Anticholinergic Side EffectsPRADANCT00854438
Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes
A study testing Multidisciplinary drug reviews by pharmacist and physician in people with Anticholinergic Side Effects, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticholinergic Side Effects
- What is being tested?
- Multidisciplinary drug reviews by pharmacist and physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.
Who cannot join
- Not able to perform the testes because of physical or psychiatric illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist-initiated Reduction of Anticholinergic Drug Activity
Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms.
Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.
Read the detailed description
Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.
- Conditions
- Anticholinergic Side Effects
- Being tested
- Multidisciplinary drug reviews by pharmacist and physician
- Keywords
- anticholinergic drugs, adverse events, elderly, clinical pharmacist, Evaluate the clinical effects of reducing anticholinergic in elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary drug reviews by pharmacist and physicianOther
Reduction of anticholinergic drug effects by pharmacist review
| Study group | Role | What they receive |
|---|---|---|
| Active treatment arm | Experimental | Reduction of anticholinergic drug effects by pharmacist review Receives: Other: Multidisciplinary drug reviews by pharmacist and physician |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CERADS word list measuring immediately and delayed recall
Measured: 4 years
Secondary outcomes (6)
Mouth dryness
Measured: 4 years
ADL
Measured: 4 years
Serum anticholinergic activity
Measured: 4 years
CERADS word list recognition
Measured: 4 years
MMSE
Measured: 4 years
NPI
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticholinergic Side EffectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Directorate of Health
- Responsible party
- Principal investigator, Torgeir Bruun Wyller, Oslo University Hospital
- Investigators
- Torgeir B. Wyller, Professor, Study director, Ullevaal University HospitalHege Kersten, MScPharm/PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854438
- Sponsor's protocol ID
- 1110
- Acronym
- PRADA
- Status last verified
- Jun 2015
- First submitted
- 23 Feb 2009
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-initiated Reduction of Anticholinergic Drug Activity
- ClinicalTrials.gov ID
- NCT00854438
- Acronym / sponsor ID
- PRADA / 1110
- Conditions
- Anticholinergic Side Effects
- Keywords
- anticholinergic drugs, adverse events, elderly, clinical pharmacist, Evaluate the clinical effects of reducing anticholinergic in elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, Norwegian Directorate of Health
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Mar 2009 (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.
Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms.
Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.
Detailed description
Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly. Pathophysiological changes in Alzheimer's dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm | Experimental | Other: Multidisciplinary drug reviews by pharmacist and physicianReduction of anticholinergic drug effects by pharmacist review |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.
Key exclusion criteria (1 listed)
- Not able to perform the testes because of physical or psychiatric illnesses.
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 |
|---|---|---|
| Multidisciplinary drug reviews by pharmacist and physicianReduction of anticholinergic drug effects by pharmacist review | Other | Active treatment arm |
Primary outcome
CERADS word list measuring immediately and delayed recall
Time frame: 4 years
6 secondary outcomes
Mouth dryness
Time frame: 4 years
ADL
Time frame: 4 years
Serum anticholinergic activity
Time frame: 4 years
CERADS word list recognition
Time frame: 4 years
MMSE
Time frame: 4 years
NPI
Time frame: 4 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 19 Jun 2015.
Related trials for Anticholinergic Side Effects
Not yet recruitingObservational study
Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration
Frailty in Older Adults, Functional Decline
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.
Torgeir B. Wyller, Professor study director
Ullevaal University Hospital
Hege Kersten, MScPharm/PhD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary drug reviews by pharmacist and physician in people with Anticholinergic Side Effects, run by Ullevaal University Hospital at 1 site in Norway.
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 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 19 Jun 2015. 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 Norway. 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?
CERADS word list measuring immediately and delayed recall (time frame: 4 years). 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 Jun 2015.