PolypharmacyNCT03024541
Longitudinal Analysis of Drug Burden Index
An observational study of Polypharmacy and Anticholinergics, run by University of Groningen.
Trial summary
Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Anticholinergics, Hypnotics and Sedatives
- How many people
- 9,985 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 55 years and older, both community-dwelling individuals and individuals living in residential aged care facilities
Who may be able to join
- 55 years and older
- 55 years or older
Who cannot join
- problem drinkers in the past and the present
- very severe vision and hearing problems
- InterRAI:
- consumption of 5 or more units of alcohol on one occasion
- unknown sex or age
About this study
Official title: Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index
Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants > 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.
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 |
|---|---|---|
| LASA study | Not described | |
| InterRAI consortium | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
LASA study: Alphabet Coding Task
Measured: 21 years: 7 waves separated by 3 year intervals
Secondary outcomes (12)
LASA study: Mini Mental Status Examination
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: Verbal Fluency Test: Phonemic fluency
Measured: collected at 7th wave after 21 years (cross-sectional)
LASA study: Verbal Fluency Test: Semantic fluency
Measured: collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale
Measured: collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale
Measured: collected at 7th wave after 21 years (cross-sectional)
LASA study: 15-Words Test: Word Learning
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: 15-Words Test: Delayed Recall
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: Functional Independence Scale
Measured: 18 years: 6 waves with 3 year intervals
LASA study: Chair Stands Test
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: Walking Test
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: Cardigan Test
Measured: 21 years: 7 waves separated by 3 year intervals
LASA study: Balance Test
Measured: 21 years: 7 waves separated by 3 year intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies 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
- 9,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Taxis, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024541
- Sponsor's protocol ID
- DBI InterRAI LASA
- Status last verified
- Jan 2017
- First submitted
- 18 Oct 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index
- ClinicalTrials.gov ID
- NCT03024541
- Acronym / sponsor ID
- DBI InterRAI LASA
- Conditions
- Polypharmacy, Anticholinergics, Hypnotics and Sedatives, Cognitive Function, Physical Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,985 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Jan 2017 (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.
Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants > 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LASA study | – | – |
| InterRAI consortium | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 55 years and older, both community-dwelling individuals and individuals living in residential aged care facilities
Key inclusion criteria (2 listed)
- 55 years and older
- 55 years or older
Key exclusion criteria (5 listed)
- problem drinkers in the past and the present
- very severe vision and hearing problems
- consumption of 5 or more units of alcohol on one occasion
- unknown sex or age
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
LASA study: Alphabet Coding Task
Time frame: 21 years: 7 waves separated by 3 year intervals
12 secondary outcomes
LASA study: Mini Mental Status Examination
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: Verbal Fluency Test: Phonemic fluency
Time frame: collected at 7th wave after 21 years (cross-sectional)
LASA study: Verbal Fluency Test: Semantic fluency
Time frame: collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale
Time frame: collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale
Time frame: collected at 7th wave after 21 years (cross-sectional)
LASA study: 15-Words Test: Word Learning
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: 15-Words Test: Delayed Recall
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: Functional Independence Scale
Time frame: 18 years: 6 waves with 3 year intervals
LASA study: Chair Stands Test
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: Walking Test
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: Cardigan Test
Time frame: 21 years: 7 waves separated by 3 year intervals
LASA study: Balance Test
Time frame: 21 years: 7 waves separated by 3 year intervals
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 19 Jan 2017.
- Individual participant dataSharing planned: Undecided. Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy and Anticholinergics, run by University of Groningen.
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 2 inclusion and 5 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
LASA study: Alphabet Coding Task (time frame: 21 years: 7 waves separated by 3 year intervals). 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 19 Jan 2017.