Main
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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:
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ISRCTN |
Last refreshed on:
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13 September 2021 |
Main ID: |
ISRCTN64716113 |
Date of registration:
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11/10/2004 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Preventing further falls and functional decline among elderly persons presented to the Accident and Emergency (A&E) department with a fall: randomised controlled trial
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Scientific title:
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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:
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01/12/2002 |
Target sample size:
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328 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN64716113 |
Study type:
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Interventional |
Study design:
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Randomised controlled trial (Prevention)
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Phase:
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Not Specified
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jacques
van Eijk |
Address:
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University Maastricht
Medical Sociology
P.O. Box 616
6200 MD
Maastricht
Netherlands |
Telephone:
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- |
Email:
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j.vaneijk@zw.unimaas.nl |
Affiliation:
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Telephone:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Falls Injury, Occupational Diseases, Poisoning Falls
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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945-02-053
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Source(s) of Monetary Support
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053)
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Ethics review
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Status:
Approval date:
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/02/2004 |
URL:
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