Orthostatic HypotensionNCT01362751
Orthostatic Hypotension in Elderly Nursing Home Residents
An observational study of Orthostatic Hypotension, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial summary
In this study the investigators aimed 1. to investigate the prevalence of orthostatic hypotension in elderly nursing home residents. 2. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthostatic Hypotension
- How many people
- 290 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Mar 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nursing home residents
Who may be able to join
- nursing home resident
Who cannot join
- patients at the palliative department
- life expectancy < 4 weeks
- patients only temporarily admitted to the nursing home
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Nursing home TriviumMeulenbeltZorg, location Borsthuis
Hengelo
About this study
In this study the investigators aimed
- to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.
- to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.
- Conditions
- Orthostatic Hypotension
- Being tested
- No intervention
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study is an observational cohort study > no interventions
| Study group | Role | What they receive |
|---|---|---|
| Nursing home residents | In this study, patients from both the somatic and the psychogeriatric department are included. For the primary endpoint 'successful rehabilitation' only the patients from the somatic departments are included. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic hypotension
Orthostatic hypotension is defined by consensus as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes in the upright position
Measured: Baseline
Successful rehabilitation
Successful rehabilitation is defined as whether the patient is able to return to his/her home or another location (but not a nursing home) after discharge from the nursing home. Unsuccessful rehabilitations implies that the patients becomes a long-stay nursing home resident.
Measured: After 5 years
Secondary outcomes (3)
All-cause and Cardiovascular mortality
Measured: Date of death
Quality of life
Quality of life is measured using the RAND-36 questionnaire.
Measured: Measured at baseline and after 1 year
Fall incidents
Measured: After 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornelis J.J. van Hateren, Medical Research Foundation, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362751
- Sponsor's protocol ID
- OH_TMZ_2010
- Status last verified
- Sep 2012
- First submitted
- 7 Oct 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartog LC, Cizmar-Sweelssen M, Knipscheer A, Groenier KH, Kleefstra N, Bilo HJ, van Hateren KJ. The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):190-6. doi: 10.1016/j.archger.2015.05.005. Epub 2015 May 18.
PubMed 26026216
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic Hypotension in Elderly Nursing Home Residents
- ClinicalTrials.gov ID
- NCT01362751
- Acronym / sponsor ID
- OH_TMZ_2010
- Conditions
- Orthostatic Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 May 2011 (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.
In this study the investigators aimed
- to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.
- to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing home residents | – | Other: No interventionIn this study, patients from both the somatic and the psychogeriatric department are included. For the primary endpoint 'successful rehabilitation' only the patients from the somatic departments are included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nursing home residents
Key inclusion criteria (1 listed)
- nursing home resident
Key exclusion criteria (3 listed)
- patients at the palliative department
- life expectancy < 4 weeks
- patients only temporarily admitted to the nursing home
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 |
|---|---|---|
| No interventionThis study is an observational cohort study > no interventions | Other | Nursing home residents |
Primary outcome
Orthostatic hypotension
Time frame: Baseline
Orthostatic hypotension is defined by consensus as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes in the upright position
Successful rehabilitation
Time frame: After 5 years
Successful rehabilitation is defined as whether the patient is able to return to his/her home or another location (but not a nursing home) after discharge from the nursing home. Unsuccessful rehabilitations implies that the patients becomes a long-stay nursing home resident.
3 secondary outcomes
All-cause and Cardiovascular mortality
Time frame: Date of death
Quality of life
Time frame: Measured at baseline and after 1 year
Fall incidents
Time frame: After 5 years
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 5 Sep 2012.
- Derived from this study: PubMed 26026216Hartog LC, Cizmar-Sweelssen M, Knipscheer A, Groenier KH, Kleefstra N, Bilo HJ, van Hateren KJ. The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):190-6. doi: 10.1016/j.archger.2015.05.005. Epub 2015 May 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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 1 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 5 Sep 2012. 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 Netherlands. 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?
Orthostatic hypotension (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT01362751, which also lists 1 linked publication.
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 5 Sep 2012.