Home-Based Technologies Coupled to Teleassistance Service in the Elderly (DOMOLIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01697553|
Recruitment Status : Unknown
Verified April 2015 by University Hospital, Limoges.
Recruitment status was: Recruiting
First Posted : October 2, 2012
Last Update Posted : April 3, 2015
The growth of the elderly population is associated with the autonomy failure and the increase of dependence problems. Fall incidents are the third cause of chronic disablement in older persons and are one of the major risk factors for entering in dependence.
The recent progress in home technologies and medical care are opportunities to search how to apply these tools to reduce and prevent falling at home.
The purpose of this study is to evaluate the cost effectiveness of simple home automation pack coupled to teleassistance service for preventing home falls in frail elderly population.
1200 patients will be enrolled and randmosied within two arms:
- home with automation pack coupled to teleassistance service
- home without this technology
|Condition or disease||Intervention/treatment||Phase|
|Disablement in the Elderly||Other: home automation pack coupled to teleassistance service Other: Home without automation pack coupled to teleassistance service||Not Applicable|
This study is one of the first European randomized studies using the criteria MAST (Model for Assessment of Telemedicine) for medico-economic evaluation of technology solutions for the prevention and care in the elderly. The medico-economic evaluation of the overall contribution of home automation kit associated with telecare will be conducted in accordance with the recommendations of the research program Renewing Health FP7 the European Union. This program has developed an analytical model common to all evaluations of telemedicine applications that have an impact on health.
. The home-based technology in this study will be a simple home automation pack coupled to teleassistance service. The automation pack will include: a remote intercom, an electronic bracelet or pendentive, a pull shower in the bathroom, a light path, a smoke detector and a gas detector in the kitchen. The central hotline will provide telephone support at all times.
Intercom is a remote transmitter which enables the platform to provide remote assistance with the elderly at home.
Each person will have electronic bracelet or pendentive with a medallion which will be provided with the dialer. It is a system that allows remote assistance to the elderly by pressing the central medallion of the device to request assistance or report a dangerous situation (risk of falling, or fall) to the platform of teleassistance.
The bathroom alarm zipper is a device installed in the shower that allows subjects to use it when at risk of falling or fall detection. The shower is a high risk of fall for the elderly due to movements very often results in an imbalance of seniors already weakened by aging.
The light path is a 1.5 m device installed near the bed and turns automatically on when the person sets foot on the ground. It can provide adapted visibility by showing the right path and improving consciousness.
The smoke and gas detector are devices installed on the ceiling of the kitchen. They allow respectively detecting abnormally high rates of smoke or a gas leak in the house or apartment.
The teleassistance platform is a central technical hotline located in Creuse area. It is functional at any time. All electronic devices are connected to the plant. An alert is signaled by an alarm, involving an immediate phone call to the resident of the house to assess the situation. The resulting actions taken are either reassuring the person, giving directions to the person or sending a message to aid in the event ascertained or suspected.
A monthly questionnary should be filled by patients.
The main judgment criterion will be the cumulated incidence of home falls requiring emergency admission.
- Changes score ISO profile resource according to SMAF scale,
- Proportion of participants with regular physical activity
- Effect on admissions in institutions (nursing homes or senior residential care)
- Time before management of stroke and the length of stay in rehabilitation unit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||June 2016|
|Experimental: Home automation pack coupled to teleassistance service||
Other: home automation pack coupled to teleassistance service
|Active Comparator: Home without automation pack coupled to teleassistance service||
Other: Home without automation pack coupled to teleassistance service
- incidence of home falls requiring emergency admission [ Time Frame: at 12 months ]The cumulated incidence of home falls requiring emergency admission.
- Changes score ISO profile resource according to SMAF scale [ Time Frame: at 12 months ]
- Proportion of participants with regular physical activity [ Time Frame: at 12 months ]
- Effect on admissions in institutions (nursing homes or senior residential care) [ Time Frame: at 12 months ]
- Time before management of stroke and the length of stay in rehabilitation unit [ Time Frame: at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697553
|Contact: Thierry DANTOINE, MDemail@example.com|
|Contact: Achille TCHALLA, MDfirstname.lastname@example.org|
|CH Aubusson||Not yet recruiting|
|CH Bourganeuf||Not yet recruiting|
|CH de Gueret||Not yet recruiting|
|Contact: Thierry DANTOINE, MD|
|Sub-Investigator: COLLINS, MD|
|Study Chair:||Thierry DANTOINE, MD||CHU Limoges|