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Transition Preparation Intervention for Young Adults With Type 1 Diabetes

5. november 2020 oppdatert av: Virginia Commonwealth University

Implementing a Transition Preparation Intervention for Young Adults With Type 1 Diabetes in an Integrated Healthcare Setting

The purpose of this research study is to find out more about how to support young adults (ages 18-22) with type 1 diabetes as they prepare to transition from pediatric and adult endocrinology medical care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The overarching goal of the proposed trial is to improve diabetes self-management and glycemic control in young adults and prepare them for the transition to adult endocrinology. The current application will investigate the impact of a multisystem transition preparation intervention for young adults (ages 18-22) with T1D. Twenty-five young adults and a parent will be enrolled in a 6-month transition preparation program which will use a hybrid in-person and technology delivery structure. Providers will receive training highlighting their role preparing young adults for transition and provides practical tips to use in their communication with young adults. If effective, this multisystem intervention, designed to enhance T1D self-management and increase young adults' readiness for transition to adult healthcare during this critical developmental period, has the potential to inform clinical practice guidelines.

Studietype

Intervensjonell

Registrering (Faktiske)

62

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Virginia
      • Richmond, Virginia, Forente stater, 23298
        • Children's Hospital of Richmond at Virginia Commonwealth University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Both members of the youth/parent dyad must meet all eligibility criteria

Young adults

  • English-speaking
  • patients in Pediatric Endocrinology at Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU)
  • between ages 18-22 yrs with a
  • diagnosis of T1D for >1 year

Parents

  • greater than 18 years of age
  • provide care to the young adult with T1D
  • are willing to participate in the intervention

Medical providers

• provide care to patients with T1D ages 18-22 yrs in Pediatric Endocrinology at CHoR

Exclusion Criteria:

Young adults

  • significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability), as documented in the medical record or revealed during eligibility screening, or
  • medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes

Parents

  • non-English speaking
  • psychiatric, cognitive, or developmental conditions that would impair their ability to complete assessments and/or engage in the intervention as determined at study screening

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Transition preparation program
Transition preparation intervention for young adults with type 1 diabetes (T1D)
Atferdsmessig: Transition preparation intervention
Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of sessions attended
Tidsramme: 6 months
Number of study visits (attendance)
6 months
Number of session views
Tidsramme: 6 months
Number of opened electronic materials (e.g., opened messages in the patient health portal))
6 months
Program acceptability - young adult
Tidsramme: 9 months
Young adult report on satisfaction with the program via an exit survey
9 months
Program acceptability - parent
Tidsramme: 9 months
Parent report on satisfaction with the program via an exit survey
9 months
Program acceptability - provider
Tidsramme: 9 months
Provider report on satisfaction with the program via an exit survey
9 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Glycemic control
Tidsramme: Baseline to 9 months
Measurement of hemoglobin A1c (A1c; reported as a percentage)
Baseline to 9 months
Diabetes-related hospitalizations
Tidsramme: 9 months
Participant report and medical record review of count of reported diabetes-related hospitalizations and complications
9 months
Change in adherence to diabetes care regimen
Tidsramme: Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Management Questionnaire (DMQ)
Baseline to 9 months
Change in transition readiness
Tidsramme: Baseline to 9 months
Average of young adult and parent participant reports on the Transition Readiness Assessment Questionnaire (TRAQ)
Baseline to 9 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in diabetes self-efficacy
Tidsramme: Baseline to 9 months
Participant (young adult) report on the Self-Efficacy for Diabetes Self-Management (SEDSM)
Baseline to 9 months
Change in diabetes quality of life
Tidsramme: Baseline to 9 months
Participant (young adult) report on the Pediatric Quality of Life Diabetes Module
Baseline to 9 months
Change in diabetes family responsibility
Tidsramme: Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Family Responsibility Questionnaire (DFRQ)
Baseline to 9 months
Change in diabetes family conflict
Tidsramme: Baseline to 9 months
Average of young adult and parent participant reports on the Diabetes Family Conflict Scale (DFCS)
Baseline to 9 months
Change in depression
Tidsramme: Baseline to 9 months
Participant (young adult) report on the Center for Epidemiologic Studies Depression Scale (CESD)
Baseline to 9 months
Change in young adult diabetes distress
Tidsramme: Baseline to 9 months
Participant (young adult) report on the Diabetes Distress Scale
Baseline to 9 months
Change in parent diabetes distress
Tidsramme: Baseline to 9 months
Participant (parent) report on the Diabetes Distress Scale for Parents of Teens with T1D
Baseline to 9 months
Change in autonomy support
Tidsramme: Baseline to 9 months
Participant (young adult) report on the autonomy support sub-scale of the Barriers to Diabetes Adherence Questionnaire
Baseline to 9 months
Change in problem solving
Tidsramme: Baseline to 9 months
Participant (young adult) report on the Diabetes Adherence Problem Solving Questionnaire
Baseline to 9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Virginia Commonwealth University

Samarbeidspartnere

American Diabetes Association

Etterforskere

  • Hovedetterforsker: Laura Caccavale, PhD, Virginia Commonwealth University
  • Hovedetterforsker: Melanie Melanie, PhD, Virginia Commonwealth University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. juli 2019

Primær fullføring (Faktiske)

16. september 2020

Studiet fullført (Faktiske)

16. september 2020

Datoer for studieregistrering

Først innsendt

24. juni 2019

Først innsendt som oppfylte QC-kriteriene

24. juni 2019

Først lagt ut (Faktiske)

26. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HM20015399
  • 1-19-PDF-041-R (Annet stipend/finansieringsnummer: American Diabetes Association)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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