Seniors Guardian: A Monitoring Platform for the Elderly

Quality of Life Clinical Trial

— SEMONE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891771
• Other study ID #: CEC181-18
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: June 6, 2021

Study information

• Verified date: October 2021
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 6, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Device:
• Telemonitoring 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.

Locations

Country	Name	City	State
Chile	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

Sponsors (4)

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

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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. — View 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. — View Citation

Robinson BE, Barry PP, Renick N, Bergen MR, Stratos GA. Physician confidence and interest in learning more about common geriatric topics: a needs assessment. J Am Geriatr Soc. 2001 Jul;49(7):963-7. — View 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). pii: e002681. doi: 10.1136/bmjopen-2013-002681. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	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.	1 month after randomisation
Primary	Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	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.	5 months after randomisation
Primary	Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)	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.	10 months after randomisation
Primary	Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire	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.	1 month after randomisation
Primary	Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire	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.	5 months after randomisation
Primary	Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire	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.	10 months after randomisation

External Links

•   Espinoza I, Osorio P, Torrejón MJ, Lucas-Carrasco R, Bunout D. Validación del cuestionario de calidad de vida (WHOQOL-BREF) en adultos mayores chilenos. Rev Med Chile [Internet]. 2011;579-86
•   Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure : systematic review and economic evaluation Scientific summary