Seniors Guardian: A Monitoring Platform for the Elderly

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Device: Telemonitoring sensors

• Registration Number: NCT03891771
• Lead Sponsor: Universidad de Valparaiso

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.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Study Start: 2019-04-30
• Primary Completion: 2021-06-06
• Study Completion: 2021-06-06
• Status Verified: 2021-10
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring sensors	Telemonitoring sensors	Patients allocated to this arm will receive a complex sensor platform aimed at detecting falls at home, nocturia and several environmental variables, including carbon monoxide concentrations, humidity and temperature. The system also includes a panic button that can be used to request assistance in emergencies.

Primary Outcome Measures

Name	Time	Method
Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	10 months after randomisation	This 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) Questionnaire	10 months after randomisation	EuroQol-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.

Trial Locations

Locations (4)

Centro de Salud Familiar 30 de Marzo; 🇨🇱 San Antonio, Chile

Centro de Salud Familiar Barrancas; 🇨🇱 San Antonio, Chile

Centro de Salud Familiar Nestor Fernandez; 🇨🇱 San Antonio, Chile

Centro de Salud Familiar San Antonio; 🇨🇱 San Antonio, Chile