NCT00734942

Brief Summary

The purpose of this study is to develop and implement evidence-based and family-oriented support for young carers and their families in Germany. Hypothesis is that families' own support mechanisms, combined with externally provided support that is determined by the families' specific needs, will help to overcome their burden and enable families to live in the way they wish to despite chronic illness. This will lead to a measurable increase in HRQOL of children concerned.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 23, 2008

Status Verified

August 1, 2008

Enrollment Period

11 months

First QC Date

August 12, 2008

Last Update Submit

December 22, 2008

Conditions

Chronic Illness

Keywords

young carersfamily supportchildren (up to the age of 18) of chronically ill parents

Outcome Measures

Primary Outcomes (1)

  • health-related Quality of Life in children

    study start and after 5 month of intervention

Study Arms (2)

1

EXPERIMENTAL

intervention group

Other: support service

2

NO INTERVENTION

waiting group

Interventions

support serviceOTHER

* professional partners for communication * befriending with other families concerned * information and education (about illness, symptoms, first aid, caring) * free-time activities and time out * homework assistance * administrative advise * support for everyday life

1

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children of mentally ill parents (chronic illness)
  • children of somatically ill parents (chronic illness)

You may not qualify if:

  • children of drug addicted parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nursing Science

Witten, North Rhine-Westphalia, 58453, Germany

Location

Related Publications (4)

  • Metzing S, Schnepp W. [The impact of caring on young carer's lives. An international literature review (1990-2006)]. Pflege. 2007 Dec;20(6):331-6. doi: 10.1024/1012-5302.20.6.331. German.

    PMID: 18357746BACKGROUND

  • Sabine M, Schnepp W. [Children and adolescents as caregivers: who they are and what they do. An international literature review (1990-2006)]. Pflege. 2007 Dec;20(6):323-30. doi: 10.1024/1012-5302.20.6.323. German.

    PMID: 18357745BACKGROUND

  • Schlarmann JG, Metzing-Blau S, Schnepp W. The use of health-related quality of life (HRQOL) in children and adolescents as an outcome criterion to evaluate family oriented support for young carers in Germany: an integrative review of the literature. BMC Public Health. 2008 Dec 17;8:414. doi: 10.1186/1471-2458-8-414.

    PMID: 19091099BACKGROUND

  • Schlarmann JG, Metzing S, Schoppmann S, Schnepp W. Germany's First Young Carers Project's Impact on the Children: Relieving the Entire Family. A Qualitative Evaluation. Open Nurs J. 2011;5:86-94. doi: 10.2174/1874434601105010086. Epub 2011 Oct 26.

    PMID: 22135716DERIVED

Related Links

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sabine Metzing-Blau, Dr.

    Institute of Nursing Science; Witten/Herdecke University

    PRINCIPAL INVESTIGATOR

  • Wilfried Schnepp, Prof.Dr.

    Institute of Nursing Science; Witten/Herdecke University

    STUDY DIRECTOR

Central Study Contacts

Sabine Metzing-Blau, Dr.

CONTACT

00492302926smetzing@uni-wh.de

Joerg grosse Schlarmann, MScN

CONTACT

00492302926schlarmann@uni-wh.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

December 23, 2008

Record last verified: 2008-08

Locations

DE(1)