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Clinical Trials/NCT05418205
NCT05418205
Active, not recruiting
Not Applicable

Strengthening and Relieving the Burden on Families With Children in Need of Care Through Family Health Partners [Familien-Gesundheits-Partner; FGP] in Regional Network Structures

Universitätsklinikum Hamburg-Eppendorf2 sites in 1 country204 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disabled or Chronically Ill Children in Need of Care
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
204
Locations
2
Primary Endpoint
Resilience
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Families with children with severe health problems are exposed to particular emotional, social, economic and time burdens. These result in further risks, which often lead to poor living and care situations for the families concerned. This is attributed, among other, to legal regulations that do not do justice to the respective individual life situations and the lack of competent information and counselling services. The overarching objective of the NEST project is to evaluate the effectiveness of a professional support facility for families with children in need of care that operates across sectors and service providers. The network support by so-called Family Health Partners [Familien-Gesundheits-Partner; FGP] aims to provide assistance and need-based individual care for all members in families with children in need of care. The medium-term goal of FGP support is to develop the family as a self-help system, i.e. as a self-competent, independently acting primary resource for the care and support of their children in need of care.

Detailed Description

The project starts facing the problem that families with children with severe health problems are exposed to strong emotional, social, economic and temporal burdens. This results in further health, social and economic risks, which often lead to poor living and care situations for the families concerned. This is attributed, among other things, to legal regulations that do not do justice to the respective individual life situations and the lack of competent advice and contact points. The overarching objective of the NEST project is the evaluation of an innovative support service that addresses the problem. The network support by so-called Family Health Partners \[Familien-Gesundheits-Partner; FGP\] aims to provide needs-based, individual care for all members in families with children in need of care, i.e. the best possible physical, psychological and participation-oriented care for children in need of care, thus relieving the relatives who spend much time for care and assistance of their child/children. The intervention to be evaluated here with regard to its effectiveness and to be analyzed with regard to its impact factors (processes and structures) was summarized in the term of FGP. This personalized function, which is anchored in the network, aims to provide "holistic" support for families with children in need of care. This means that the needs of the families are determined individually and initially independent of sectoral or service provider specific offers (structured assessment). The needs of families not only relate to medical, nursing or therapeutic care, but also to assistance regarding social law, economic and bureaucratic advice as well as social, psychosocial and emotional needs and social participation. Based on the identified need for support, affected families are individually accompanied by FGP over a certain period of time (in the project context: a maximum of 18 months). The medium-term goal of FGP support is to strengthen or maintain the family as a self-help system, i.e. self-efficient, independently acting primary resource for the care and support of their children (preventive).

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
September 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • parents and other guardians with at least one disabled and/or chronically ill child under 18 years in western and southern Germany
  • all genders and ethnicities will be included in the study

Exclusion Criteria

  • caregivers for children in need of care according to § 37 of Germany's Social Security Code V level of care = 1 (i.e. minor impairments of independence or abilities)

Outcomes

Primary Outcomes

Resilience

Time Frame: 18 months

Brief Resilience Scale - BRS

Family quality of life

Time Frame: 18 months

Name of the measurement and measurement tools can be seen below (outcome measures 2-9). Unit of measure are both measures of central tendency and measures of variability.

Well-being

Time Frame: 18 months

WHO-Five Well-being Index - WHO-5

Parents' mental and physical health

Time Frame: 18 months

General Health Questionnaire-28 - GHQ-28

Stress experience

Time Frame: 18 months

Perceived Stress Scale - PSS-4

Family burden due to illness of the child

Time Frame: 18 months

Impact-on-Family Scale - IOFS-20

Life events

Time Frame: 18 months

Life History Calendar - LHC

Family cohesion

Time Frame: 18 months

Resilience Scale for Adults - RSA

Individual stressor exposure

Time Frame: 18 months

Mainz Inventory of Microstressors - MIMIS

Secondary Outcomes

  • Resilience factors and associated measures(18 months)
  • Optimism / positive thinking(18 months)
  • Social support(18 months)
  • Access to care(18 months)
  • Satisfaction with health care(18 months)
  • Self-efficacy(18 months)
  • Use of support services(18 months)
  • Locus of control(18 months)
  • Satisfaction with health coordination(12 months)

Study Sites (2)

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