Condition category
Not Applicable
Date applied
20/07/2010
Date assigned
02/09/2010
Last edited
02/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.wzs.amsterdam.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes