Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers

30 november 2020 bijgewerkt door: University of Kansas Medical Center

Teen Connections for Support From Multidisciplinary Professionals & Peers

12 month study testing mobile delivery of health information and connections to professionals and peers to improve health of teen/young adult HPN users.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This research study will test the effect of in-home/mobile HPN support delivered to teen and young adult home parenteral nutrition (HPN) patients and family members over handheld personal computers. Effects on health status, QoL, and fatigue will be assessed over time between groups of study subjects from the ages of 13 through 30 randomized to one of two groups. Group One (intervention group) will receive mConnect, integrated evidence-based interventions (skill-building games, restorative naps & peer support) via mobile iPad and Internet delivery plus two real-time audiovisual encrypted connections with multidisciplinary professionals and peers. Group Two (control group) will receive healthy activity information via mobile iPad and Internet delivery plus one real-time audiovisual encrypted connection with professionals and peers.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

83

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 30 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Total parenteral nutrition (TPN) patients/users and family members/caregivers (defined as those individuals involved in daily home HPN care) age 13 and older
  • TPN users (also called HPN users) ages 13 through 30 must be receiving intravenous nutrition for a non-malignant short bowel disorder
  • Read, write, speak English and provide informed consent
  • Be able to participate in group clinic visits

Exclusion Criteria:

  • Enteral nutrition dependency only
  • Less than 13 years of age
  • 13 through 17 years of age without parental consent
  • Currently enrolled in an intervention study or HPN management program
  • Severe cognitive impairment
  • Disability disorders (e.g. blindness which cannot be accommodated for active participation in the group clinics

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group One
Intervention
Gedragsmatig: mConnect plus mobile connections to multidisciplinary professionals & peers
mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.
Actieve vergelijker: Group Two
Control
Gedragsmatig: iPad use plus one mobile connections to multidisciplinary professionals & peers
iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Health Survey SF-12v2 (predicts future health services use).
Tijdsspanne: T0 (baseline data collection)
Physical and mental health status from each person's perspective. 7-Item Likert
T0 (baseline data collection)
Quality of Life (Cantril Ladder)
Tijdsspanne: T0 (baseline data collection)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
T0 (baseline data collection)
Beck Depression Inventory-II (BDI-II)
Tijdsspanne: T0 (baseline data collection)
Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
T0 (baseline data collection)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Tijdsspanne: T2 (month 1-2/mConnect intervention period)
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
T2 (month 1-2/mConnect intervention period)
Use of Healthy Living Activities Prompts, health intentions that predict engagement in targeted activities.
Tijdsspanne: T3 (month 3-4/mConnect intervention period)
Intention scale for healthy activities use (iPad discussion sessions, website use including games; mConnect use) 10-Item Likert
T3 (month 3-4/mConnect intervention period)
Beck Depression Inventory-II (BDI-II)
Tijdsspanne: T3 (4 months: change from T0/baseline)
Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).
Tijdsspanne: T3 (4 months: change from T0/baseline)
Physical and mental health status from each person's perspective. 7-Item Likert
T3 (4 months: change from T0/baseline)
Quality of Life (Cantril Ladder)
Tijdsspanne: T3 (4 months: change from T0/baseline)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
T3 (4 months: change from T0/baseline)
Health Survey SF-12v2 (predicts future health services use).
Tijdsspanne: T4 (8 months: change from T3/4 months)
Physical and mental health status from each person's perspective. 7-Item Likert
T4 (8 months: change from T3/4 months)
Quality of Life (Cantril Ladder)
Tijdsspanne: T4 (8 months: change from T3/4 months)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
T4 (8 months: change from T3/4 months)
Beck Depression Inventory-II (BDI-II)
Tijdsspanne: T4 (8 months: change from T3/4 months)
Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
T4 (8 months: change from T3/4 months)
Health Survey SF-12v2 (predicts future health services use).
Tijdsspanne: T5 (12 months: change from T4/8 months)
Physical and mental health status from each person's perspective. 7-Item Likert
T5 (12 months: change from T4/8 months)
Quality of Life (Cantril Ladder)
Tijdsspanne: T5 (12 months: change from T4/8 months)
Ratings of quality of life over time that are sensitive to changes in health. 3-Item Likert
T5 (12 months: change from T4/8 months)
Beck Depression Inventory-II (BDI-II)
Tijdsspanne: T5 (12 months: change from T4/8 months)
Assesses assess the intensity of depression into alignment with DSM-IV criteria. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. 21-Item
T5 (12 months: change from T4/8 months)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Preparedness (measures skills needed for independent HPN home care).
Tijdsspanne: T0 (baseline data collection)
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
T0 (baseline data collection)
COOPS Social Support Scale
Tijdsspanne: T0 (baseline data collection)
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
T0 (baseline data collection)
Preparedness (measures skills needed for independent HPN home care).
Tijdsspanne: T3 (4 months: change from T0/baseline)
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
T3 (4 months: change from T0/baseline)
COOPS Social Support Scale
Tijdsspanne: T3 (4 months: change from T0/baseline)
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
T3 (4 months: change from T0/baseline)
Mobile Care Helpfulness & Willingness-to-Pay Fees for Distance Health.
Tijdsspanne: T4 (8 months)
Rating of Helpfulness and willingness to pay for mobile care delivery. 10-Item Likert
T4 (8 months)
Preparedness (measures skills needed for independent HPN home care).
Tijdsspanne: T4 (8 months: change from T3/4 months)
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
T4 (8 months: change from T3/4 months)
COOPS Social Support Scale
Tijdsspanne: T4 (8 months: change from T3/4 months)
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
T4 (8 months: change from T3/4 months)
Preparedness (measures skills needed for independent HPN home care).
Tijdsspanne: T5 (12 months: change from T4/8 months)
Ability to manage home-care; low score = needs home care assistance. 8-Item Likert
T5 (12 months: change from T4/8 months)
COOPS Social Support Scale
Tijdsspanne: T5 (12 months: change from T4/8 months)
Ratings on having others who help, listen & provide tangible assistance support. 13-Item Likert
T5 (12 months: change from T4/8 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Kansas Medical Center

Medewerkers

National Institute of Nursing Research (NINR)

Onderzoekers

  • Hoofdonderzoeker: Carol E Smith, RN, PhD, FAAN, University of Kansas Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2016

Primaire voltooiing (Werkelijk)

1 december 2019

Studie voltooiing (Werkelijk)

1 juni 2020

Studieregistratiedata

Eerst ingediend

6 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

8 december 2016

Eerst geplaatst (Schatting)

9 december 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 december 2020

Laatste update ingediend die voldeed aan QC-criteria

30 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00004067
  • R01NR015743-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

All data is de-identified and will be reported only in aggregate.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren