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Clinical Trials/NCT03891771
NCT03891771
Completed
Not Applicable

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

Universidad de Valparaiso4 sites in 1 country69 target enrollmentApril 30, 2019
ConditionsQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Universidad de Valparaiso
Enrollment
69
Locations
4
Primary Endpoint
Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2019
End Date
June 6, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)

Time Frame: 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

Time Frame: 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.

Study Sites (4)

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