Finding Immune Nascent Type 1 Diabetes (FIND T1D)
Finding Immune Nascent Type 1 Diabetes (FIND T1D)
The goal of this clinical trial is to understand how many individuals who previously participated in the Indiana Biobank will return a type 1 diabetes home screening kit based upon different methods of recruitment communication. The main question it aims to answer is:
What form of recruitment communication is most effective for completing a type 1diabetes home screening kit?
Researchers will compare two types of recruitment contact: email and mail based communication (low-touch) versus phone contact and follow-up by a research team member (high-touch).
Participants will be contacted either via email/mail or by phone and asked if they want to complete a type 1 diabetes home screening kit.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Maureen Mullen Montagano
- Telefonnummer: 317-274-7677
- E-post: findt1d@iu.edu
Studera Kontakt Backup
- Namn: Adarsh Viswanath
- Telefonnummer: 317-278-5033
- E-post: findt1d@iu.edu
Studieorter
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 46202
- Rekrytering
- Indiana University School of Medicine
-
Huvudutredare:
- Emily K Sims, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participant must be in Indiana Biobank
- Participant must be able to provide consent
- Ages 1-99 including pregnant women
Exclusion Criteria:
- Refusal to sign informed consent for home screening is exclusionary for the home screening portion of the study
- While other medical conditions are allowable prior diabetes diagnosis is exclusionary for home autoantibody screening
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Low-touch intervention
|
Recruitment through email and mail |
|
Experimentell: High-touch intervention
|
Recruitment through phone call |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rates of Returned Home Screening Kits
Tidsram: From enrollment to the end of study at 3 years.
|
The number of returned screening kits versus the number that were not returned by consented participants. |
From enrollment to the end of study at 3 years.
|
|
Rates of Consent
Tidsram: From enrollment to the end of study at 3 years.
|
The number of participants who consent versus the number of participants who do not consent. |
From enrollment to the end of study at 3 years.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent of Kits with Adequate Blood Volume
Tidsram: From enrollment to the end of study at 3 years.
|
From enrollment to the end of study at 3 years.
|
|
|
Rates of Returned Home Screening Kits
Tidsram: From enrollment to the end of study at 3 years
|
The number of returned screening kits versus the number that were not returned by consented participants. Some of which will receive information that they may be at increased risk of type 1 diabetes. |
From enrollment to the end of study at 3 years
|
|
Rates of Consent
Tidsram: From enrollment to the end of study at 3 years.
|
The number of participants who consent versus the number of participants who do not consent. Some participants will receive information that they may be at increased risk of type 1 diabetes. |
From enrollment to the end of study at 3 years.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 31119
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Participant results will be shared as summary data but because participants declining consent have not agreed we will not provide individual level data.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .