The effect of a mobile safety alarm on going outside, feeling safe, fear of falling and quality of life in community living older persons.

ISRCTN	ISRCTN65882886
DOI	https://doi.org/10.1186/ISRCTN65882886
Secondary identifying numbers	N/A

Submission date: 20/07/2010
Registration date: 02/09/2010
Last edited: 02/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sophia de Rooij
Scientific

Academic Medical Center
Department of Internal Medicine, F4-159.1
section of Geriatric Medicine
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	s.e.derooij@amc.uva.nl

Study information

Study design	2 armed randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet.
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
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
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 study start date	16/07/2009
Completion date	31/03/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	100 participants in the intervention group and 100 participants in the control group
Key inclusion criteria	1. Having a home-based alarm 2. Community-dwelling 3. Being able to go outside alone 4. Willingness to participate
Key exclusion criteria	Confined to bed
Date of first enrolment	16/07/2009
Date of final enrolment	31/03/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Sponsor information

City council Amsterdam (Netherlands)
Government

c/o Mrs. N. Siemonsma
Department of Housing, Health and Society (Dienst Wonen, Zorg en Samenleven)
PO Box 1900
Amsterdam
1000 BX
Netherlands

Website	http://www.wzs.amsterdam.nl

Funders

Funder type

Government

City council of Amsterdam (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan