FrailtyHOMESWEETHOMENCT01218373
The Clinical Evaluation of Continuous Assistance Offered to Older People Living Independently.
A study testing HOMESWEETHOME Services and No HOMESWEETHOME services installed in people with Frailty, run by Him SA at 4 sites in 4 countries.
Trial summary
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- HOMESWEETHOME Services and No HOMESWEETHOME services installed
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,010 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Dec 2010to 1 Jul 2013
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or over.
- Living at home or in the community, i.e. not in a nursing home, acute or sub-acute clinical or care setting.
- Scoring "mildly frail" or "moderately frail" in Edmonton Frail Scale (EFS).
Who cannot join
- Not willing to participate (e.g. no signing informed consent form).
- Living situation not suitable for independent living (also including long planned durations of absence from home).
- Physically, mentally or otherwise unable to use and / or operate HOMESWEETHOME devices / instruments.
- Unable to administer self-assessment measurements (e.g. monitoring vital signs; questionnaires).
- Significant impairment of language comprehension or expression (e.g. aphasia).
- Active medical illness with a significant shortened life expectancy (< 6 months), based on mortality prognosis2.
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- Living without access to ISDN or ADSL service.
- Living with another HOMESWEETHOME participant in the same home.
- Completely dependent on others for the activities of daily living.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Italy1 site
Viale P.L. Nervi, Centro Commerciale Latinafiori, Torre Girasoli, 4100 Latina
Latina, Lazio Regon, 04100
About this study
Official title: Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
Read the detailed description
The HOMESWEETHOME clinical trial is conducted as a multi-centre randomised control trial (RCT), across four pilot sites. The trial design, analysis and reporting follow the "Revised CONSORT - Consolidated Standards of Reporting Trials - Statement" and subsequent additions to the CONSORT statement.
HOMESWEETHOME services are expected to result in an outcome that is superior to usual care alone in reducing deterioration of health related quality of life and function associated with age and chronic disease. This effect will be measured by assessing different outcomes.
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
The study is conducted in four sites within the European Union, these sites will have the number of participants randomised into Intervention Group and Control Group, as follows:
- Belgium - City of Antwerp 30 + 30
- Catalonia - Town of Badalona 15 + 15
- Ireland - North Eastern Region 30 + 30
- Italy - Town of Latina 30 + 30 The main inclusion criteria for participants" entry into the trial will be based on frailty. Frailty is a concept associated with adverse outcomes such as higher morbidity, more hospitalisations and falls, and a lower quality of life. Furthermore, frailty predicts - better than age - the evolution to disability and death. Participants must also be 65 years or over, and living at home. The main reasons for excluding participants will be based on their physical or mental (in)ability to take part.
The primary clinical outcome for the trials will be measured based on the Health Status Questionnaire Short Form 36 (SF-36) (v2).
Secondary outcomes will be measured using Edmonton Frailty Scale (EFS), Comprehensive Geriatric Assessment (CGA), Clinical Global Impression (CGI), and Hospital Anxiety and Depression Scale (HADS). A number of medical events will also be measured.
Measurements will be taken at trial start, trial mid-term, and trial end. Measurements will be entered, anonymously, into a database for analysis of results. The trial population size has been subjected to a statistical power analysis, to ensure statistical significance of project results.
- Conditions
- Frailty
- Being tested
- HOMESWEETHOME Services, No HOMESWEETHOME services installed
- Keywords
- older people, living independently at home
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMESWEETHOME ServicesDevice
Also called e.g. DREAMING project devices.
Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.
No HOMESWEETHOME services installedDevice
Also called no applicable
Normal care and healthcare without HOMESWEETHOME services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: HOMESWEETHOME services | Active comparator | Monitoring and alarm handling services. eInclusion services. Domotica services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services. Receives: Device: HOMESWEETHOME Services |
| Control Group: No HOMESWEETHOME services | Placebo comparator | Normal care. Receives: Device: No HOMESWEETHOME services installed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QoL)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
Measured: measurement will be at trial start (t=0 months)
Quality of life (QoL)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
Measured: measurement will be at trial midterm (t=15 months)
Quality of life (QoL)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
Measured: measurement will be at trial end (t=30 months)
Secondary outcomes (22)
Nursing home admission
Nursing home admission as assessed from records/equivalent sources
Measured: measurement will be at trial start (t=0months)
Mortality
deceasing of participant
Measured: continous monitoring during trial duration = 30 months.
Frailty
Frailty as assessed with Edmonton Frailty Scale (EFS)
Measured: measurement will be at trial start (t=0 months)
Geriatric assessment
as assesses with Comprehensive Geriatric Assessment (CGA)
Measured: measurement will be at trial start (t=0 months)
Clinical Global Impression
as assessed with Clinical Global Impression (CGI)
Measured: measurement will be at trial start (t=0 months)
Depression and anxiety
as assessed with Hospital Anxiety and Depression Scale (HADS).
