- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00644826
Growing Old at Home
June 1, 2010 updated by: Martin-Luther-Universität Halle-Wittenberg
Growing Old at Home - Effectiveness and Cost-effectiveness of Preventive Home Visits to Reduce Nursing Home Admissions in the Elderly
The purpose of this study is to determine whether preventive home visits for people aged 80 and over are effective in the prevention of nursing home admission in Germany.
Study Overview
Detailed Description
Regarding demographic changes in Germany it can be assumed that the number of elderly and the resulting need for long term care is increasing in the near future.
It is not only an individual's interest but also of public concern to avoid a nursing home admission.
Current evidence indicates that preventive home visits can be an effective way to reduce the admission rate in this way making it possible for elderly people to stay longer at home than without home visits.
As the effectiveness and cost-effectiveness of preventive home visits strongly depends on existing services in the social and health system existing international results cannot be merely transferred to Germany.
Therefore it is necessary to investigate the effectiveness and cost-effectiveness of such an intervention by a randomized controlled trial in Germany.
Study Type
Interventional
Enrollment (Actual)
336
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
-
-
SA
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Leipzig, SA, Germany, 04107
- Klinik und Poliklinik für Psychiatrie, Universitätsklinikum Leipzig AöR
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-
SAN
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Halle, SAN, Germany, 06197
- Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
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-
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
80 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 80
- fluent German speaker
- resident of Leipzig or Halle
- living at home (i.e. no nursing home resident)
Exclusion Criteria:
- cognitive impairment
- not able to give informed consent
- care level higher than 1 according to German long term care insurance
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
|
A multidimensional geriatric assessment within the dimensions: cognition, health related functioning, risk of falling, nutritional status, social situation, economic situation, mood.
Two more home visits: (1) home counseling visit 2-3 weeks after assessment (2) booster session 1 month after home counseling visit
Other Names:
|
No Intervention: 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
nursing home admission rate
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
health care service utilization and costs
Time Frame: 18 months
|
18 months
|
incremental cost-effectiveness and cost- utility ratio
Time Frame: 18 months
|
18 months
|
health related functioning
Time Frame: 18 months
|
18 months
|
health related quality of life
Time Frame: 18 months
|
18 months
|
prevalence of falls
Time Frame: 18 months
|
18 months
|
time to nursing home admission
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Johann Behrens, PhD, Martin-Luther-Universität Halle-Wittenberg
- Principal Investigator: Steffi Riedel-Heller, MD, Universität Leipzig
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
- Brettschneider C, Luck T, Fleischer S, Roling G, Beutner K, Luppa M, Behrens J, Riedel-Heller SG, Konig HH. Cost-utility analysis of a preventive home visit program for older adults in Germany. BMC Health Serv Res. 2015 Apr 3;15:141. doi: 10.1186/s12913-015-0817-0.
- Fleischer S, Roling G, Beutner K, Hanns S, Behrens J, Luck T, Kuske B, Angermeyer MC, Riedel-Heller SG, Heinrich S, Konig HH, Lautenschlager C. Growing old at home - a randomized controlled trial to investigate the effectiveness and cost-effectiveness of preventive home visits to reduce nursing home admissions: study protocol [NCT00644826]. BMC Public Health. 2008 May 28;8:185. doi: 10.1186/1471-2458-8-185.
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
September 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 27, 2008
Study Record Updates
Last Update Posted (Estimate)
June 3, 2010
Last Update Submitted That Met QC Criteria
June 1, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- PfVMS-T5
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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