005
- E-mail: cyibarra@ucsd.edu
-
Ledende efterforsker:
- Dilip V Jeste, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Participants: A total of 12 RCFs (30 to 45 beds each), 210 resident participants, and 120 staff members (1 manager, 2 activity directors, 1 cook, and 6 other staff members per facility) will be enrolled.
Inclusion and Exclusion Criteria:
Residential Care Facilities (RCFs):
Inclusion Criteria:
- Licensed by California Division of Social Services' Community Care Licensing
- Serves only individuals with SMI
- Has >15 residents currently living in the facility
- Willing to participate
Staff Participants:
Inclusion Criteria:
- Age >21 years
- Fluent in English
- Written informed consent to participate
Exclusion Criteria:
(1) Plans to leave the RCF during the next year.
Resident Participants:
Inclusion Criteria:
- Age 18 - 65 years
- Chart diagnosis of an SMI, mainly schizophrenia, schizoaffective disorder, or bipolar disorder
- Current treatment with antipsychotics
- Fluent in English
- Written informed consent to participate in this study
Exclusion Criteria:
- Chart diagnosis of dementia or intellectual disability disorder
- Active substance abuse (non-tobacco)
- Medical problems that interfere with ability to complete assessments and intervention
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control Phase
3-month initial control phase (no intervention, month 1-3)
|
|
Eksperimentel: Intervention Phase
6-month intervention phase - MIDAS Intervention Delivered.
Followed by 6-month follow-up phase (no intervention, months 10-15).
|
Main components of MIDAS include: (1) Education about diabetes and lifestyle, (2) Dietary intervention at the facility and resident level, (3) Increased physical activity, and (4) Smoking cessation / reduction.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Body Mass Index (BMI in kg/m^2)
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Body Mass Index
|
Baseline to 9 months and sustained at 15 months
|
Waist Circumference
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Waist Circumference
|
Baseline to 9 months and sustained at 15 months
|
Fasting Glucose
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Fasting Glucose
|
Baseline to 9 months and sustained at 15 months
|
Hemoglobin A1c or HbA1c
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Hemoglobin A1c or HbA1c
|
Baseline to 9 months and sustained at 15 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Diet/Nutrition - Plasma Carotenoid Levels
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Plasma Carotenoid levels reflect changing dietary vegetable and fruit intake.Nutrition Data Systems for REsearch (NDS-R) Protocol
|
Baseline to 9 months and sustained at 15 months
|
Diet/Nutrition - Serum Lipid Levels
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Plasma Carotenoid levels reflect changing dietary vegetable and fruit intake.
|
Baseline to 9 months and sustained at 15 months
|
Objective Measure of Physical Activity
Tidsramme: Baseline to 9 months and sustained at 15 months
|
For 7 days during each assessment period, participants will wear the GT3X+ Actigraph, which measures movement and intensity of activity, and has good validation with VO2max.
It provides estimates of activity by seconds, that can be categorized into minutes spent in sedentary, light, moderate, and vigorous activity using calibration thresholds.
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Baseline to 9 months and sustained at 15 months
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Smoking - Expired Breath Carbon Monoxide (CO) Levels
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Smoking - Objective Measure of Cigarette Use: Expired Breath Carbon Monoxide (CO) level (parts per million) is measured with a handheld device.
CO monitoring is used primarily as a check on recent smoking, though it has also been used to indicate reductions in smoking.
|
Baseline to 9 months and sustained at 15 months
|
Smoking - Change in Smoking through Recall
Tidsramme: Baseline to 9 months and sustained at 15 months
|
Change in Smoking - Quantity and frequency of cigarette use for the prior week using a timeline followback procedure.
Smoking reduction calculated by % change in average cigarettes/day across assessments.
|
Baseline to 9 months and sustained at 15 months
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MH15127
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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