Measured: measurement will be at trial start (t=0 months)
Nursing home admission
Nursing home admission as assessed from records/equivalent sources
Measured: measurement will be at trial midterm (t=15 months)
Nursing home admission
Nursing home admission as assessed from records/equivalent sources
Measured: measurement will be at trial end (t=30 months).
Frailty
Frailty as assessed with Edmonton Frailty Scale (EFS)
Measured: measurement will be at trial midterm (t=15 months)
Frailty
Frailty as assessed with Edmonton Frailty Scale (EFS)
Measured: measurement will be at trial end (t=30 months)
Geriatric assessment
as assesses with Comprehensive Geriatric Assessment (CGA)
Measured: measurement will be at trial midterm (t=15 months)
Geriatric assessment
as assesses with Comprehensive Geriatric Assessment (CGA)
Measured: measurement will be at trial end (t=30 months)
Depression and anxiety
as assessed with Hospital Anxiety and Depression Scale (HADS).
Measured: measurement will be at trial midterm (t=15 months)
Depression and anxiety
as assessed with Hospital Anxiety and Depression Scale (HADS).
Measured: measurement will be at trial end (t=30 months)
Clinical Global Impression
as assessed with Clinical Global Impression (CGI)
Measured: measurement will be at trial midterm (t=15 months)
Clinical Global Impression
as assessed with Clinical Global Impression (CGI)
Measured: measurement will be at trial end (t=30 months)
Number of hospitalisations
Measured: measurement will be at trial start (t=0 months)
Number of hospitalizations
Measured: measurement will be at trial midterm (t=15 months).
Number of hospitalisations
Measured: measurement will be at trial end (t=30 months)
Number of accesses to emergency rooms
Measured: measurement will be at trial start (t=0 months)
Number of accesses to emergency rooms
Measured: measurement will be at trial midterm (t=15 months).
Number of accesses to emergency rooms
Measured: measurement will be at trial end (t=30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study start1 Dec 2010
- Primary completion1 May 2013
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Him SA
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Netwerk Antwerpen (ZNA), EuroCross, Badalona Serveis Assistencials, Department of Health, Generalitat de Catalunya, Louth County Council, Health Services Executive North Eastern Area, TeleMedicina Rizzoli, Darco Servizi, Azienda USL di Latina, University of Roma La Sapienza
- Responsible party
- Sponsor
- Investigators
- Wouter A Keijser, MD, Study director, Him SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218373
- Sponsor's protocol ID
- HSH-CLTRPR-01
- Other IDs
- 250449
- Acronym
- HOMESWEETHOME
- Status last verified
- Jan 2017
- First submitted
- 5 Oct 2010
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)
- ClinicalTrials.gov ID
- NCT01218373
- Acronym / sponsor ID
- HOMESWEETHOME / HSH-CLTRPR-01
- Conditions
- Frailty
- Keywords
- older people, living independently at home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,010 participants (actual)
- Lead sponsor
- Him SAUniversity, hospital or other
- Collaborators
- Ziekenhuis Netwerk Antwerpen (ZNA), EuroCross, Badalona Serveis Assistencials, Department of Health, Generalitat de Catalunya, Louth County Council, Health Services Executive North Eastern Area, TeleMedicina Rizzoli, Darco Servizi, Azienda USL di Latina, University of Roma La Sapienza
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 11 Oct 2010 (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 clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
Detailed description
The HOMESWEETHOME clinical trial is conducted as a multi-centre randomised control trial (RCT), across four pilot sites. The trial design, analysis and reporting follow the "Revised CONSORT - Consolidated Standards of Reporting Trials - Statement" and subsequent additions to the CONSORT statement.
HOMESWEETHOME services are expected to result in an outcome that is superior to usual care alone in reducing deterioration of health related quality of life and function associated with age and chronic disease. This effect will be measured by assessing different outcomes.
The clinical evaluation of the HOMESWEETHOME project sets out to assess the long-term effects of continuous assistance offered by the HOMESWEETHOME services to older people living independently. The trial will test the hypothesis that while providing a level of safety equivalent to or better than that enjoyed in older people"s homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.
