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Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes

19. července 2022 aktualizováno: University of Colorado, Denver
This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

AIM 1: PHASE 1: Use Multiphasic Optimization Strategy (i.e., MOST), a highly efficient experimental strategy, to determine specific components for inclusion in an intervention to 1a) improve primary clinical outcomes of A1C and percentage of time spent in hyperglycemia and 1b) address secondary clinical outcomes by improving adherence and biological markers of complications in high-risk pediatric patients with T1D (A1C=9-12%) as part of 12-month personalized behavioral intervention delivered via in-person T1D clinic visits and home telemedicine.

MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., Randomized Controlled Trials (RCT)) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power.

H1: There will be a main effect of Personalized Adherence Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.

H2: There will be a main effect of Personalized Behavioral Health Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.

AIM 2: PHASE 2: Determine effectiveness of the intervention components on maintenance of A1C, percentage of time spent in hyperglycemia, adherence, and biological markers improvements throughout 6-month follow-up.

H1: Participants who are randomized to T1D medical appointments every 6 weeks will show better improvements in gains in A1C, percentage of time spent in hyperglycemia, adherence, and biological markers compared to those participants who revert to medical appointments occurring every 3 months.

Typ studie

Intervenční

Zápis (Aktuální)

108

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Colorado
      • Aurora, Colorado, Spojené státy, 80045
        • Barbara Davis Center for Childhood Diabetes

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

10 let až 17 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • youth age 10-17 years
  • A1C=9-12%
  • parent(s) of child with confirmed diagnosis of T1D
  • T1D duration >1 year
  • parent and child agree to participate in home telehealth sessions
  • ability to use telehealth equipment (i.e., computer, tablet, smartphone with internet connectivity)

Exclusion Criteria:

  • developmental disability or reading disorder that prevents understanding of the intervention materials
  • non-English speaking adolescents
  • those with severe psychological disorders
  • prescribed and taking medications that increase blood glucoses
  • not seen in T1D clinic within the past year; pregnant if female; situational concerns (e.g., active custody battle)
  • type 2 diabetes

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Home Telehealth T1D (CoYoT1-HR)
Home Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth
Behaviorální: Home Telehealth T1D C2oYoT1-HR
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR
Experimentální: Personalized Adherence Feedback
C2oYoT1-HR+Personalized Adherence Intervention
Behaviorální: Personalized Adherence Feedback
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR + Personalized Adherence Intervention
Experimentální: Personalized Behavioral Health
C2oYoT1-HR+Personalized Behavioral Health
Behaviorální: Personalized Behavioral Health
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR + Behavioral Health
Experimentální: C2oYoT1-HR + Adherence + Behavioral
C2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral)
Behaviorální: Home Telehealth T1D C2oYoT1-HR
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR
Behaviorální: Personalized Adherence Feedback
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR + Personalized Adherence Intervention
Behaviorální: Personalized Behavioral Health
1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Ostatní jména:
  • C2oYoT1-HR + Behavioral Health

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 12, 24, 36, 48, 72
A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits. In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36). The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care. Change in A1c will be looked at from baseline every 3 months throughout the study.
weeks 1, 12, 24, 36, 48, 72
Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 12, 24, 36, 48, 72
Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.
weeks 1, 12, 24, 36, 48, 72
Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 12, 24, 36, 48, 72
The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.
weeks 1, 12, 24, 36, 48, 72

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 12, 24, 36, 48, 72
Objectively Measured Adherence, Self-Reported Adherence, Number of T1D Appointments Attended. - change will be looked at from baseline every 3 months throughout the study.
weeks 1, 12, 24, 36, 48, 72
Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 24, 48, 72
Diabetes Family Conflict Scale (DFCS), Diabetes Family Responsibility Questionnaire (DFRQ), Hypoglycemia Fear Scale (HFS), Patient Health Questionnaire - 9 (PHQ-9), Problem Area in Diabetes Version (PAID), Puberty - change will be looked at from baseline every 3 months throughout the study.
weeks 1, 24, 48, 72
Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Časové okno: weeks 1, 24, 48, 72
Urinary microalbumin, endothelial function - change will be looked at from baseline every 3 months throughout the study.
weeks 1, 24, 48, 72

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Colorado, Denver

Spolupracovníci

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kimberly A Driscoll, PhD, University of Colorado, Denver

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. listopadu 2017

Primární dokončení (Aktuální)

30. září 2021

Dokončení studie (Aktuální)

30. září 2021

Termíny zápisu do studia

První předloženo

21. srpna 2017

První předloženo, které splnilo kritéria kontroly kvality

24. října 2017

První zveřejněno (Aktuální)

27. října 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. července 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. července 2022

Naposledy ověřeno

1. července 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 17-0004 (Jiný identifikátor: DMID)
  • DP3DK113363 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

no sharing will occur at this point.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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