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Research into prevention of medication induced fall incidents.


- candidate number4746
- NTR NumberNTR1593
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2008
- Secondary IDsNL23970.078.08 CCMO
- Public TitleResearch into prevention of medication induced fall incidents.
- Scientific Title[Cost]effectiveness of medication withdrawal in older fallers: a randomized controlled trial at the Accident and Emergency Department.
- ACRONYMImproveFALL
- hypothesisThe withdrawal, reduction or substitution of fall-risk increasing drugs will reduce fall risk in the elderly.
- Healt Condition(s) or Problem(s) studiedFall injuries
- Inclusion criteria1. Fall according to the specified definition;
2. Using at least 1 fall-risk increasing drug;
3. Community-dwelling;
4. Age 65 years or older;
5. Independently ambulant;
6. MMSE 21 points or higher;
7. Informed consent.
- Exclusion criteria1. Fall not meeting criteria of specified definition;
2. Not using fall-risk increasing drugs;
3. Not community-dwelling (e.g. living in nursing home);
4. Age <65 years;
5. Not independently ambulant;
6. MMSE <21 points;
7. No informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-okt-2008
- planned closingdate27-okt-2011
- Target number of participants620
- InterventionsIntervention group:
systematic fall-related drugs assessment combined with drug modification.
Control group:
systematic fall-related drug assessment without subsequent drug modification.
- Primary outcome1. Incidence of further falls;
2. Negative health effects;
3. Costs per prevented fall.
- Secondary outcome1. Fall-related injuries;
2. Generic HRQOL;
3. Compliance;
4. Quality Adjusted Life Years;
5. Genetic polymorphisms;
6. Costs per prevented fall-related injury;
7. Costs per QALY.
- Timepoints- t=0: Baseline fall-related (drug) assessment;
- t=3, 6, 9, 12 months: fall / health questionnaire;
- t=12 months: final fall-related assessment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. MD, PhD, FRCP T.J.M. Cammen, van der
- CONTACT for SCIENTIFIC QUERIESDr. MD, PhD, FRCP T.J.M. Cammen, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryObjective/ research questions:
To evaluate the effects and cost-effectiveness of a systematic drug assessment and drug modification in older fallers presenting at the Emergency Department (ED). Based on the results of this study, a clinical protocol will be developed for assessment and modification of drug use among older fallers at the ED.

Study design:
RCT with one intervention and one control group. Older fallers (65+) presenting at the ED, and on 1 or more fall-risk increasing drugs, are eligible. In total 620 patients will be randomized. The intervention group will receive a systematic drug assessment. Fall-risk increasing drugs will be stopped, reduced or substituted by safer drugs where possible. The control group will receive usual care and a systematic drug assessment without drug modification. During 1 year of follow-up, fall incidence, fall-related injuries, medication use, recurrence of (disease)symptoms, and health care consumption (costs) will be registered. Also, patients will complete health-related quality of life questionnaires (SF-12v2 and EQ-5D).

Outcome measures:
Primary outcome parameters will be the incidence of further falls and the possible negative health outcomes of drug withdrawal.
Secondary outcome measures will be fall-related injuries, generic health-related quality of life (HRQOL), compliance and quality adjusted life years.

Data analysis:
The intention-to-treat principle will be followed. The hazard ratio (HR) for falling will be calculated with Cox-regression analyses using the time between the intervention till the first/second fall as the outcome measure.

Economic evaluation:
Cost-effectiveness analysis, including costs per prevented fall as primary outcome measure, and costs per prevented fall-related injury and costs per QALY as secondary outcome measures.
- Main changes (audit trail)
- RECORD16-dec-2008 - 1-apr-2009


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