Family Health Partners in Regional Network Structures

NCT ID: NCT05418205

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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).

Conditions

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Disabled or Chronically Ill Children in Need of Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group (IG)

Families with FGP support (families with disabled and/or chronically children under 18 in the greater area of Mainz, Saarbrucken and Munich (Germany)

Group Type EXPERIMENTAL

Families with FGP support

Intervention Type OTHER

Non-randomized controlled trial with four points of measurement ( in 18 months)

Control Group (CG)

Families without FGP support (standard care) under the same conditions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Families with FGP support

Non-randomized controlled trial with four points of measurement ( in 18 months)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal Joint Committee

OTHER_GOV

Sponsor Role collaborator

aQua-Institut GmbH, Germany

UNKNOWN

Sponsor Role collaborator

Leibniz-Institut für Resilienzforschung, Germany

UNKNOWN

Sponsor Role collaborator

nestwärme gGmbH, Germany

UNKNOWN

Sponsor Role collaborator

Kindernetzwerk e.V., Germany

UNKNOWN

Sponsor Role collaborator

ism gGmbH, Germany

UNKNOWN

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerald Willms, PhD

Role: STUDY_DIRECTOR

aQua-Institut GmbH, Germany

Locations

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Kindernetzwerk e.V.

Mainaschaff, , Germany

Site Status

Nestwärme gGmbH

Trier, , Germany

Site Status

Countries

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Germany

References

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Broll J, Schafer SK, Ludecke D, Nickel S, Lieb K, Helmreich I. Effects of micro- and macro-stressors and resilience factors on the mental health of parents caring for chronically ill and disabled children and adolescents. BMC Nurs. 2025 May 2;24(1):489. doi: 10.1186/s12912-025-03125-6.

Reference Type DERIVED
PMID: 40316988 (View on PubMed)

Nickel S, Helmreich I, Broll J, Ludecke D. Family health partners in regional network structures (NEST): A non-randomized controlled trial among parents of chronically ill and disabled children. PLoS One. 2023 Jul 17;18(7):e0288435. doi: 10.1371/journal.pone.0288435. eCollection 2023.

Reference Type DERIVED
PMID: 37459306 (View on PubMed)

Related Links

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https://www.forschungsprojekt-nest.de

Research project N.E.S.T.

Other Identifiers

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01VSF20004

Identifier Type: -

Identifier Source: org_study_id

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