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

April 1, 2015 updated by: University Hospital, Limoges

Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aubusson, France
        • Not yet recruiting
        • CH Aubusson
      • Bourganeuf, France
        • Not yet recruiting
        • CH Bourganeuf
      • Gueret, France
        • Not yet recruiting
        • CH de Gueret
      • Limoges, France
        • Recruiting
        • CHU Limoges
        • Contact:
          • Thierry DANTOINE, MD
        • Sub-Investigator:
          • COLLINS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of home falls requiring emergency admission
Time Frame: at 12 months
The cumulated incidence of home falls requiring emergency admission.
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes score ISO profile resource according to SMAF scale
Time Frame: at 12 months
at 12 months
Proportion of participants with regular physical activity
Time Frame: at 12 months
at 12 months
Effect on admissions in institutions (nursing homes or senior residential care)
Time Frame: at 12 months
at 12 months
Time before management of stroke and the length of stay in rehabilitation unit
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • I11 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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