- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02243072
Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.
The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Michigan
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- a current hemoglobin A1c(HbA1c) of >9.0%
- an average HbA1c of >9.0% during the past year
- reside in the metro Detroit tri-county area
- diagnosed with Type 1 diabetes for at least one year
- aged 10-17
- patient of Children's Hospital of Michigan Diabetes Clinic
Exclusion Criteria:
- severe mental impairment/thought disorder
- Active suicidality
- Active homicidality
- Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Fit Familes plus Standard Medical Care
Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.
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Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
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Ingen inngripen: Standard Medical Care
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Metabolic Control: Hemoglobin A1c (HbA1c)
Tidsramme: Change from Baseline at 7 months, Change from Baseline at 9 months
|
retrospective measure of blood glucose control, encompasses the previous 2-3 months
|
Change from Baseline at 7 months, Change from Baseline at 9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Tidsramme: Change from Baseline at 7 months, Change from Baseline at 9 months
|
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
|
Change from Baseline at 7 months, Change from Baseline at 9 months
|
Quality of life
Tidsramme: Change from Baseline at 7 months, Change from Baseline at 9 months
|
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
|
Change from Baseline at 7 months, Change from Baseline at 9 months
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Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Tidsramme: Change from Baseline at 7 months, Change from Baseline at 9 months
|
The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision.
Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
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Change from Baseline at 7 months, Change from Baseline at 9 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Deborah A Ellis, Ph.D, Wayne State University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R34DK102091-01 (U.S. NIH-stipend/kontrakt)
- R34DK102091 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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