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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list