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ISRCTN
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ISRCTN65882886
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ClinicalTrials.gov identifier
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Public title
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The effect of a mobile safety alarm on going outside, feeling safe, fear of falling and quality of life in community living older persons.
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Scientific title
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The effect of a mobile safety alarm on going outside, feeling safe, fear of falling and quality of life in community living older persons: A randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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What is the effectiveness of a mobile alarm in changing the frequency of going outside of older people and what are their experiences about safety, fear of falling and quality of life?
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Lay summary
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Ethics approval
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The Medical Ethical Committee of University of Amsterdam/Academic Medical Centre Amsterdam reviewed this study and confirmed that as a social study, it did not require ethics approval.
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Study design
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2 armed randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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New communication technology and services for older persons
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Participants - inclusion criteria
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1. Having a home-based alarm
2. Community-dwelling
3. Being able to go outside alone
4. Willingness to participate
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Participants - exclusion criteria
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Confined to bed
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Anticipated start date
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16/07/2009
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Anticipated end date
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31/03/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet.
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Target number of participants
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100 participants in the intervention group and 100 participants in the control group
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Interventions
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The intervention consisted of a mobile safety alarm with an inbuilt drop sensor. The mobile alarm was a prototype in development and uses a positioning system patented Europe-wide. The alarm went off by pressing a button. An integrated hand free function allowed the user to speak to personnel of an emergency call centre, even if the user didn’t hold the device at their ear. If the user had fallen, the system automatically registered this and independently made a voice call to the emergency call centre. The Butler used a new kind of positioning system. The user of the alarm was located in 3 steps: their rough location was found via the cell phone network: from close-range, their position was pinpointed via an integrated tracking device and a beeping sound emitted from the device. This procedure allowed first-aiders to reliably find someone, even where conventional positioning systems such as GPS fail, such as in buildings or underground garages.
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Primary outcome measure(s)
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Primary outcome measure was change in the frequency of going outside. The frequency of going outside will be assessed in a telephone interviews at baseline and at 1, 2, 4 and 6 months follow-up.
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Secondary outcome measure(s)
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The following secondary outcomes will be assessed in a telephone interview at baseline, and at 1, 2, 4 and 6 months follow-up:
1. Fear of Falling (Visual Analogue Scale [VAS]-FOF)
2. Unsafe feelings (VAS for Feeling Unsafe)
3. Quality of Life (VAS-EQ-5D).
4. Falls (data on falls were collected prospectively with use of fall calendars)
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Sources of funding
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City council of Amsterdam (Netherlands)
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Trial website
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Publications
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Contact name
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Dr
Sophia
de Rooij
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Address
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Academic Medical Center
Department of Internal Medicine, F4-159.1
section of Geriatric Medicine
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Email
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s.e.derooij@amc.uva.nl
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Sponsor
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City council Amsterdam (Netherlands)
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Address
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c/o Mrs. N. Siemonsma
Department of Housing, Health and Society (Dienst Wonen, Zorg en Samenleven)
PO Box 1900
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City/town
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Amsterdam
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Zip/Postcode
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1000 BX
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Country
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Netherlands
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Sponsor website:
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http://www.wzs.amsterdam.nl
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Date applied
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20/07/2010
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Last edited
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02/09/2010
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Date ISRCTN assigned
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02/09/2010
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