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

Frailty Clinical Trial

Official title: Health Monitoring and sOcial Integration environMEnt for Supporting WidE ExTension of Independent Life at HOME (HOMESWEETHOME)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Frailty

• NCT number: NCT01218373
• Study type: Interventional
• Source: Him SA
• Status: Completed
• Phase: N/A
• Start date: December 1, 2010
• Completion date: July 1, 2013