Clinical trial NCT03891771: Seniors Guardian: A Monitoring Platform for the Elderly
Official title: Seniors Guardian: A Non-intrusive Monitoring Platform for Activities of Daily Living Amongst the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Elderly
Activities of daily living
Telemonitoring
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Servicio de Vivienda y Urbanismo, Chile
name: Ilustre Municipalidad de San Antonio, Chile
name: Corporación Municipal de Valparaíso, Chile
First posted: 2019-03-27
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

* 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

Primary outcomes:
measure: Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 1 month after randomisation
measure: Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 5 months after randomisation
measure: Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 10 months after randomisation
measure: Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire
timeFrame: 1 month after randomisation
measure: Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire
timeFrame: 5 months after randomisation
measure: Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire
timeFrame: 10 months after randomisation
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: Chile
facility: Centro de Salud Familiar 30 de Marzo
city: San Antonio
country: Chile
facility: Centro de Salud Familiar Barrancas
city: San Antonio
country: Chile
facility: Centro de Salud Familiar Nestor Fernandez
city: San Antonio
country: Chile
facility: Centro de Salud Familiar San Antonio
Study officials:
affiliation: Universidad de Valparaiso
name: Carla Taramasco, Ph.D.
role: STUDY_CHAIR
affiliation: Universidad Andres Bello
name: Felipe T Martinez, M.D., M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med. 2008 Feb 19;148(4):W60-6. doi: 10.7326/0003-4819-148-4-200802190-00008-w1.
citation: Stoddart A, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Padfield P, McKinstry B. Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial. BMJ Open. 2013 May 28;3(5):e002681. doi: 10.1136/bmjopen-2013-002681.
citation: Lewis KE, Annandale JA, Warm DL, Hurlin C, Lewis MJ, Lewis L. Home telemonitoring and quality of life in stable, optimised chronic obstructive pulmonary disease. J Telemed Telecare. 2010;16(5):253-9. doi: 10.1258/jtt.2009.090907. Epub 2010 May 18.