Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers
30 de noviembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
83
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
13 años a 30 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group One
Intervention
|
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.
|
|
Comparador activo: Group Two
Control
|
iPad with a data plan and one professionally moderated iPad visual meeting with peers.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health Survey SF-12v2 (predicts future health services use).
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preparedness (measures skills needed for independent HPN home care).
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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).
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carol E Smith, RN, PhD, FAAN, University of Kansas Medical Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2016
Finalización primaria (Actual)
1 de diciembre de 2019
Finalización del estudio (Actual)
1 de junio de 2020
Fechas de registro del estudio
Enviado por primera vez
6 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
8 de diciembre de 2016
Publicado por primera vez (Estimar)
9 de diciembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de diciembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00004067
- R01NR015743-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
All data is de-identified and will be reported only in aggregate.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .