Clinical trial NCT01218373: The Clinical Evaluation of Continuous Assistance Offered to Older People Living Independently.
Official title: Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: older people
living independently at home
Lead sponsor: Him SA
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Netwerk Antwerpen (ZNA)
name: EuroCross
name: Badalona Serveis Assistencials
name: Department of Health, Generalitat de Catalunya
name: Louth County Council
name: Health Services Executive North Eastern Area
name: TeleMedicina Rizzoli
name: Darco Servizi
name: Azienda USL di Latina
name: University of Roma La Sapienza
First posted: 2010-10-11
Enrollment: 2010
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: measurement will be at trial start (t=0 months)
measure: Quality of life (QoL)
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Quality of life (QoL)
timeFrame: measurement will be at trial end (t=30 months)
Secondary outcomes:
measure: Nursing home admission
timeFrame: measurement will be at trial start (t=0months)
measure: Mortality
timeFrame: continous monitoring during trial duration = 30 months.
measure: Frailty
timeFrame: measurement will be at trial start (t=0 months)
measure: Geriatric assessment
timeFrame: measurement will be at trial start (t=0 months)
measure: Clinical Global Impression
timeFrame: measurement will be at trial start (t=0 months)
measure: Depression and anxiety
timeFrame: measurement will be at trial start (t=0 months)
measure: Nursing home admission
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Nursing home admission
timeFrame: measurement will be at trial end (t=30 months).
measure: Frailty
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Frailty
timeFrame: measurement will be at trial end (t=30 months)
measure: Geriatric assessment
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Geriatric assessment
timeFrame: measurement will be at trial end (t=30 months)
measure: Depression and anxiety
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Depression and anxiety
timeFrame: measurement will be at trial end (t=30 months)
measure: Clinical Global Impression
timeFrame: measurement will be at trial midterm (t=15 months)
measure: Clinical Global Impression
timeFrame: measurement will be at trial end (t=30 months)
measure: Number of hospitalisations
timeFrame: measurement will be at trial start (t=0 months)
measure: Number of hospitalizations
timeFrame: measurement will be at trial midterm (t=15 months).
measure: Number of hospitalisations
timeFrame: measurement will be at trial end (t=30 months)
measure: Number of accesses to emergency rooms
timeFrame: measurement will be at trial start (t=0 months)
measure: Number of accesses to emergency rooms
timeFrame: measurement will be at trial midterm (t=15 months).
measure: Number of accesses to emergency rooms
timeFrame: measurement will be at trial end (t=30 months)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA
state: Vlaanderen
city: Dublin
country: Ireland
facility: Netwell Centre
city: Latina
country: Italy
facility: Viale P.L. Nervi, Centro Commerciale Latinafiori, Torre Girasoli, 4100 Latina
state: Lazio Regon
city: Badalona
country: Spain
facility: Badalona Serveis Assistencials
state: Catalunya
Study officials:
affiliation: Him SA
name: Wouter A Keijser, MD
role: STUDY_DIRECTOR
References: