Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)
Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Detroit, Michigan, Verenigde Staten, 48201
- Children's Hospital of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Metabolic Control: Hemoglobin A1c (HbA1c)
Tijdsspanne: Change from Baseline at 7 months, Change from Baseline at 9 months
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retrospective measure of blood glucose control, encompasses the previous 2-3 months
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Change from Baseline at 7 months, Change from Baseline at 9 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Tijdsspanne: Change from Baseline at 7 months, Change from Baseline at 9 months
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The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
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Change from Baseline at 7 months, Change from Baseline at 9 months
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Quality of life
Tijdsspanne: Change from Baseline at 7 months, Change from Baseline at 9 months
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44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
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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
Tijdsspanne: Change from Baseline at 7 months, Change from Baseline at 9 months
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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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Deborah A Ellis, Ph.D, Wayne State University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R34DK102091-01 (Subsidie/contract van de Amerikaanse NIH)
- R34DK102091 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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