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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 September 2021
Main ID:  ISRCTN64716113
Date of registration: 11/10/2004
Prospective Registration: No
Primary sponsor: The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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
Date of first enrolment: 01/12/2002
Target sample size: 328
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN64716113
Study type:  Interventional
Study design:  Randomised controlled trial (Prevention)  
Phase:  Not Specified
Countries of recruitment
Netherlands
Contacts
Name: Jacques    van Eijk
Address:  University Maastricht Medical Sociology P.O. Box 616 6200 MD Maastricht Netherlands
Telephone: -
Email: j.vaneijk@zw.unimaas.nl
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Falls
Injury, Occupational Diseases, Poisoning
Falls
Intervention(s)

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(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(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.
Secondary ID(s)
945-02-053
Source(s) of Monetary Support
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available: Yes
Date Posted:
Date Completed: 01/02/2004
URL:
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