Clinical trial NCT05418205: Family Health Partners in Regional Network Structures
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Disabled or Chronically Ill Children in Need of Care
Keywords: children in need of care
family caregivers
Family Health Partner
non-medical care
regional networking
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Federal Joint Committee
name: aQua-Institut GmbH, Germany
name: Leibniz-Institut für Resilienzforschung, Germany
name: nestwärme gGmbH, Germany
name: Kindernetzwerk e.V., Germany
name: ism gGmbH, Germany
First posted: 2022-06-14
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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)

Primary outcomes:
measure: Family quality of life
timeFrame: 18 months
measure: Parents' mental and physical health
timeFrame: 18 months
measure: Well-being
timeFrame: 18 months
measure: Stress experience
timeFrame: 18 months
measure: Family burden due to illness of the child
timeFrame: 18 months
measure: Family cohesion
timeFrame: 18 months
measure: Resilience
timeFrame: 18 months
measure: Individual stressor exposure
timeFrame: 18 months
measure: Life events
timeFrame: 18 months
Secondary outcomes:
measure: Resilience factors and associated measures
timeFrame: 18 months
measure: Optimism / positive thinking
timeFrame: 18 months
measure: Locus of control
timeFrame: 18 months
measure: Self-efficacy
timeFrame: 18 months
measure: Social support
timeFrame: 18 months
measure: Access to care
timeFrame: 18 months
measure: Satisfaction with health care
timeFrame: 18 months
measure: Use of support services
timeFrame: 18 months
measure: Satisfaction with health coordination
timeFrame: 12 months
Other outcomes:
Locations:
city: Mainaschaff
country: Germany
facility: Kindernetzwerk e.V.
city: Trier
country: Germany
facility: Nestwärme gGmbH
Study officials:
affiliation: aQua-Institut GmbH, Germany
name: Gerald Willms, PhD
role: STUDY_DIRECTOR
References: