|- candidate number||4746|
|- NTR Number||NTR1593|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-dec-2008|
|- Secondary IDs||NL23970.078.08 CCMO|
|- Public Title||Research 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.|
|- hypothesis||The withdrawal, reduction or substitution of fall-risk increasing drugs will reduce fall risk in the elderly.|
|- Healt Condition(s) or Problem(s) studied||Fall injuries|
|- Inclusion criteria||1. Fall according to the specified definition; |
2. Using at least 1 fall-risk increasing drug;
4. Age 65 years or older;
5. Independently ambulant;
6. MMSE 21 points or higher;
7. Informed consent.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-okt-2008|
|- planned closingdate||27-okt-2011|
|- Target number of participants||620|
|- Interventions||Intervention group: |
systematic fall-related drugs assessment combined with drug modification.
systematic fall-related drug assessment without subsequent drug modification.
|- Primary outcome||1. Incidence of further falls;|
2. Negative health effects;
3. Costs per prevented fall.
|- Secondary outcome||1. Fall-related injuries;|
2. Generic HRQOL;
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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. MD, PhD, FRCP T.J.M. Cammen, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. MD, PhD, FRCP T.J.M. Cammen, van der|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objective/ 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.
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).
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.
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.
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)|
|- RECORD||16-dec-2008 - 1-apr-2009|