Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

30. November 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

83

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • University of Kansas Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

13 Jahre bis 30 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group One
Intervention
Verhalten: 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.
Aktiver Komparator: Group Two
Control
Verhalten: iPad use plus one mobile connections to multidisciplinary professionals & peers
iPad with a data plan and one professionally moderated iPad visual meeting with peers.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Health Survey SF-12v2 (predicts future health services use).
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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).
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Preparedness (measures skills needed for independent HPN home care).
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Kansas Medical Center

Mitarbeiter

National Institute of Nursing Research (NINR)

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2016

Primärer Abschluss (Tatsächlich)

1. Dezember 2019

Studienabschluss (Tatsächlich)

1. Juni 2020

Studienanmeldedaten

Zuerst eingereicht

6. Dezember 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Dezember 2016

Zuerst gepostet (Schätzen)

9. Dezember 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Dezember 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. November 2020

Zuletzt verifiziert

1. November 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00004067
  • R01NR015743-01A1 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren