NCT01218373

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,010

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

October 5, 2010

Last Update Submit

January 24, 2017

Conditions

Frailty

Keywords

older peopleliving independently at home

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (22)

  • Nursing home admission

    measurement will be at trial start (t=0months)

  • Mortality

    continous monitoring during trial duration = 30 months.

  • Frailty

    measurement will be at trial start (t=0 months)

  • Geriatric assessment

    measurement will be at trial start (t=0 months)

  • Clinical Global Impression

    measurement will be at trial start (t=0 months)

  • +17 more secondary outcomes

Study Arms (2)

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.

Device: HOMESWEETHOME Services

Control Group: No HOMESWEETHOME services

PLACEBO COMPARATOR

Normal care.

Device: No HOMESWEETHOME services installed

Interventions

HOMESWEETHOME ServicesDEVICE

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

Also known as: e.g. DREAMING project devices.
Intervention Group: HOMESWEETHOME services
No HOMESWEETHOME services installedDEVICE

Normal care and healthcare without HOMESWEETHOME services.

Also known as: no applicable
Control Group: No HOMESWEETHOME services

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ZNA

Antwerp, Flanders, Belgium

Location

Netwell Centre

Dublin, Ireland

Location

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

Latina, Lazio Regon, 04100, Italy

Location

Badalona Serveis Assistencials

Badalona, Catalonia, 08911, Spain

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wouter A Keijser, MD

    Him SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 11, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

BE(1)ES(1)IE(1)IT(1)