Condition category
Not Applicable
Date applied
09/09/2013
Date assigned
18/12/2013
Last edited
18/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of the study is to see how useful it is to have a technically-based assistance system in the houses of older people in order to decrease morbidity and the economic and social consequences of non-intentional lesions at home (home accidents).

Who can participate? :
People who are 75 years old or more, either sexes, with full mental faculties and able to move about by themselves, who are users of the ‘Tele-health’ service (1st generation) residing in selected regions in Spain and who have accepted to participate in the study.

What does the study involve?
Participants are randomly allocated to one of two groups: intervention group or control group.
All participants attend an interview which includes completing a questionnaire about accident rates and home conditions in the 12 months before inclusion in the study/
For the intervention group, a number of devices are installed such as smoke and gas detector, fall detector, bed and armchair pressure detector and presence detector. No devices are installed for the control group.
There is a follow-up visit 6 months in the study and a final visit (same questionnaires).

What are the possible benefits and risks of participating?
Benefits include the early detection of events (falls, burns, etc.) in the home that would lead to the intervention of a provider and/or entry in a healthcare centre.

Where is the study run from?
In 6 regions (autonomous communities) in Spain: Andalucía, Aragón, Cantabria, Castilla y León, Ceuta, Galicia y Murcia.

When is the study starting and how long is it expected to run for?
The study started in July 2011 and is expected to complete in July 2014.

Who is funding the study?
Ministry of Health and Social Affairs (Ministerio de Sanidad y Asuntos Sociales), Spain

Who is the main contact?
Spanish Red Cross (Cruz Roja Española)

Trial website

Contact information

Type

Scientific

Primary contact

Mr Carlos Capataz

ORCID ID

Contact details

Avenida Reina Victoria 26
Madrid
28003
Spain
+34 913354654
carcap@cruzroja.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

23

Study information

Scientific title

Care system in older and disabled peoples' homes based on new technologies: Tele-care II Generation

Acronym

TAD II Generation

Study hypothesis

To evaluate the efficiency of installing a techno-care system in elderly peoples' homes in order to minimise morbidity and also the economic and social costs derived from non-intentioned lesions at home (domestic accidents).

Ethics approval

Ethics Committee and Animal Welfare Research (Comité de Ética de la Investigación y de Bienestar Animal)

Study design

Prospective controlled randomized open two parallel arms (1:1) study

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 the contact details below to request a patient information sheet

Condition

Not applicable

Intervention

Randomization with four stratification criteria in order to select the two groups

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mean number of hospitalizations in each group
2. Mean time of stay in hospital.
The number of hospitalizations and the mean time of stay in hospital will be provided by monitoring and interviewing users and will be corroborated by obtained from Health Records from the healthcare information systems.
3. The quality of life will also be measured from the interviews.
4. The rate of events resulting in the provider going to the house, the stay and use of day centers will be measured from the platform of the social care provider

Secondary outcome measures

1. Mean total cost per person, including health and social care costs
2. Global rate of events (falls, burns, etc) resulting in the provider going to the house or the entry in a healthcare center
3. The entry rate in residences or socio-sanitary centers
4. The rate of use of day centers
5. Quality of life of users and quality of life of (usual) carers
6. The mean time of attention (formal and informal care)

Overall trial start date

01/07/2011

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 75 or more years old, both sexes with good mental faculties
2. Users of Tele-care service 1st generation residing in the community
3. Who accepted to participate in the study (written informed consent)
4. Able to move on and get around by themselves

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

3764

Participant exclusion criteria

1. People who refuse to participate
2. People with terminal condition, immobilized patients, people with psychiatric diseases and / or cognitive deterioration that prevents them from participating in the research (according to the research team in charge in the area)
3. Displaced or institutionalized people
4. People who cannot change position without help and without supervision
5. People who cannot walk or move in their home without help and without supervision
6. People who spend long time periods (more than 3 months) out of their usual residence (e.g. in relatives' houses)

Recruitment start date

01/07/2011

Recruitment end date

30/06/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Avenida Reina Victoria 26
Madrid
28003
Spain

Sponsor information

Organisation

Spanish Red Cross (Spain)

Sponsor details

AVenida Reina Victoria 26
Madrid
28003
Spain
+34 913354654
registro@cruzroja.es

Sponsor type

Charity

Website

http://www.cruzroja.es

Funders

Funder type

Government

Funder name

Project funded by Ministry of Health and Social Affairs (Ministerio de Sanidad y Asuntos Sociales), Spain

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The installed devices belong to the company Tunstal, Spain

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The project provider is the Spanish Red Cross (Cruz Roja Española), Spain

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Several provincial delegations belonging to the 6 autonomous communities participate, Spain

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