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Family Health Partners in Regional Network Structures (NEST)

Primary Purpose

Disabled or Chronically Ill Children in Need of Care

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Families with FGP support
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Disabled or Chronically Ill Children in Need of Care focused on measuring children in need of care, family caregivers, Family Health Partner, non-medical care, regional networking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Kindernetzwerk e.V.
  • Nestwärme gGmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group (IG)

Control Group (CG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Optimism / positive thinking
Scale Optimism-Pessimism-2 - SOP-2
Locus of control
Internal and External Locus of Control Scale-4 - IE-4
Self-efficacy
General Self-efficacy Short Scale - ASKU-3
Social support
Oslo Social Support Scale - OSSS-3
Access to care
Operationalization see below (outcome measures 16-18).
Satisfaction with health care
Self-developed questionnaire with 13 items
Use of support services
Self-developed questionnaire with 21 items
Satisfaction with health coordination
Case Management questionnaire with 11 items

Full Information

First Posted
March 1, 2022
Last Updated
February 20, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05418205
Brief Title
Family Health Partners in Regional Network Structures
Acronym
NEST
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group (IG)
Arm Type
Experimental
Arm Description
Families with FGP support (families with disabled and/or chronically children under 18 in the greater area of Mainz, Saarbrucken and Munich (Germany)
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
Families without FGP support (standard care) under the same conditions
Intervention Type
Other
Intervention Name(s)
Families with FGP support
Intervention Description
Non-randomized controlled trial with four points of measurement ( in 18 months)
Primary Outcome Measure Information:
Title
Family quality of life
Description
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.
Time Frame
18 months
Title
Parents' mental and physical health
Description
General Health Questionnaire-28 - GHQ-28
Time Frame
18 months
Title
Well-being
Description
WHO-Five Well-being Index - WHO-5
Time Frame
18 months
Title
Stress experience
Description
Perceived Stress Scale - PSS-4
Time Frame
18 months
Title
Family burden due to illness of the child
Description
Impact-on-Family Scale - IOFS-20
Time Frame
18 months
Title
Family cohesion
Description
Resilience Scale for Adults - RSA
Time Frame
18 months
Title
Resilience
Description
Brief Resilience Scale - BRS
Time Frame
18 months
Title
Individual stressor exposure
Description
Mainz Inventory of Microstressors - MIMIS
Time Frame
18 months
Title
Life events
Description
Life History Calendar - LHC
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Resilience factors and associated measures
Description
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.
Time Frame
18 months
Title
Optimism / positive thinking
Description
Scale Optimism-Pessimism-2 - SOP-2
Time Frame
18 months
Title
Locus of control
Description
Internal and External Locus of Control Scale-4 - IE-4
Time Frame
18 months
Title
Self-efficacy
Description
General Self-efficacy Short Scale - ASKU-3
Time Frame
18 months
Title
Social support
Description
Oslo Social Support Scale - OSSS-3
Time Frame
18 months
Title
Access to care
Description
Operationalization see below (outcome measures 16-18).
Time Frame
18 months
Title
Satisfaction with health care
Description
Self-developed questionnaire with 13 items
Time Frame
18 months
Title
Use of support services
Description
Self-developed questionnaire with 21 items
Time Frame
18 months
Title
Satisfaction with health coordination
Description
Case Management questionnaire with 11 items
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Willms, PhD
Organizational Affiliation
aQua-Institut GmbH, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Kindernetzwerk e.V.
City
Mainaschaff
ZIP/Postal Code
D-63814
Country
Germany
Facility Name
Nestwärme gGmbH
City
Trier
ZIP/Postal Code
D-54290
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.forschungsprojekt-nest.de
Description
Research project N.E.S.T.

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Family Health Partners in Regional Network Structures

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