Chronic IllnessNCT00734942
Development and Implementation of Evidence-Based Family-Oriented Support for Young Carers and Their Families in Germany
A study testing support service in people with Chronic Illness, run by University of Witten/Herdecke at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Illness
- What is being tested?
- support service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Mar 2010
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children of mentally ill parents (chronic illness)
- children of somatically ill parents (chronic illness)
Who cannot join
- children of drug addicted parents
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nursing Science
Witten, North Rhine-Westphalia, 58453
Sabine Metzing-Blau, Dr., 00492302926 ext. 377, smetzing@uni-wh.de
Joerg grosse Schlarmann, MScN, 00492302926 ext. 377, schlarmann@uni-wh.de
About this study
Official title: 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.
- Conditions
- Chronic Illness
- Being tested
- support service
- Keywords
- young carers, family support, children (up to the age of 18) of chronically ill parents
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | intervention group Receives: Other: support service |
| 2 | No intervention | waiting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
health-related Quality of Life in children
Measured: study start and after 5 month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Investigators
- Sabine Metzing-Blau, Dr., Principal investigator, Institute of Nursing Science; Witten/Herdecke UniversityWilfried Schnepp, Prof.Dr., Study director, Institute of Nursing Science; Witten/Herdecke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734942
- Sponsor's protocol ID
- 01GT0619
- Status last verified
- Aug 2008
- First submitted
- 12 Aug 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18357746Sabine 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.
PubMed 18357745Schlarmann 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.
PubMed 19091099Schlarmann 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.
PubMed 22135716
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Health-Related Quality of Life for Young Carers and Their Families in Germany on the Basis of Evidence-Based Family-Oriented Support
- ClinicalTrials.gov ID
- NCT00734942
- Acronym / sponsor ID
- 01GT0619
- Conditions
- Chronic Illness
- Keywords
- young carers, family support, children (up to the age of 18) of chronically ill parents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 14 Aug 2008 (estimated)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: support serviceintervention group |
| 2 | No intervention | –waiting group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children of mentally ill parents (chronic illness)
- children of somatically ill parents (chronic illness)
Key exclusion criteria (1 listed)
- children of drug addicted parents
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 |
|---|---|---|
| support service* 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 | Other | 1 |
Primary outcome
health-related Quality of Life in children
Time frame: study start and after 5 month of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
- Background: PubMed 18357746Metzing 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.
- Background: PubMed 18357745Sabine 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.
- Background: PubMed 19091099Schlarmann 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.
- Derived from this study: PubMed 22135716Schlarmann 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.
- Website of the studyLink provided by the sponsor.
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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.
Sabine Metzing-Blau, Dr. principal investigator
Institute of Nursing Science; Witten/Herdecke University
Wilfried Schnepp, Prof.Dr. study director
Institute of Nursing Science; Witten/Herdecke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing support service in people with Chronic Illness, run by University of Witten/Herdecke at 1 site 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 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Sabine Metzing-Blau, Dr. (00492302926 ext. 377, smetzing@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health-related Quality of Life in children (time frame: study start and after 5 month of intervention). 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 NCT00734942, which also lists 4 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 23 Dec 2008.