Home-Based Technologies Coupled to Teleassistance Service in the Elderly (DOMOLIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01697553
First received: September 28, 2012
Last updated: March 22, 2014
Last verified: March 2014
  Purpose

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 Intervention
Disablement in the Elderly
Other: home automation pack coupled to teleassistance service
Other: Home without automation pack coupled to teleassistance service

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • incidence of home falls requiring emergency admission [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
    The cumulated incidence of home falls requiring emergency admission.


Secondary Outcome Measures:
  • Changes score ISO profile resource according to SMAF scale [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Proportion of participants with regular physical activity [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Effect on admissions in institutions (nursing homes or senior residential care) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Time before management of stroke and the length of stay in rehabilitation unit [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

Primary outcome:

The main judgment criterion will be the cumulated incidence of home falls requiring emergency admission.

Secondary outcomes:

  1. Changes score ISO profile resource according to SMAF scale,
  2. Proportion of participants with regular physical activity
  3. Effect on admissions in institutions (nursing homes or senior residential care)
  4. Time before management of stroke and the length of stay in rehabilitation unit.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 65 or over
  • Living at least for 1 year in the department of Creuse
  • Frail elderly or pre-frail according to the criteria of Fried
  • Patient with autonomy enough to get out of bed
  • Having a cognitive level acceptable (MMS ≥ 10)
  • Place of life arranged and adapted to the installation of the DSTA
  • Consentbsigned by the patient and / or its trusted person or his legal representative
  • Affiliation or beneficiary of a social security system

Exclusion Criteria:

  • Patient under guardianship or protection of justice
  • patient home already equiped with automation pack different from theone of the experiment
  • People who can not read or write
  • Diseases involving life-threatening in the short term (<1 year)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697553

Contacts
Contact: Thierry DANTOINE, MD 0555058621 thierry.dantoine@unilim.fr
Contact: Achille TCHALLA, MD 055556957 achille.tchalla@unilim.fr

Locations
France
CH Aubusson Not yet recruiting
Aubusson, France
CH Bourganeuf Not yet recruiting
Bourganeuf, France
CH de Gueret Not yet recruiting
Gueret, France
CHU Limoges Recruiting
Limoges, France
Contact: Thierry DANTOINE, MD         
Sub-Investigator: COLLINS, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Study Chair: Thierry DANTOINE, MD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01697553     History of Changes
Other Study ID Numbers: I11 001
Study First Received: September 28, 2012
Last Updated: March 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 25, 2014