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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00644826
Other study ID # PfVMS-T5
Secondary ID
Status Completed
Phase N/A
First received March 26, 2008
Last updated June 1, 2010
Start date September 2007
Est. completion date March 2010

Study information

Verified date January 2010
Source Martin-Luther-Universität Halle-Wittenberg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 336
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
preventive home visit
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

Locations

Country Name City State
Germany Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg Halle SAN
Germany Klinik und Poliklinik für Psychiatrie, Universitätsklinikum Leipzig AöR Leipzig SA

Sponsors (2)

Lead Sponsor Collaborator
Martin-Luther-Universität Halle-Wittenberg German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary nursing home admission rate 18 months No
Secondary health care service utilization and costs 18 months No
Secondary incremental cost-effectiveness and cost- utility ratio 18 months No
Secondary health related functioning 18 months No
Secondary health related quality of life 18 months No
Secondary prevalence of falls 18 months No
Secondary time to nursing home admission 18 months No
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