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

Study Overview
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Brief Summary
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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 peoples homes, there is a significant positive effect on the quality of life (QoL) and the duration of independently living of older people.

Detailed Description
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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 peoples 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.

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

Conditions
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Frailty

Intervention / Treatment
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* Device: HOMESWEETHOME Services
* Device: No HOMESWEETHOME services installed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group: HOMESWEETHOME services<br>Monitoring and alarm handling services. eInclusion services. Domotica services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services. | Device: HOMESWEETHOME Services<br>* Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.<br>* Other names: e.g. DREAMING project devices.;|
| Placebo Comparator: Control Group: No HOMESWEETHOME services<br>Normal care. | Device: No HOMESWEETHOME services installed<br>* Normal care and healthcare without HOMESWEETHOME services.<br>* Other names: no applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nursing home admission | Nursing home admission as assessed from records/equivalent sources | measurement will be at trial start (t=0months) | 
| Mortality | deceasing of participant | continous monitoring during trial duration = 30 months. | 
| Frailty | Frailty as assessed with Edmonton Frailty Scale (EFS) | measurement will be at trial start (t=0 months) | 
| Geriatric assessment | as assesses with Comprehensive Geriatric Assessment (CGA) | measurement will be at trial start (t=0 months) | 
| Clinical Global Impression | as assessed with Clinical Global Impression (CGI) | measurement will be at trial start (t=0 months) | 
| Depression and anxiety | as assessed with Hospital Anxiety and Depression Scale (HADS). | measurement will be at trial start (t=0 months) | 
| Nursing home admission | Nursing home admission as assessed from records/equivalent sources | measurement will be at trial midterm (t=15 months) | 
| Nursing home admission | Nursing home admission as assessed from records/equivalent sources | measurement will be at trial end (t=30 months). | 
| Frailty | Frailty as assessed with Edmonton Frailty Scale (EFS) | measurement will be at trial midterm (t=15 months) | 
| Frailty | Frailty as assessed with Edmonton Frailty Scale (EFS) | measurement will be at trial end (t=30 months) | 
| Geriatric assessment | as assesses with Comprehensive Geriatric Assessment (CGA) | measurement will be at trial midterm (t=15 months) | 
| Geriatric assessment | as assesses with Comprehensive Geriatric Assessment (CGA) | measurement will be at trial end (t=30 months) | 
| Depression and anxiety | as assessed with Hospital Anxiety and Depression Scale (HADS). | measurement will be at trial midterm (t=15 months) | 
| Depression and anxiety | as assessed with Hospital Anxiety and Depression Scale (HADS). | measurement will be at trial end (t=30 months) | 
| Clinical Global Impression | as assessed with Clinical Global Impression (CGI) | measurement will be at trial midterm (t=15 months) | 
| Clinical Global Impression | as assessed with Clinical Global Impression (CGI) | measurement will be at trial end (t=30 months) | 
| Number of hospitalisations |  | measurement will be at trial start (t=0 months) | 
| Number of hospitalizations |  | measurement will be at trial midterm (t=15 months). | 
| Number of hospitalisations |  | measurement will be at trial end (t=30 months) | 
| Number of accesses to emergency rooms |  | measurement will be at trial start (t=0 months) | 
| Number of accesses to emergency rooms |  | measurement will be at trial midterm (t=15 months). | 
| Number of accesses to emergency rooms |  | measurement will be at trial end (t=30 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older people, living independently at home