Disabled or Chronically Ill Children in Need of CareNESTNCT05418205
Family Health Partners in Regional Network Structures
A study testing Families with FGP support in people with Disabled or Chronically Ill Children in Need of Care, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disabled or Chronically Ill Children in Need of Care
- What is being tested?
- Families with FGP support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kindernetzwerk e.V.
Mainaschaff, D-63814
Nestwärme gGmbH
Trier, D-54290
About this study
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
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.
Read the 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).
- Being tested
- Families with FGP support
- Keywords
- children in need of care, family caregivers, Family Health Partner, non-medical care, regional networking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families with FGP supportOther
Non-randomized controlled trial with four points of measurement ( in 18 months)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Families with FGP support |
| Control Group (CG) | No intervention | Families without FGP support (standard care) under the same conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Parents' mental and physical health
General Health Questionnaire-28 - GHQ-28
Measured: 18 months
Well-being
WHO-Five Well-being Index - WHO-5
Measured: 18 months
Stress experience
Perceived Stress Scale - PSS-4
Measured: 18 months
Family burden due to illness of the child
Impact-on-Family Scale - IOFS-20
Measured: 18 months
Family cohesion
Resilience Scale for Adults - RSA
Measured: 18 months
Resilience
Brief Resilience Scale - BRS
Measured: 18 months
Individual stressor exposure
Mainz Inventory of Microstressors - MIMIS
Measured: 18 months
Life events
Life History Calendar - LHC
Measured: 18 months
Secondary outcomes (9)
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.
Measured: 18 months
Optimism / positive thinking
Scale Optimism-Pessimism-2 - SOP-2
Measured: 18 months
Locus of control
Internal and External Locus of Control Scale-4 - IE-4
Measured: 18 months
Self-efficacy
General Self-efficacy Short Scale - ASKU-3
Measured: 18 months
Social support
Oslo Social Support Scale - OSSS-3
Measured: 18 months
Access to care
Operationalization see below (outcome measures 16-18).
Measured: 18 months
Satisfaction with health care
Self-developed questionnaire with 13 items
Measured: 18 months
Use of support services
Self-developed questionnaire with 21 items
Measured: 18 months
Satisfaction with health coordination
Case Management questionnaire with 11 items
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Apr 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disabled or Chronically Ill Children in Need of CareStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Joint Committee, aQua-Institut GmbH, Germany, Leibniz-Institut für Resilienzforschung, Germany, nestwärme gGmbH, Germany, Kindernetzwerk e.V., Germany, ism gGmbH, Germany
- Responsible party
- Sponsor
- Investigators
- Gerald Willms, PhD, Study director, aQua-Institut GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418205
- Sponsor's protocol ID
- 01VSF20004
- Acronym
- NEST
- Status last verified
- May 2024
- First submitted
- 1 Mar 2022
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Broll J, Ludecke D, Nickel S, Schafer SK, Lieb K, Helmreich I. Personalized case management for caregivers of children with chronic illnesses or disabilities: A non-randomized controlled trial. Int J Nurs Stud. 2026 Jul;179:105541. doi: 10.1016/j.ijnurstu.2026.105541. Epub 2026 Apr 21.
PubMed 42019263Broll 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.
PubMed 40316988Nickel 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.
PubMed 37459306
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05418205
- Acronym / sponsor ID
- NEST / 01VSF20004
- Keywords
- children in need of care, family caregivers, Family Health Partner, non-medical care, regional networking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Federal Joint Committee, aQua-Institut GmbH, Germany, Leibniz-Institut für Resilienzforschung, Germany, nestwärme gGmbH, Germany, Kindernetzwerk e.V., Germany, ism gGmbH, Germany
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Other: Families with FGP supportFamilies with FGP support (families with disabled and/or chronically children under 18 in the greater area of Mainz, Saarbrucken and Munich (Germany) |
| Control Group (CG) | No intervention | –Families without FGP support (standard care) under the same conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Families with FGP supportNon-randomized controlled trial with four points of measurement ( in 18 months) | Other | Intervention Group (IG) |
Primary outcome
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.
Parents' mental and physical health
Time frame: 18 months
General Health Questionnaire-28 - GHQ-28
Well-being
Time frame: 18 months
WHO-Five Well-being Index - WHO-5
Stress experience
Time frame: 18 months
Perceived Stress Scale - PSS-4
Family burden due to illness of the child
Time frame: 18 months
Impact-on-Family Scale - IOFS-20
Family cohesion
Time frame: 18 months
Resilience Scale for Adults - RSA
Resilience
Time frame: 18 months
Brief Resilience Scale - BRS
Individual stressor exposure
Time frame: 18 months
Mainz Inventory of Microstressors - MIMIS
Life events
Time frame: 18 months
Life History Calendar - LHC
9 secondary outcomes
Resilience factors and associated measures
Time frame: 18 months
Optimism / positive thinking
Time frame: 18 months
Locus of control
Time frame: 18 months
Self-efficacy
Time frame: 18 months
Social support
Time frame: 18 months
Access to care
Time frame: 18 months
Satisfaction with health care
Time frame: 18 months
Use of support services
Time frame: 18 months
Satisfaction with health coordination
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 42019263Broll J, Ludecke D, Nickel S, Schafer SK, Lieb K, Helmreich I. Personalized case management for caregivers of children with chronic illnesses or disabilities: A non-randomized controlled trial. Int J Nurs Stud. 2026 Jul;179:105541. doi: 10.1016/j.ijnurstu.2026.105541. Epub 2026 Apr 21.
- Derived from this study: PubMed 40316988Broll 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.
- Derived from this study: PubMed 37459306Nickel 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.
- Research project N.E.S.T.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Willms, PhD study director
aQua-Institut GmbH, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families with FGP support in people with Disabled or Chronically Ill Children in Need of Care, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family quality of life (time frame: 18 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418205, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.