Tele-care II Generation
| ISRCTN | ISRCTN58032236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58032236 |
| Secondary identifying numbers | 23 |
- Submission date
- 09/09/2013
- Registration date
- 18/12/2013
- Last edited
- 18/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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)
Contact information
Scientific
Avenida Reina Victoria 26
Madrid
28003
Spain
| Phone | +34 913354654 |
|---|---|
| carcap@cruzroja.es |
Study information
| Study design | Prospective controlled randomized open two parallel arms (1:1) study |
|---|---|
| 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 the contact details below to request a patient information sheet |
| Scientific title | Care system in older and disabled peoples' homes based on new technologies: Tele-care II Generation |
| Study acronym | TAD II Generation |
| Study objectives | 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(s) | Ethics Committee and Animal Welfare Research (Comité de Ética de la Investigación y de Bienestar Animal) |
| Health condition(s) or problem(s) studied | Not applicable |
| Intervention | Randomization with four stratification criteria in order to select the two groups |
| Intervention type | Other |
| 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 study start date | 01/07/2011 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 3764 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/07/2011 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
28003
Spain
Sponsor information
Charity
AVenida Reina Victoria 26
Madrid
28003
Spain
| Phone | +34 913354654 |
|---|---|
| registro@cruzroja.es | |
| Website | http://www.cruzroja.es |
Funders
Funder type
Government
No information available
No information available
No information available
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 |
