Status:

COMPLETED

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

Lead Sponsor:

Him SA

Collaborating Sponsors:

Ziekenhuis Netwerk Antwerpen (ZNA)

EuroCross

Conditions:

Frailty

Eligibility:

All Genders

65+ years

Phase:

NA

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 t...

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 - Consolid...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2013

Estimated Enrollment :

2010 Patients enrolled

Trial Details

Trial ID

NCT01218373

Start Date

December 1 2010

End Date

July 1 2013

Last Update

January 25 2017

Active Locations (4)

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Page 1 of 1 (4 locations)

1

ZNA

Antwerp, Flanders, Belgium

2

Netwell Centre

Dublin, Ireland

3

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

Latina, Lazio Regon, Italy, 04100

4

Badalona Serveis Assistencials

Badalona, Catalonia, Spain, 08911