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AgingNCT00644826

Growing Old at Home

A study testing preventive home visit in people with Aging, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Aging
What is being tested?
preventive home visit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
2 sitesGermany
Study dates
Sep 2007to 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 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • older than 80
  • fluent German speaker
  • resident of Leipzig or Halle
  • living at home (i.e. no nursing home resident)

Who cannot join

  • cognitive impairment
  • not able to give informed consent
  • care level higher than 1 according to German long term care insurance

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg

    Halle, SAN, 06197

  • Klinik und Poliklinik für Psychiatrie, Universitätsklinikum Leipzig AöR

    Leipzig, SA, 04107

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Aging
Being tested
preventive home visit
Keywords
randomized controlled trial, public health, Preventive Health Services

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preventive home visitBehavioural

    Also called geriatric assessment

    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

Study groups in NCT00644826
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Behavioral: preventive home visit
2No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nursing home admission rate

    Measured: 18 months

Secondary outcomes (6)

  1. health care service utilization and costs

    Measured: 18 months

  2. incremental cost-effectiveness and cost- utility ratio

    Measured: 18 months

  3. health related functioning

    Measured: 18 months

  4. health related quality of life

    Measured: 18 months

  5. prevalence of falls

    Measured: 18 months

  6. time to nursing home admission

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

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
Outcomes assessor
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00644826
Sponsor's protocol ID
PfVMS-T5
Status last verified
Jan 2010
First submitted
26 Mar 2008
Last updated
3 Jun 2010
Results posted
No
Data monitoring committee
No

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.

    PubMed 25884452

  • 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.

    PubMed 18507840

Questions about this trial

What is this clinical trial studying?

A study testing preventive home visit in people with Aging, run by Martin-Luther-Universität Halle-Wittenberg at 2 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nursing home admission rate (time frame: 18 months). 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 NCT00644826, which also lists 2 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 3 Jun 2010.

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