The Clinical Evaluation of Continuous Assistance Offered to Older People Living Independently.

Frailty Clinical Trial

— HOMESWEETHOME  

Official title:

Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218373
• Other study ID #: HSH-CLTRPR-01
• Secondary ID: 250449
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: January 24, 2017
• Start date: December 1, 2010
• Est. completion date: July 1, 2013

Study information

• Verified date: January 2017
• Source: Him SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2010
• Est. completion date: July 1, 2013
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Frailty

Intervention

Device:
• HOMESWEETHOME Services
Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.
• No HOMESWEETHOME services installed
Normal care and healthcare without HOMESWEETHOME services.

Locations

Country	Name	City	State
Belgium	ZNA	Antwerp	Vlaanderen
Ireland	Netwell Centre	Dublin
Italy	Viale P.L. Nervi, Centro Commerciale Latinafiori, Torre Girasoli, 4100 Latina	Latina	Lazio Regon
Spain	Badalona Serveis Assistencials	Badalona	Catalunya

Sponsors (11)

Lead Sponsor	Collaborator
Him SA	Azienda USL di Latina, Badalona Serveis Assistencials, Darco Servizi, Department of Health, Generalitat de Catalunya, EuroCross, Health Services Executive North Eastern Area, Louth County Council, TeleMedicina Rizzoli, University of Roma La Sapienza, Ziekenhuis Netwerk Antwerpen (ZNA)

Countries where clinical trial is conducted

Belgium,  Ireland,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QoL)	Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).	measurement will be at trial start (t=0 months)
Primary	Quality of life (QoL)	Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).	measurement will be at trial midterm (t=15 months)
Primary	Quality of life (QoL)	Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).	measurement will be at trial end (t=30 months)
Secondary	Nursing home admission	Nursing home admission as assessed from records/equivalent sources	measurement will be at trial start (t=0months)
Secondary	Mortality	deceasing of participant	continous monitoring during trial duration = 30 months.
Secondary	Frailty	Frailty as assessed with Edmonton Frailty Scale (EFS)	measurement will be at trial start (t=0 months)
Secondary	Geriatric assessment	as assesses with Comprehensive Geriatric Assessment (CGA)	measurement will be at trial start (t=0 months)
Secondary	Clinical Global Impression	as assessed with Clinical Global Impression (CGI)	measurement will be at trial start (t=0 months)
Secondary	Depression and anxiety	as assessed with Hospital Anxiety and Depression Scale (HADS).	measurement will be at trial start (t=0 months)
Secondary	Nursing home admission	Nursing home admission as assessed from records/equivalent sources	measurement will be at trial midterm (t=15 months)
Secondary	Nursing home admission	Nursing home admission as assessed from records/equivalent sources	measurement will be at trial end (t=30 months).
Secondary	Frailty	Frailty as assessed with Edmonton Frailty Scale (EFS)	measurement will be at trial midterm (t=15 months)
Secondary	Frailty	Frailty as assessed with Edmonton Frailty Scale (EFS)	measurement will be at trial end (t=30 months)
Secondary	Geriatric assessment	as assesses with Comprehensive Geriatric Assessment (CGA)	measurement will be at trial midterm (t=15 months)
Secondary	Geriatric assessment	as assesses with Comprehensive Geriatric Assessment (CGA)	measurement will be at trial end (t=30 months)
Secondary	Depression and anxiety	as assessed with Hospital Anxiety and Depression Scale (HADS).	measurement will be at trial midterm (t=15 months)
Secondary	Depression and anxiety	as assessed with Hospital Anxiety and Depression Scale (HADS).	measurement will be at trial end (t=30 months)
Secondary	Clinical Global Impression	as assessed with Clinical Global Impression (CGI)	measurement will be at trial midterm (t=15 months)
Secondary	Clinical Global Impression	as assessed with Clinical Global Impression (CGI)	measurement will be at trial end (t=30 months)
Secondary	Number of hospitalisations		measurement will be at trial start (t=0 months)
Secondary	Number of hospitalizations		measurement will be at trial midterm (t=15 months).
Secondary	Number of hospitalisations		measurement will be at trial end (t=30 months)
Secondary	Number of accesses to emergency rooms		measurement will be at trial start (t=0 months)
Secondary	Number of accesses to emergency rooms		measurement will be at trial midterm (t=15 months).
Secondary	Number of accesses to emergency rooms		measurement will be at trial end (t=30 months)

External Links

•   project website