NCT05418205

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

March 1, 2022

Last Update Submit

May 10, 2024

Conditions

Keywords

children in need of carefamily caregiversFamily Health Partnernon-medical careregional networking

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (9)

  • Resilience factors and associated measures

    18 months

  • Optimism / positive thinking

    18 months

  • Locus of control

    18 months

  • Self-efficacy

    18 months

  • Social support

    18 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

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

Control Group (CG)

NO INTERVENTION

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

Interventions

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

Intervention Group (IG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kindernetzwerk e.V.

Mainaschaff, D-63814, Germany

Location

Nestwärme gGmbH

Trier, D-54290, Germany

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

Study Officials

  • Gerald Willms, PhD

    aQua-Institut GmbH, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

June 14, 2022

Study Start

January 1, 2022

Primary Completion

April 30, 2024

Study Completion

September 30, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations