- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00734942
Development and Implementation of Evidence-Based Family-Oriented Support for Young Carers and Their Families in Germany
December 22, 2008 updated by: University of Witten/Herdecke
Improved Health-Related Quality of Life for Young Carers and Their Families in Germany on the Basis of Evidence-Based Family-Oriented Support
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- 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 Locations
-
-
NRW
-
Witten, NRW, Germany, 58453
- Institute of Nursing Science
-
-
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
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children of mentally ill parents (chronic illness)
- children of somatically ill parents (chronic illness)
Exclusion Criteria:
- children of drug addicted parents
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
intervention group
|
|
|
No Intervention: 2
waiting group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
health-related Quality of Life in children
Time Frame: study start and after 5 month of intervention
|
study start and after 5 month of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sabine Metzing-Blau, Dr., Institute of Nursing Science; Witten/Herdecke University
- Study Director: Wilfried Schnepp, Prof.Dr., Institute of Nursing Science; Witten/Herdecke University
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.
General Publications
- 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.
- 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.
- 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.
- 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.
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
January 1, 2009
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
March 1, 2010
Study Registration Dates
First Submitted
August 12, 2008
First Submitted That Met QC Criteria
August 12, 2008
First Posted (Estimate)
August 14, 2008
Study Record Updates
Last Update Posted (Estimate)
December 23, 2008
Last Update Submitted That Met QC Criteria
December 22, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GT0619
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.