NCT03891771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2021

Completed
Last Updated

November 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

March 25, 2019

Last Update Submit

November 19, 2021

Conditions

Quality of Life

Keywords

ElderlyActivities of daily livingTelemonitoring

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Usual Care

NO INTERVENTION

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

Telemonitoring sensors

EXPERIMENTAL

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

Interventions

Telemonitoring sensorsDEVICE

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.

Telemonitoring sensors

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centro de Salud Familiar 30 de Marzo

San Antonio, Chile

Location

Centro de Salud Familiar Barrancas

San Antonio, Chile

Location

Centro de Salud Familiar Nestor Fernandez

San Antonio, Chile

Location

Centro de Salud Familiar San Antonio

San Antonio, Chile

Location

Related Publications (4)

  • 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.

    PMID: 11527489BACKGROUND

  • 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.

    PMID: 18283201BACKGROUND

  • 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.

    PMID: 23793650BACKGROUND

  • 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.

    PMID: 20483881BACKGROUND

Related Links

Study Officials

  • Carla Taramasco, Ph.D.

    Universidad de Valparaiso

    STUDY CHAIR

  • Felipe T Martinez, M.D., M.Sc

    Universidad Andres Bello

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

April 30, 2019

Primary Completion

June 6, 2021

Study Completion

June 6, 2021

Last Updated

November 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CL(4)