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Seniors Guardian: A Monitoring Platform for the Elderly (SEMONE)

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ClinicalTrials.gov Identifier: NCT03891771
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
Servicio de Vivienda y Urbanismo, Chile
Ilustre Municipalidad de San Antonio, Chile
Corporación Municipal de Valparaíso, Chile
Information provided by (Responsible Party):
Universidad de Valparaiso

Study Description
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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.

Condition or disease Intervention/treatment Phase
Quality of Life Device: Telemonitoring sensors Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Seniors Guardian: A Non-intrusive Monitoring Platform for Activities of Daily Living Amongst the Elderly
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 23, 2020
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
Patients allocated to usual care will receive standard follow-up procedures at their primary care facility.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) [ Time Frame: 1 month 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.

  2. Overall Quality of Life score as measured by the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) [ Time Frame: 5 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.

  3. 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.

  4. Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire [ Time Frame: 1 month 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.

  5. Health-Related Quality of Life score using the EuroQOL-5D (EQ-5D) Questionnaire [ Time Frame: 5 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891771


Contacts
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Contact: Carla Taramasco, Ph.D. 2603636 ext +56 32 carla.taramasco@uv.cl

Locations
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Chile
Centro de Salud Familiar 30 de Marzo Recruiting
San Antonio, Chile
Contact: Rebeca Lopez       rebeca.lopez.arias@gmail.com   
Centro de Salud Familiar Barrancas Recruiting
San Antonio, Chile
Contact: Mindy Araya       mindyam@gmail.com   
Centro de Salud Familiar Nestor Fernandez Recruiting
San Antonio, Chile
Contact: Deyanira L Urrutia       deyanira_li@hotmail.com   
Centro de Salud Familiar San Antonio Recruiting
San Antonio, Chile
Contact: Paz Abarca       pazandreaabarca@gmail.com   
Sponsors and Collaborators
Universidad de Valparaiso
Servicio de Vivienda y Urbanismo, Chile
Ilustre Municipalidad de San Antonio, Chile
Corporación Municipal de Valparaíso, Chile
Investigators
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Study Chair: Carla Taramasco, Ph.D. Universidad de Valparaiso
Principal Investigator: Felipe T Martinez, M.D., M.Sc Universidad Andres Bello
More Information
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Additional Information:
Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure : systematic review and economic evaluation Scientific summary  This link exits the ClinicalTrials.gov site 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  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT03891771    
Other Study ID Numbers: CEC181-18
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Valparaiso:
Elderly
Activities of daily living
Telemonitoring