DementiaNCT00434889
A Study of Why People With Early Memory Problems Fall or Almost Fall
An observational study of Dementia and Falls, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Falls, Near-Falls
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Dec 2009
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- males or females over the age of 50 with early-stage dementia as described by Global Deterioration Scale levels 2,3,4 or 5.
Who cannot join
- subjects who have a medical condition that significantly predispose them to falls (Meneire's disease or Parkinson's disease)
- subjects without a caregiver/spouse to assist with the completion of a Fall Diary
- subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device
- subjects unable to safely complete the balance and gait evaluations.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
School of Physical Therapy, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W3
About this study
Official title: Factors Associated With Falls and Near-Falls in Community Dwelling Older Adults With Early-Stage Dementia
The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.
Read the detailed description
The specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.
- Conditions
- Dementia, Falls, Near-Falls
- Keywords
- dementia, falls, risk factors
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Memory problems | |
| 2 | No memory problems |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startAug 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Investigators
- Vanina Dal Bello-Haas, Ph.D, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434889
- Sponsor's protocol ID
- BIO-REB 06-181
- Status last verified
- Jan 2010
- First submitted
- 13 Feb 2007
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Falls and Near-Falls in Community Dwelling Older Adults With Early-Stage Dementia
- ClinicalTrials.gov ID
- NCT00434889
- Acronym / sponsor ID
- BIO-REB 06-181
- Conditions
- Dementia, Falls, Near-Falls
- Keywords
- dementia, falls, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- Aug 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Feb 2007 (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.
The purpose of this study is to identify the factors that are associated with falls and near falls in community-dwelling older adults with early-stage dementia.
Detailed description
The specific objectives of this six month study are to: characterize falls and near-falls in community dwelling older adults with early-stage dementia; determine which potentially modifiable physical fall risk factors contribute to falls and near-falls in older adults with early-stage dementia; examine the relationship between dementia sub-type, medical and neuropsychological factors, balance and gait, and falls and near-falls in community dwelling older adults with early-stage dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Memory problems |
| 2 | – | –No memory problems |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- males or females over the age of 50 with early-stage dementia as described by Global Deterioration Scale levels 2,3,4 or 5.
Key exclusion criteria (4 listed)
- subjects who have a medical condition that significantly predispose them to falls (Meneire's disease or Parkinson's disease)
- subjects without a caregiver/spouse to assist with the completion of a Fall Diary
- subjects unable to stand independently or safely walk a short distance either unaided or with the support of an assistive device
- subjects unable to safely complete the balance and gait evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
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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.
Vanina Dal Bello-Haas, Ph.D principal investigator
University of Saskatchewan
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 Dementia and Falls, run by University of Saskatchewan at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2010. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanina Dal Bello-Haas, Ph.D (306-966-6570, vanina.dalbello-haas@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Jan 2010.