The study is conducted in four sites within the European Union, these sites will have the number of participants randomised into Intervention Group and Control Group, as follows:
- Belgium - City of Antwerp 30 + 30
- Catalonia - Town of Badalona 15 + 15
- Ireland - North Eastern Region 30 + 30
- Italy - Town of Latina 30 + 30 The main inclusion criteria for participants" entry into the trial will be based on frailty. Frailty is a concept associated with adverse outcomes such as higher morbidity, more hospitalisations and falls, and a lower quality of life. Furthermore, frailty predicts - better than age - the evolution to disability and death. Participants must also be 65 years or over, and living at home. The main reasons for excluding participants will be based on their physical or mental (in)ability to take part.
The primary clinical outcome for the trials will be measured based on the Health Status Questionnaire Short Form 36 (SF-36) (v2).
Secondary outcomes will be measured using Edmonton Frailty Scale (EFS), Comprehensive Geriatric Assessment (CGA), Clinical Global Impression (CGI), and Hospital Anxiety and Depression Scale (HADS). A number of medical events will also be measured.
Measurements will be taken at trial start, trial mid-term, and trial end. Measurements will be entered, anonymously, into a database for analysis of results. The trial population size has been subjected to a statistical power analysis, to ensure statistical significance of project results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: HOMESWEETHOME services | Active comparator | Device: HOMESWEETHOME ServicesMonitoring and alarm handling services. eInclusion services. Domotica services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services. |
| Control Group: No HOMESWEETHOME services | Placebo comparator | Device: No HOMESWEETHOME services installedNormal care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years or over.
- Living at home or in the community, i.e. not in a nursing home, acute or sub-acute clinical or care setting.
- Scoring "mildly frail" or "moderately frail" in Edmonton Frail Scale (EFS).
Key exclusion criteria (9 listed)
- Not willing to participate (e.g. no signing informed consent form).
- Living situation not suitable for independent living (also including long planned durations of absence from home).
- Physically, mentally or otherwise unable to use and / or operate HOMESWEETHOME devices / instruments.
- Unable to administer self-assessment measurements (e.g. monitoring vital signs; questionnaires).
- Significant impairment of language comprehension or expression (e.g. aphasia).
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 |
|---|---|---|
| HOMESWEETHOME ServicesAlso: e.g. DREAMING project devices.Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services. | Device | Intervention Group: HOMESWEETHOME services |
| No HOMESWEETHOME services installedAlso: no applicableNormal care and healthcare without HOMESWEETHOME services. | Device | Control Group: No HOMESWEETHOME services |
Primary outcome
Quality of life (QoL)
Time frame: measurement will be at trial start (t=0 months)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
Quality of life (QoL)
Time frame: measurement will be at trial midterm (t=15 months)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
Quality of life (QoL)
Time frame: measurement will be at trial end (t=30 months)
Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).
22 secondary outcomes
Nursing home admission
Time frame: measurement will be at trial start (t=0months)
Mortality
Time frame: continous monitoring during trial duration = 30 months.
Frailty
Time frame: measurement will be at trial start (t=0 months)
Geriatric assessment
Time frame: measurement will be at trial start (t=0 months)
Clinical Global Impression
Time frame: measurement will be at trial start (t=0 months)
Depression and anxiety
Time frame: measurement will be at trial start (t=0 months)
Nursing home admission
Time frame: measurement will be at trial midterm (t=15 months)
Nursing home admission
Time frame: measurement will be at trial end (t=30 months).
Frailty
Time frame: measurement will be at trial midterm (t=15 months)
Frailty
Time frame: measurement will be at trial end (t=30 months)
Geriatric assessment
Time frame: measurement will be at trial midterm (t=15 months)
Geriatric assessment
Time frame: measurement will be at trial end (t=30 months)
Depression and anxiety
Time frame: measurement will be at trial midterm (t=15 months)
Depression and anxiety
Time frame: measurement will be at trial end (t=30 months)
Clinical Global Impression
Time frame: measurement will be at trial midterm (t=15 months)
Clinical Global Impression
Time frame: measurement will be at trial end (t=30 months)
Number of hospitalisations
Time frame: measurement will be at trial start (t=0 months)
Number of hospitalizations
Time frame: measurement will be at trial midterm (t=15 months).
Number of hospitalisations
Time frame: measurement will be at trial end (t=30 months)
Number of accesses to emergency rooms
Time frame: measurement will be at trial start (t=0 months)
Number of accesses to emergency rooms
Time frame: measurement will be at trial midterm (t=15 months).
Number of accesses to emergency rooms
Time frame: measurement will be at trial end (t=30 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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.
Wouter A Keijser, MD study director
Him SA
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOMESWEETHOME Services and No HOMESWEETHOME services installed in people with Frailty, run by Him SA at 4 sites in 4 countries.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 25 Jan 2017. 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 Belgium, Ireland, Italy, Spain. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life (QoL) (time frame: measurement will be at trial start (t=0 months)). The study lists 3 primary outcomes in all. 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 25 Jan 2017.