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Completed

NCT Number: NCT04514536

Evaluation of a Health Monitoring Platform for Elderly in Home Care Context

This study aims at, as a primary objective, studying acceptability of elderly about a health monitoring platform for home support and home care. The secondary objective consists in studying the correlation of different health data evolution and the frailty trajectory of the subject.

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Key information

Conditions

Aging Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rennes

Rennes, France, 35000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 80 years old
  • Living at home or in senior residence
  • Evaluated as being robust according to the Fried's frailty test (0 met criteria)
  • Affiliated or beneficiary of a social protection scheme
  • Having given written consent

Exclusion criteria

  • Hospitalization during the month preceding the first visit
  • Subject suffering from cognitive disorders preventing proper use of the device
  • Subject being unable to give by himself / herself his / her consent to participate in the trial
  • Person subject to legal protection (safeguard of justice, trusteeship, guardianship, persons deprived of liberty)

Treatment and study plan

Health monitors

Device
  • The connected scale (iHealth HS2) measures weight from 5 to 180kg and BMI.
  • The connected actimeter (iHealth AM4) monitors activity (number of steps, distance, calories), sleep (automatic sleep recognition, effective sleep time, number of awakenings) and swimming (automatic activity recognition, session duration, swim type recognition and number of laps).
  • The connected blood pressure monitor (iHealth Track KN-550BT)is a medical device that measures blood pressure and pulse rate.
  • The activity monitor (manufactured by RF Track) consists of a housing that can be positioned as a pendant or at the hip. It includes an accelerometer, gyroscope, magnetometer, barometer, radio transceiver, and led. The sensor records the raw signals.
  • The touchpad allows the subject to connect to the Calliope app. This app allows the data recovery, storage, analysis, visualization, and all the required settings for the platform to work together.

Primary outcomes

  1. Beliefs modified questionnaire

    Time frame: 1 month

    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  2. UTAUT modified questionnaire

    Time frame: 1 month

    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  3. Usability SUS questionnaire

    Time frame: 1 month

    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  4. Comfort modified questionnaire

    Time frame: 1 month

    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

Secondary outcomes

  1. Motivation modified questionnaire

    Time frame: inclusion

    questionnaire by Deci & Ryan (1987), is a qualitative questionnaire, with no scoring

  2. Beliefs modified questionnaire

    Time frame: inclusion

    questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  3. Beliefs modified questionnaire

    Time frame: 12 months

    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  4. Beliefs modified questionnaire

    Time frame: 24 months

    a priori acceptability questionnaire by Fishbein & Ajzen (1975), is a qualitative questionnaire, with no scoring

  5. UTAUT modified questionnaire

    Time frame: inclusion

    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  6. UTAUT modified questionnaire

    Time frame: 12 months

    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  7. UTAUT modified questionnaire

    Time frame: 24 months

    questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score

  8. Comfort modified questionnaire

    Time frame: inclusion

    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  9. Comfort modified questionnaire

    Time frame: 12 months

    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  10. Comfort modified questionnaire

    Time frame: 24 months

    questionnaire by Knight & Baber (2005) Final score is graded 11 to 77, 77 being the best score

  11. Usability SUS questionnaire

    Time frame: inclusion

    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  12. Usability SUS questionnaire

    Time frame: 12 months

    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

  13. Usability SUS questionnaire

    Time frame: 24 months

    questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • AZNetwork
  • RF-Track
  • University of Rennes

Registry information

Official study title

Combinatorial Approach of Connected Functions for Multimodal Health Data Collection

Acronym: ACCORDS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2020
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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