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Seniors Guardian: A Monitoring Platform for the Elderly

Seniors Guardian: A Non-intrusive Monitoring Platform for Activities of Daily Living Amongst the Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03891771
Acronym
SEMONE
Enrollment
69
Registered
2019-03-27
Start date
2019-04-30
Completion date
2021-06-06
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Elderly, Activities of daily living, Telemonitoring

Brief summary

This pilot study evaluates whether a telemonitoring platform of activities of daily living amongst the elderly can improve their quality of life. Participants will be randomised to two different follow-up strategies, one comprising a monitoring platform and the other standard visits at a healthcare facility. Quality of life will be assessed using standardised questionnaires.

Detailed description

Elderly participants at perceived socioeconomic risk will be randomised in a 1:1 ratio to receive either a telemonitoring platform in their houses or standard health care. The platform will include sensors able to detect falls, nocturia (which have been previously validated) and sensors for environmental variables including humidity, carbon monoxide levels and temperature. In addition, a wearable panic button will be provided for participants allocated to the sensor platform which will allow them to obtain help in case of an emergency. The sensor platform will be connected to emergency services and healthcare providers,and they should receive and react to any anomaly detected in their readings. Participants will be followed up for 10 months. Quality of life questionnaires, including the World Health Organisation's WHOQOL-BREF and the EQ-5D for health-related quality of life, will be used to address potential intervention effects.

Interventions

DEVICETelemonitoring sensors

This complex platform entails several sensors aimed at detecting falls, nocturia and environmental variables in the participant's home. Sensors are non-intrusive and its only wearable component is the panic button which must be carried by the participant.

Sponsors

Servicio de Vivienda y Urbanismo, Chile
CollaboratorUNKNOWN
Ilustre Municipalidad de San Antonio, Chile
CollaboratorUNKNOWN
Corporación Municipal de Valparaíso, Chile
CollaboratorUNKNOWN
Universidad de Valparaiso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elderly participant (\>65 years of age) perceived to be at socioeconomic risk * Resident in the city of Valparaiso or San Antonio * Lives alone * Obtained a housing subsidy from the Servicio de Vivienda y Urbanismo (Housing and Urbanism Services)

Exclusion criteria

* Dementia * Substance or alcohol abuse * Inability to answer quality of life questionnaires due to medical or psychiatric morbidity * Terminal illness (life expectancy under 6 months) * Ownership of pets within the residence (ie. dogs, cats). * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)1 month after randomisationThis scale is designed to assess the overall quality of life of the respondent using 5-point Likert scales. Higher scores mean a better quality of life. WHOQOL-BREF is divided in 4 domains, including physical health, psychological, social relationships and environment. The mean score for each domain is used to calculate the domain score. Scores can then be added together to obtain an overall score. Therefore, scores in the WHOQOL-BREF questionnaire range from 4 to 20 points.
Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire1 month after randomisationEuroQol-5D (EQ-5D) is a standardised questionnaire that allows to quantify health-related quality of life. It is divided in two sections, a descriptive section and a visual analogue scale (VAS) at the end of the questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale. Results are presented as a descriptive profile or as an index value calculated from the descriptive component which is country-specific. Visual analog values can range from 0 to 100, with higher values indicating an overall better health-related quality of life.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026