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Seniors Guardian: A Monitoring Platform for the Elderly

NCT ID: NCT03891771

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2021-06-06

Brief Summary

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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

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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.

Conditions

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Quality of Life

Keywords

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Elderly Activities of daily living Telemonitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Usual Care

Patients allocated to usual care will receive standard follow-up procedures at their primary care facility.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Telemonitoring sensors

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servicio de Vivienda y Urbanismo, Chile

UNKNOWN

Sponsor Role collaborator

Ilustre Municipalidad de San Antonio, Chile

UNKNOWN

Sponsor Role collaborator

Corporación Municipal de Valparaíso, Chile

UNKNOWN

Sponsor Role collaborator

Universidad de Valparaiso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carla Taramasco, Ph.D.

Role: STUDY_CHAIR

Universidad de Valparaiso

Felipe T Martinez, M.D., M.Sc

Role: PRINCIPAL_INVESTIGATOR

Universidad Andres Bello

Locations

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Centro de Salud Familiar 30 de Marzo

San Antonio, , Chile

Site Status

Centro de Salud Familiar Barrancas

San Antonio, , Chile

Site Status

Centro de Salud Familiar Nestor Fernandez

San Antonio, , Chile

Site Status

Centro de Salud Familiar San Antonio

San Antonio, , Chile

Site Status

Countries

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Chile

References

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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. doi: 10.1046/j.1532-5415.2001.49188.x.

Reference Type BACKGROUND
PMID: 11527489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18283201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23793650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20483881 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/books/NBK260871/

Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure : systematic review and economic evaluation Scientific summary

http://www.scielo.cl/pdf/rmc/v139n5/art03.pdf

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

Other Identifiers

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CEC181-18

Identifier Type: -

Identifier Source: org_study_id