Family Health Partners in Regional Network Structures (NEST)

May 10, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel Lüdecke, PhD
  • Phone Number: +49 40 7410-54934
  • Email: d.luedecke@uke.de

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family quality of life
Time Frame: 18 months
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
Time Frame: 18 months
General Health Questionnaire-28 - GHQ-28
18 months
Well-being
Time Frame: 18 months
WHO-Five Well-being Index - WHO-5
18 months
Stress experience
Time Frame: 18 months
Perceived Stress Scale - PSS-4
18 months
Family burden due to illness of the child
Time Frame: 18 months
Impact-on-Family Scale - IOFS-20
18 months
Family cohesion
Time Frame: 18 months
Resilience Scale for Adults - RSA
18 months
Resilience
Time Frame: 18 months
Brief Resilience Scale - BRS
18 months
Individual stressor exposure
Time Frame: 18 months
Mainz Inventory of Microstressors - MIMIS
18 months
Life events
Time Frame: 18 months
Life History Calendar - LHC
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resilience factors and associated measures
Time Frame: 18 months
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
Time Frame: 18 months
Scale Optimism-Pessimism-2 - SOP-2
18 months
Locus of control
Time Frame: 18 months
Internal and External Locus of Control Scale-4 - IE-4
18 months
Self-efficacy
Time Frame: 18 months
General Self-efficacy Short Scale - ASKU-3
18 months
Social support
Time Frame: 18 months
Oslo Social Support Scale - OSSS-3
18 months
Access to care
Time Frame: 18 months
Operationalization see below (outcome measures 16-18).
18 months
Satisfaction with health care
Time Frame: 18 months
Self-developed questionnaire with 13 items
18 months
Use of support services
Time Frame: 18 months
Self-developed questionnaire with 21 items
18 months
Satisfaction with health coordination
Time Frame: 12 months
Case Management questionnaire with 11 items
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal Joint Committee
aQua-Institut GmbH, Germany
Leibniz-Institut für Resilienzforschung, Germany
nestwärme gGmbH, Germany
Kindernetzwerk e.V., Germany
ism gGmbH, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gerald Willms, PhD, aQua-Institut GmbH, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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