Disablement in the ElderlyDOMOLIMNCT01697553
Home-Based Technologies Coupled to Teleassistance Service in the Elderly
A study testing home automation pack coupled to teleassistance service and Home without automation pack coupled to teleassistance service in people with Disablement in the Elderly, run by University Hospital, Limoges at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Disablement in the Elderly
- What is being tested?
- home automation pack coupled to teleassistance service and Home without automation pack coupled to teleassistance service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2012to 17 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CH Aubusson
Aubusson
CH Bourganeuf
Bourganeuf
CH de Gueret
Guéret
CHU Limoges
Limoges
About this study
Official title: 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.
Read more
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
Read the 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:
- 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.
- Conditions
- Disablement in the Elderly
- Being tested
- home automation pack coupled to teleassistance service, Home without automation pack coupled to teleassistance service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home automation pack coupled to teleassistance serviceOther
Home without automation pack coupled to teleassistance serviceOther
| Study group | Role | What they receive |
|---|---|---|
| Home automation pack coupled to teleassistance service | Experimental | Not described Receives: Other: home automation pack coupled to teleassistance service |
| Home without automation pack coupled to teleassistance service | Active comparator | Not described Receives: Other: Home without automation pack coupled to teleassistance service |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of home falls requiring emergency admission
The cumulated incidence of home falls requiring emergency admission.
Measured: at 12 months
Secondary outcomes (4)
Changes score ISO profile resource according to SMAF scale
Measured: at 12 months
Proportion of participants with regular physical activity
Measured: at 12 months
Effect on admissions in institutions (nursing homes or senior residential care)
Measured: at 12 months
Time before management of stroke and the length of stay in rehabilitation unit
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion26 Oct 2015
- Study completion17 Jun 2016
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disablement in the ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry DANTOINE, MD, Study chair, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697553
- Sponsor's protocol ID
- I11 001
- Acronym
- DOMOLIM
- Status last verified
- Apr 2015
- First submitted
- 28 Sep 2012
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Technologies Coupled to Teleassistance Service: Efficacy for Preventing Falls at Home in Frail Elderly Population Losing Autonomy
- ClinicalTrials.gov ID
- NCT01697553
- Acronym / sponsor ID
- DOMOLIM / I11 001
- Conditions
- Disablement in the Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 26 Oct 2015 (actual)
- Study completion
- 17 Jun 2016 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home automation pack coupled to teleassistance service | Experimental | Other: home automation pack coupled to teleassistance service |
| Home without automation pack coupled to teleassistance service | Active comparator | Other: Home without automation pack coupled to teleassistance service |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home automation pack coupled to teleassistance service | Other | Home automation pack coupled to teleassistance service |
| Home without automation pack coupled to teleassistance service | Other | Home without automation pack coupled to teleassistance service |
Primary outcome
incidence of home falls requiring emergency admission
Time frame: at 12 months
The cumulated incidence of home falls requiring emergency admission.
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry DANTOINE, MD study chair
CHU Limoges
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home automation pack coupled to teleassistance service and Home without automation pack coupled to teleassistance service in people with Disablement in the Elderly, run by University Hospital, Limoges at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of home falls requiring emergency admission (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.