|- candidate number||1182|
|- NTR Number||NTR113|
|- Date ISRCTN created||11-okt-2004|
|- date ISRCTN requested|
|- Date Registered NTR||12-aug-2005|
|- Secondary IDs||ZON-MW 945-02-053 |
|- 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||Preventing further falls and functional decline among elderly persons presented to the accident and emergency (A&E) department with a fall: randomised controlled trial.|
|- hypothesis||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?
|- Healt Condition(s) or Problem(s) studied||Fall injuries|
|- Inclusion criteria||Age 65 years or older, community-dwelling, having visited the A&E department or GP cooperative at the University Hospital Maastricht for the consequences of a fall, and living in Maastricht or its surrounding area. |
People were only allowed to enter the programme after completing and returning an informed consent form.
|- Exclusion criteria||Not able to speak or understand Dutch,|
Not able to complete questionnaires or interviews by telephone,
Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4 (AMT 4),
Long-term admission to a hospital or other institution (more than four weeks from the date of inclusion),
Permanently bedridden, or fully dependent on a wheelchair.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-dec-2002|
|- planned closingdate||31-okt-2008|
|- Target number of participants||333|
|- 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||1. Effect evaluation: Falls, functional decline;|
2. Economic evaluation: programme costs, healthcare costs and patient and family costs.
2a. Cost Effectiveness Analysis: percentage of people sustaining a fall during one year of follow-up.
2b.Cost Utility Analysis: generic health-related quality of life descriptions, measured according to the standard Dutch version of the EuroQol (EQ 5-D).
|- Secondary outcome||1. Recuperation from the fall, health complaints, perceived health measured by means of the first two items of the RAND-36;|
2. ADL and IADL disability measured by means of the GARS (Groningen Activity Restriction Scale);
3. Mental health measured by means of the HADS (Hospital Anxiety and Depression Scale);
4. Quality of life measured by means of the European Quality of Life instrument (EuroQol).
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Marike Hendriks |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.Th.M. Eijk, van|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Publications||Hendriks MR, van Haastregt JC, Diederiks JP, Evers SM, Crebolder HF, van Eijk JT: Effectiveness and cost-effectiveness of a multidisciplinary intervention programme to prevent new falls and functional decline among elderly persons at risk: design of a replicated randomised controlled trial [ISRCTN64716113]. BMC Public Health 2005, 5(1):6. http://www.biomedcentral.com/1471-2458/5/6
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||5-aug-2005 - 13-dec-2006|