Contact information
Type
Scientific
Primary contact
Dr Sophia de Rooij
ORCID ID
Contact details
Academic Medical Center
Department of Internal Medicine
F4-159.1
section of Geriatric Medicine
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
s.e.derooij@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
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?
Ethics approval
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.
Study design
2 armed randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
New communication technology and services for older persons
Intervention
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 didnt 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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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.
Secondary outcome measures
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)
Overall trial start date
16/07/2009
Overall trial end date
31/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Having a home-based alarm
2. Community-dwelling
3. Being able to go outside alone
4. Willingness to participate
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
100 participants in the intervention group and 100 participants in the control group
Participant exclusion criteria
Confined to bed
Recruitment start date
16/07/2009
Recruitment end date
31/03/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
City council Amsterdam (Netherlands)
Sponsor details
c/o Mrs. N. Siemonsma
Department of Housing
Health and Society (Dienst Wonen
Zorg en Samenleven)
PO Box 1900
Amsterdam
1000 BX
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City council of Amsterdam (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list