Family Health Partners in Regional Network Structures (NEST)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Disabled or Chronically Ill Children in Need of Care
• Intervention / Treatment: Other: Families with FGP support

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).

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lüdecke, PhD; Phone Number: +49 40 7410-54934; Email: d.luedecke@uke.de
• Study Contact Backup: Name: Isabella Helmreich, PhD; Phone Number: +49 6131 89448-11; Email: isabella.helmreich@lir.de

Study Locations

• Germany
  • Mainaschaff, Germany, D-63814
    • Kindernetzwerk e.V.
  • Trier, Germany, D-54290
    • Nestwärme gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Families with FGP support; Non-randomized controlled trial with four points of measurement ( in 18 months)
No Intervention: Control Group (CG); Families without FGP support (standard care) under the same conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family quality of life	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.	18 months
Parents' mental and physical health	General Health Questionnaire-28 - GHQ-28	18 months
Well-being	WHO-Five Well-being Index - WHO-5	18 months
Stress experience	Perceived Stress Scale - PSS-4	18 months
Family burden due to illness of the child	Impact-on-Family Scale - IOFS-20	18 months
Family cohesion	Resilience Scale for Adults - RSA	18 months
Resilience	Brief Resilience Scale - BRS	18 months
Individual stressor exposure	Mainz Inventory of Microstressors - MIMIS	18 months
Life events	Life History Calendar - LHC	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience factors and associated measures	Name of the measurement and measurement tools can be seen below (outcome measures 11-14). Unit of measure are both measures of central tendency and measures of variability.	18 months
Optimism / positive thinking	Scale Optimism-Pessimism-2 - SOP-2	18 months
Locus of control	Internal and External Locus of Control Scale-4 - IE-4	18 months
Self-efficacy	General Self-efficacy Short Scale - ASKU-3	18 months
Social support	Oslo Social Support Scale - OSSS-3	18 months
Access to care	Operationalization see below (outcome measures 16-18).	18 months
Satisfaction with health care	Self-developed questionnaire with 13 items	18 months
Use of support services	Self-developed questionnaire with 21 items	18 months
Satisfaction with health coordination	Case Management questionnaire with 11 items	12 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Federal Joint Committee; aQua-Institut GmbH, Germany; Leibniz-Institut für Resilienzforschung, Germany; nestwärme gGmbH, Germany; Kindernetzwerk e.V., Germany; ism gGmbH, Germany
• Investigators: Study Director: Gerald Willms, PhD, aQua-Institut GmbH, Germany

Publications and helpful links

Helpful Links

• Research project N.E.S.T.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: family caregivers; children in need of care; Family Health Partner; non-medical care; regional networking
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 01VSF20004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No