- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03241212
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
Adolescent Self-Care and Knowledge Education in Diabetes--Improved by Texting (ASKED-IT)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Colorado
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Aurora, Colorado, Forenede Stater, 800045
- Barbara Davis Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of type 1 diabetes mellitus
- Receiving care in the pediatric clinic at the Barbara Davis Center (BDC)
- Age 15-20 at study enrollment
- English literate and English speaking
- Ability to complete the required surveys
- Have a personal cell phone with service compatible with EZTexting Platform
- Able to provide informed assent or consent (if 18 years of age or older) and parental informed consent (if needed).
Exclusion Criteria:
- Not planning to continue care in the pediatric clinic at BDC for at least the next 6 months.
- Diabetes Diagnosis other than Type 1 Diabetes
- Inability for the adolescent to respond to text messages (e.g. due to developmental delay)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control
At baseline enrollment: participants will be asked to fill out a demographic survey, the MWIKAD survey and the SMOD-A survey. HbA1c, frequency of Blood Glucose (BG) checks and percent of glucose values above, within and below the target range will be extracted from chart review. Surveys (with the exception of demographics) and chart extraction will be repeated at 3 months and 6 months post enrollment. |
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Eksperimentel: Texting
Participants will be asked to complete the same surveys on the same timeline as above. The texting group will be asked to provide their cell phone number to the texting software. From baseline appointment to 26 weeks post enrollment, participants will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen. |
From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday.
Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in knowledge about type 1 diabetes
Tidsramme: 6 months from intervention
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Measured by the Mercy-What I Know About Diabetes Test (MWIKAD)
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6 months from intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in diabetes self-care practices
Tidsramme: at 3 months and 6 months
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Assessed by the Self-Management of Type 1 Diabetes in Adolescents (SMOD-A) tool
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at 3 months and 6 months
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Change in Hemoglobin A1c
Tidsramme: at 3 months and 6 months
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at 3 months and 6 months
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Change in blood glucose testing frequency
Tidsramme: at 3 months and 6 months
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at 3 months and 6 months
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Change in percent of blood glucoses high, in range and low
Tidsramme: at 3 months and 6 months
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at 3 months and 6 months
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Percent of text messages responded to in the study.
Tidsramme: After 6 months of texting intervention
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After 6 months of texting intervention
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Sonalee Ravi, MD, University of Colorado, Denver
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 17-1135
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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