PreventionPhase 1NCT00250003
Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial
A Phase 1 study testing Preventive home visits in people with Prevention and House Calls, run by Umeå University at 1 site in Sweden.
Trial summary
To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention, House Calls
- What is being tested?
- Preventive home visits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Feb 2000to Dec 2001
- Phase
- Phase 1
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- older than 75 year
- living in their own home
- living in Nordmaling, Sweeden
Who cannot join
- any need of elderly care, long term care or frequent health care
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå University, Epidemiology and Public Health
Umeå, Västerbotten County, 914 05
About this study
Official title: Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial in Nordmaling
To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve.
Read the detailed description
To investigate whether preventive home visits for healthy pensioners aged 75 years and over , can change the pattern of care utilization and if the quality of life can improve. To investigate if the results will last after the intervention has come to an end.
The concept of care utilization can in this trial be clarified as:
- use of primary health care
- use of elderly care including elderly houses
- mortality
- use of hospital care
The concept of quality of life will in this trial be measured with a number of self judgements.
The trial is performed as a randomized controlled trial in a small rural community in the north of Sweden. The staff is professional health workers and the visits is performed in the pensioners own homes.
- Conditions
- Prevention, House Calls
- Being tested
- Preventive home visits
- Keywords
- Elderly, Preventive home visits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive home visitsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
use of health care facilities during two years 2000-2001
all cause mortality during two years 2000 - 2001
Secondary outcomes (2)
use of health care facilities 2002-2004
all cause mortality during 2002-2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startFeb 2000
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Investigators
- Lars Dahlgren, professor, Study chair, Epeidemiology and Public Health, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250003
- Sponsor's protocol ID
- UmU2001:39
- Status last verified
- Sep 2005
- First submitted
- 4 Nov 2005
- Last updated
- 23 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Home Visits for Healthy Pensioners- a Randomized Controlled Trial in Nordmaling
- ClinicalTrials.gov ID
- NCT00250003
- Acronym / sponsor ID
- UmU2001:39
- Conditions
- Prevention, House Calls
- Keywords
- Elderly, Preventive home visits
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Study start
- Feb 2000
- Study completion
- Dec 2001
- First posted
- 7 Nov 2005 (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.
To investigate whether preventive home visits for healthy persons 75+, made by professional health workers, can change the pattern of care utilization and if the quality of life can improve. The hypothesis is that care utilisation will reduce, mortality decrease and quality of life improve.
Detailed description
To investigate whether preventive home visits for healthy pensioners aged 75 years and over , can change the pattern of care utilization and if the quality of life can improve. To investigate if the results will last after the intervention has come to an end.
The concept of care utilization can in this trial be clarified as:
- use of primary health care
- use of elderly care including elderly houses
- mortality
- use of hospital care
The concept of quality of life will in this trial be measured with a number of self judgements.
The trial is performed as a randomized controlled trial in a small rural community in the north of Sweden. The staff is professional health workers and the visits is performed in the pensioners own homes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- older than 75 year
- living in their own home
- living in Nordmaling, Sweeden
Key exclusion criteria (1 listed)
- any need of elderly care, long term care or frequent health care
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 |
|---|---|---|
| Preventive home visits | Behavioural | – |
Primary outcome
use of health care facilities during two years 2000-2001
all cause mortality during two years 2000 - 2001
2 secondary outcomes
use of health care facilities 2002-2004
all cause mortality during 2002-2004
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2005.
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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.
Lars Dahlgren, professor study chair
Epeidemiology and Public Health, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Preventive home visits in people with Prevention and House Calls, run by Umeå University at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 23 Nov 2005. 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 Sweden. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
use of health care facilities during two years 2000-2001. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2005.