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

NCT ID: NCT01218373

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2010 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-01
• Study Completion Date: 2013-07-01

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.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group: HOMESWEETHOME services

Monitoring and alarm handling services. eInclusion services. Domotica services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.

Group Type: ACTIVE_COMPARATOR

HOMESWEETHOME Services

Intervention Type: DEVICE

Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.

Control Group: No HOMESWEETHOME services

Normal care.

Group Type: PLACEBO_COMPARATOR

No HOMESWEETHOME services installed

Intervention Type: DEVICE

Normal care and healthcare without HOMESWEETHOME services.

Interventions

HOMESWEETHOME Services

Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.

Intervention Type: DEVICE

No HOMESWEETHOME services installed

Normal care and healthcare without HOMESWEETHOME services.

Intervention Type: DEVICE

Other Intervention Names

e.g. DREAMING project devices.; no applicable

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziekenhuis Netwerk Antwerpen (ZNA)

OTHER

Sponsor Role: collaborator

EuroCross

UNKNOWN

Sponsor Role: collaborator

Badalona Serveis Assistencials

OTHER

Sponsor Role: collaborator

Department of Health, Generalitat de Catalunya

OTHER_GOV

Sponsor Role: collaborator

Louth County Council

UNKNOWN

Sponsor Role: collaborator

Health Services Executive North Eastern Area

UNKNOWN

Sponsor Role: collaborator

TeleMedicina Rizzoli

UNKNOWN

Sponsor Role: collaborator

Darco Servizi

UNKNOWN

Sponsor Role: collaborator

Azienda USL di Latina

UNKNOWN

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

Him SA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wouter A Keijser, MD

Role: STUDY_DIRECTOR

Him SA

Locations

ZNA

Antwerp, Flanders, Belgium

Netwell Centre

Dublin, , Ireland

Viale P.L. Nervi, Centro Commerciale Latinafiori, Torre Girasoli, 4100 Latina

Latina, Lazio Regon, Italy

Badalona Serveis Assistencials

Badalona, Catalonia, Spain

Countries

Belgium; Ireland; Italy; Spain

Other Identifiers

250449

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSH-CLTRPR-01

Identifier Type: -

Identifier Source: org_study_id