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Optimizing Self-Management Adherence and Glycemic Control in Older Teens With Type 1 Diabetes: The Teenwork Study

3. august 2021 opdateret af: Lori Laffel, Joslin Diabetes Center
The purpose of this 18-month randomized controlled trial (RCT) is to find out if (1) a set of psychoeducational materials for teens with type 1 diabetes and (2) text message reminders to check blood glucose levels can help improve blood glucose levels in teens with type 1 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Glycemic control deteriorates during adolescence as parents become less involved in teens' diabetes management and adherence declines. Thus, there is a need to improve adherence and glycemic control in mid to older teens with type 1 diabetes by strengthening the teens' self-efficacy for daily diabetes self-management to help prepare them for the transition between pediatric and adult care. This 18-month, multi-center RCT is designed to increase frequency of blood glucose monitoring and improve glycemic control in teens with type 1 diabetes through a behavioral intervention called Teenwork with or without text message reminders to check blood glucose levels.

We will implement and evaluate the Teenwork intervention and text message reminders to check blood glucose levels in a 2x2 factorial design in which 300 participants, across two sites, will be randomized to 1 of 4 groups: Teenwork, Text Message, Teenwork/Text Message, or Usual Care.

Participants in the Teenwork Group will meet with a research assistant during each study visit to review strategies for improving self-care, including self-management and self-advocacy, focusing on two areas: blood glucose monitoring and insulin administration. Participants in the Text Message Group will be instructed in the use of the text messaging system. They will receive 2-way text message reminders to check blood glucose levels at self-selected times and to reply by text message with blood glucose results. Participants in the Teenwork/Text Message Group will receive both the Teenwork intervention and the text message reminders (as described above). Participants in the Usual Care Group will receive the same intervention as the Teenwork/Text Message Group, but not until after 1 year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

310

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Joslin Diabetes Center
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Texas Children's Hospital/Baylor College of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Youth age 13-17 years
  • Diagnosis of type 1 diabetes according to American Diabetes Association criteria
  • Diabetes duration ≥6 months
  • Daily insulin dose ≥0.5 units/kg
  • A1c ≥6.5%and ≤11%
  • Willingness to check blood glucose levels
  • Cell phone with text messaging ability

  • Clinic attendance

    1. At least one clinic visit at the clinical site in the previous 12 months
    2. Anticipated care at the clinical site for the duration of the study
  • Fluency in English (reading, writing, and speaking) for child and parent/guardian
  • Enrollment no later than December of the teen's senior year of high school

Exclusion Criteria:

  • Pregnancy in the youth participant
  • Significant developmental or cognitive disorder that would prevent full study participation
  • Significant mental illness, defined by either major psychiatric disorder (e.g., diagnosed eating disorder, major psychoses) or inpatient psychiatric admission within the previous 6 months
  • Failure to understand that the 2-way text messaging does NOT result in immediate response from a health care professional; this will be assessed at the time of informed consent/assent
  • Participation in another intervention study within the 3 months prior to enrollment
  • Other psychosocial, medical, or family issues, as assessed by the teen's pediatric team, that would prevent full study participation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Teenwork Group
Teen/family will receive the Teenwork intervention at each quarterly study visit.
Adfærdsmæssigt: Teenwork intervention
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Eksperimentel: Teenwork/Text Message Group
Teen/family will receive the Teenwork intervention at each quarterly study visit. Teen will receive text message reminders to check blood glucose levels at self-selected times.
Adfærdsmæssigt: Teenwork intervention
Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
Adfærdsmæssigt: Text message reminders
Text message reminders to check blood glucose levels at self-selected times
Eksperimentel: Text Message Group
Teen will receive text message reminders to check blood glucose levels at self-selected times.
Adfærdsmæssigt: Text message reminders
Text message reminders to check blood glucose levels at self-selected times
Ingen indgriben: Usual Care Group
Teen/family will receive routine clinical care for the first year of the study (the time period for assessment of primary outcomes). After year 1, teen/family will receive the Teenwork intervention at each remaining study visit and teen will receive text message reminders to check blood glucose levels at self-selected times.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in glycemic control from baseline to 1 year
Tidsramme: Baseline and 1 year
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
Baseline and 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in glycemic control from 1 year to 18 months
Tidsramme: 1 year and 18 months
Glycemic control will be assessed as A1c (DCCT-standardized assay, ref range 4.0-6.0%)
1 year and 18 months
Psychosocial factors (self-report surveys)
Tidsramme: Baseline, 6 months, 1 year, 18 months
We will assess psychosocial factors (e.g., diabetes-specific family conflict, diabetes burden, negative affect around blood glucose monitoring, quality of life, depressive symptoms, self-efficacy, disordered eating behaviors) every 6 months
Baseline, 6 months, 1 year, 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Joslin Diabetes Center

Samarbejdspartnere

Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Barbara J. Anderson, PhD, Texas Children's Hospital/Baylor College of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

1. juli 2013

Først indsendt, der opfyldte QC-kriterier

1. juli 2013

Først opslået (Skøn)

4. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012-11
  • R01DK095273 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med Teenwork intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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