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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Him SA.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Ziekenhuis Netwerk Antwerpen (ZNA)
EuroCross
Badalona Serveis Assistencials
Departament de Salut de la Generalitat de Catalunya - Ticsalut
Louth County Council
Health Services Executive North Eastern Area
TeleMedicina Rizzoli
Darco Servizi
Azienda USL di Latina
University of Roma La Sapienza
Information provided by:
Him SA
ClinicalTrials.gov Identifier:
NCT01218373
First received: October 5, 2010
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Frailty
Device: HOMESWEETHOME Services
Device: No HOMESWEETHOME services installed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)

Resource links provided by NLM:


Further study details as provided by Him SA:

Primary Outcome Measures:
  • Quality of life (QoL) [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
    Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).

  • Quality of life (QoL) [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).

  • Quality of life (QoL) [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
    Health related QoL as measured with Health Status Questionnaire Short Form 36 (SF-36) (v2).


Secondary Outcome Measures:
  • Nursing home admission [ Time Frame: measurement will be at trial start (t=0months) ] [ Designated as safety issue: No ]
    Nursing home admission as assessed from records/equivalent sources

  • Mortality [ Time Frame: continous monitoring during trial duration = 30 months. ] [ Designated as safety issue: No ]
    deceasing of participant

  • Frailty [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
    Frailty as asessed with Edmonton Frailty Scale (EFS)

  • Geriatric assessment [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
    as assesses with Comprehensive Geriatric Assessment (CGA)

  • Clinical Global Impression [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
    as assessed with Clinical Global Impression (CGI)

  • Depression and anxiety [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
    as assessed with Hospital Anxiety and Depression Scale (HADS).

  • Nursing home admission [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    Nursing home admission as assessed from records/equivalent sources

  • Nursing home admission [ Time Frame: measurement will be at trial end (t=30 months). ] [ Designated as safety issue: No ]
    Nursing home admission as assessed from records/equivalent sources

  • Frailty [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    Frailty as asessed with Edmonton Frailty Scale (EFS)

  • Frailty [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
    Frailty as asessed with Edmonton Frailty Scale (EFS)

  • Geriatric assessment [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    as assesses with Comprehensive Geriatric Assessment (CGA)

  • Geriatric assessment [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
    as assesses with Comprehensive Geriatric Assessment (CGA)

  • Depression and anxiety [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    as assessed with Hospital Anxiety and Depression Scale (HADS).

  • Depression and anxiety [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
    as assessed with Hospital Anxiety and Depression Scale (HADS).

  • Clinical Global Impression [ Time Frame: measurement will be at trial midterm (t=15 months) ] [ Designated as safety issue: No ]
    as assessed with Clinical Global Impression (CGI)

  • Clinical Global Impression [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
    as assessed with Clinical Global Impression (CGI)

  • Number of hospitalisations [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
  • Number of hospitalizations [ Time Frame: measurement will be at trial midterm (t=15 months). ] [ Designated as safety issue: No ]
  • Number of hospitalisations [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]
  • Number of accesses to emergency rooms [ Time Frame: measurement will be at trial start (t=0 months) ] [ Designated as safety issue: No ]
  • Number of accesses to emergency rooms [ Time Frame: measurement will be at trial midterm (t=15 months). ] [ Designated as safety issue: No ]
  • Number of accesses to emergency rooms [ Time Frame: measurement will be at trial end (t=30 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2010
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention Group: HOMESWEETHOME services
Monitoring and alarm handling services. eInclusion services. Domotica services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.
Device: HOMESWEETHOME Services
Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.
Other Name: e.g. DREAMING project devices.
Placebo Comparator: Control Group: No HOMESWEETHOME services
Normal care.
Device: No HOMESWEETHOME services installed
Normal care and healthcare without HOMESWEETHOME services.
Other Name: no applicable

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218373

Contacts
Contact: Wouter A Keijser, MD +31628541565 wouter.keijser@wacomed.nl

Locations
Belgium
ZNA Not yet recruiting
Antwerp, Vlaanderen, Belgium
Contact: Maurits vandeWoude, MD PhD    +32 3 234 42 49    Maurits.Vandewoude@zna.be   
Principal Investigator: Maurits vandeWoude, MD         
Ireland
Netwell Centre Not yet recruiting
Dublin, Ireland
Contact: Rodd Bond, MD    +353 (0) 86 383 5553    rodd.bond@netwellcentre.org   
Principal Investigator: Rodd Bond, MD         
Italy
Viale P.L. Nervi, Centro Commerciale Latinafiori, Torre Girasoli, 4100 Latina Not yet recruiting
Latina, Lazio Regon, Italy, 04100
Contact: Luigi Ardia, MD    0773/8842030    luigiardia@libero.it   
Principal Investigator: Luigi Ardia, MD         
Spain
Badalona Serveis Assistencials Not yet recruiting
Badalona, Catalunya, Spain, 08911
Contact: Ignasi S Aguayo, MD    +34 93 5074710    isaez@bsa.cat   
Principal Investigator: Ignasi S Aguayo, MD         
Sponsors and Collaborators
Him SA
Ziekenhuis Netwerk Antwerpen (ZNA)
EuroCross
Badalona Serveis Assistencials
Departament de Salut de la Generalitat de Catalunya - Ticsalut
Louth County Council
Health Services Executive North Eastern Area
TeleMedicina Rizzoli
Darco Servizi
Azienda USL di Latina
University of Roma La Sapienza
Investigators
Study Director: Wouter A Keijser, MD Him SA
  More Information

Additional Information:
No publications provided

Responsible Party: HIM, European Comission
ClinicalTrials.gov Identifier: NCT01218373     History of Changes
Other Study ID Numbers: HSH-CLTRPR-01, 250449
Study First Received: October 5, 2010
Last Updated: October 11, 2010
Health Authority: Belgium: Ethics Committee
Spain: Ethics Committee
Ireland: Ministry of Health
Italy: Ministry of Health

Keywords provided by Him SA:
older people
living independently at home

ClinicalTrials.gov processed this record on September 14, 2014