- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07581171
Creating Encounters Between Generations - Together Instead of Alone (GemsE) (GemsE)
Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The GemsE project - Creating Encounters: Generations in Action - Together Instead of Alone is an interventional study evaluating intergenerational mentoring between seniors and CYP from families with parents who have mental illness. The aim is to build stable, voluntary relationships that reduce loneliness and improve the mental well-being and health-related quality of life of both groups.
As part of the study, approximately 40 seniors and 40 children or adolescents will be accompanied in sponsorships over a period of six months. The impact of the sponsorships will be measured using standardized, validated questionnaires on loneliness, psychosocial well-being, and health-related quality of life. The results should provide insights into how intergenerational sponsorships can be effectively designed and integrated into psychosocial care services.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Silke Wiegand-Grefe, Prof. Dr.
- Número de teléfono: +4940741053603
- Correo electrónico: swiegand-grefe@uke.de
Copia de seguridad de contactos de estudio
- Nombre: Jana Wiehe
- Número de teléfono: +4940741024155
- Correo electrónico: j.wiehe@uke.de
Ubicaciones de estudio
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Hamburg, Alemania, 20246
- Reclutamiento
- University Medical Center Hamburg-Eppendorf
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Contacto:
- Silke Wiegand-Grefe, Prof. Dr.
- Número de teléfono: +4940741053603
- Correo electrónico: swiegand-grefe@uke.de
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Contacto:
- Jana Wiehe
- Número de teléfono: 49040741024155
- Correo electrónico: j.wiehe@uke.de
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Investigador principal:
- Silke Wiegand-Grefe, Prof. Dr.
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Sub-Investigador:
- Theresa Paumen
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Sub-Investigador:
- Jana Wiehe
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Older adults aged 60 years and older who are residents of Hamburg
- Children and adolescents aged 12 to 21 years with at least one parent with a mental illness and who are residents of Hamburg
- Sufficient German language proficiency
- Ability and willingness to provide informed consent to participate in the study
Exclusion Criteria:
- Children and adolescents with severe acute psychological symptoms requiring inpatient treatment, including acute suicidality, acute substance use, or acute psychotic symptoms
- Older adults with acute psychological crises or untreated severe mental illness preventing reliable participation
- Older adults with cognitive impairment or dementia preventing reliable participation in the intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Establishing intergenerational tandems
The intervention focuses on establishing stable mentoring relationships between senior citizens and children or adolescents from families with parents who have mental health issues. The main objectives of this intervention are to build reliable relationships, reduce loneliness, and promote mental well-being and quality of life for both groups. This intervention is coordinated by the project team at GemsE - Creating encounters: Generations in Action - Together Instead of Alone -. |
The project Creating Encounters Between Generations - Together Instead of Alone (German acronym GemsE) aims to provide social support and integration for both groups by establishing tandems between lonely senior citizens and COPMI, and to scientifically evaluate the effectiveness of these tandems.
The tandems run for six months, with weekly meetings between senior and CYP.
The tandems consist of weekly individual meetings with joint activities such as playing games, learning, cooking, or going for walks.
Senior citizens and CYP engage in tandems built on trust, shared experiences, and cooperation, fostering connections that benefit both sides at eye level.
Project coordinators accompany the participants and support the process management.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Loneliness
Periodo de tiempo: Change from baseline to 6 months.
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The primary clinically relevant parameter of the study is the experience of loneliness among children, adolescents, and seniors, measured using the 6-item short version of the De Jong Gierveld Loneliness Scale.The response options are three-point (yes, more or less, no) from 0-6 with higher scores indicating greater loneliness.
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Change from baseline to 6 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mental well-being
Periodo de tiempo: Change from baseline to 6 months.
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The mental well-being of seniors and young adults is assessed using the SDQ 18+, while the SDQ 11-17 is used for self-assessment for adolescents.
Scores range from 0 to 40, with higher scores indicating greater psychological difficulties and poorer mental well-being.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Adults
Periodo de tiempo: Change from baseline to 6 months.
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Health-related quality of life in participants aged 18 years and older will be assessed using the SF-12.
Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Children and Adolescents
Periodo de tiempo: Change from baseline to 6 months.
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Health-related quality of life in participants aged 12 to 17 years will be assessed using the KIDSCREEN-27 Questionnaire.
Scores range from 0 to 100, with higher scores indicating better quality of life.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Adults (EQ-5D-5L)
Periodo de tiempo: Change from baseline to 6 months
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Health-related quality of life in participants aged 18 years and older will be assessed using the EQ-5D-5L.
The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
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Change from baseline to 6 months
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Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Periodo de tiempo: Change from baseline to 6 months
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Health-related quality of life in participants from 12-17 years will be assessed using the EQ-5D-Y-5L.
The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
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Change from baseline to 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-101662-BO-ff
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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