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11 February 2012
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| [ Print-friendly version ] |
| Preventing further falls and functional decline among elderly persons presented to the Accident and Emergency (A&E) department with a fall: randomised controlled trial |
| ISRCTN | ISRCTN64716113 |
| ClinicalTrials.gov identifier | |
| Public title | Preventing further falls and functional decline among elderly persons presented to the Accident and Emergency (A&E) department with a fall: randomised controlled trial |
| Scientific title | |
| Acronym | Interval |
| Serial number at source | 945-02-053 |
| Study hypothesis |
The main objective of our current study is to evaluate the effects of a multidisciplinary intervention programme on recurrent falls and functional decline among elderly persons who have visit a general practitioners' cooperative (GP cooperative) and/or an accident and emergency department (A&E department) because of a fall. This objective has resulted in the following research questions:
1. Is a multidisciplinary intervention programme more effective than usual care in preventing new falls and functional decline among community-dwelling elderly people who visit a GP cooperative and/or A&E department at a hospital because of a fall? 2. Is the multidisciplinary intervention programme cost-effective compared to usual care when assessed from a societal perspective? |
| Lay summary | |
| Ethics approval | The study design and protocols were approved by the Medical Ethics Committee of the University Hospital and University of Maastricht. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Falls |
| Participants - inclusion criteria |
1. Aged 65 years or older
2. Community-dwelling 3. Having visited the A&E department or GP cooperative at the University Hospital Maastricht with consequences resulting from a fall 4. Living in Maastricht or its surroundings |
| Participants - exclusion criteria |
1. Not able to speak or understand Dutch
2. Not able to complete questionnaires or interviews by telephone 3. Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4 (AMT 4) 4. Long-term admission to a hospital or other institution (more than four weeks from the date of inclusion) 5. Permanently bedridden 6. Fully dependent on a wheelchair |
| Anticipated start date | 01/12/2002 |
| Anticipated end date | 01/02/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 328 |
| Interventions |
1. Patients in the intervention group underwent a detailed medical and occupational-therapy assessment with referral to relevant services if indicated
2. Those assigned to the control group received usual care only |
| Primary outcome measure(s) |
1. Number of falls (recorded continuously by means of a fall calendar during the twelve-month follow-up period):
1.1. The percentage of elderly people sustaining a fall during the one-year follow-up period 1.2. Recurrent falls during follow-up (i.e., the percentage of elderly people sustaining two or more falls) 1.3. Injurious falls during follow-up (the percentage of elderly people receiving medical care after a fall) 2. Daily functioning, measured using the Frenchai Activity Index (FAI) at baseline and after four and twelve months |
| Secondary outcome measure(s) |
Secondary outcome measures:
1. Recuperation from the fall 2. Health complaints 3. Perceived health measured by means of the first two items of the RAND 36-Item Health Survey 4. Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) disability measured by means of the Groningen Activity Restriction Scale (GARS) 5. Mental health measured by means of the Hospital Anxiety and Depression Scale (HADS) 6. Quality of life measured by means of the European Quality of Life instrument (EuroQol) The secondary outcome measures are assessed by means of self-administered questionnaires at four and twelve months. |
| Sources of funding | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053) |
| Trial website | |
| Publications | Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15651990 |
| Contact name | Prof Jacques van Eijk |
| Address |
University Maastricht
Medical Sociology P.O. Box 616 |
| City/town | Maastricht |
| Zip/Postcode | 6200 MD |
| Country | Netherlands |
| j.vaneijk@zw.unimaas.nl | |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Address |
Laan van Nieuw Oost Indië 334
P.O. Box 93245 |
| City/town | The Hague |
| Zip/Postcode | 2509 AE |
| Country | Netherlands |
| Tel | +31 (0)70 349 5111 |
| Fax | +31 (0)70 349 5100 |
| info@zonmw.nl | |
| Date applied | 27/08/2004 |
| Last edited | 17/09/2007 |
| Date ISRCTN assigned | 11/10/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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