AgingACCORDSNCT04514536
Evaluation of a Health Monitoring Platform for Elderly in Home Care Context
A study testing Health monitors in people with Aging and Frailty, run by Rennes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- What is being tested?
- Health monitors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2020to 4 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combinatorial Approach of Connected Functions for Multimodal Health Data Collection
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.
- Being tested
- Health monitors
- Keywords
- Health monitoring, Frailty, Home care, Home support
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health monitorsDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Health monitoring | Experimental | Subjects have to monitor their health autonomously using the monitoring platform (connected health devices and app on the touchpad). Receives: Device: Health monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beliefs modified questionnaire
questionnaire by Fishbein \& Ajzen (1975), is a qualitative questionnaire, with no scoring
Measured: 1 month
UTAUT modified questionnaire
questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
Measured: 1 month
Usability SUS questionnaire
questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
Measured: 1 month
Comfort modified questionnaire
questionnaire by Knight \& Baber (2005) Final score is graded 11 to 77, 77 being the best score
Measured: 1 month
Secondary outcomes (13)
Motivation modified questionnaire
questionnaire by Deci \& Ryan (1987), is a qualitative questionnaire, with no scoring
Measured: inclusion
Beliefs modified questionnaire
questionnaire by Fishbein \& Ajzen (1975), is a qualitative questionnaire, with no scoring
Measured: inclusion
Beliefs modified questionnaire
a priori acceptability questionnaire by Fishbein \& Ajzen (1975), is a qualitative questionnaire, with no scoring
Measured: 12 months
Beliefs modified questionnaire
a priori acceptability questionnaire by Fishbein \& Ajzen (1975), is a qualitative questionnaire, with no scoring
Measured: 24 months
UTAUT modified questionnaire
questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
Measured: inclusion
UTAUT modified questionnaire
questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
Measured: 12 months
UTAUT modified questionnaire
questionnaire by Venkatesh et al. (2003) Final score is graded 1 to 10, 10 being the best score
Measured: 24 months
Comfort modified questionnaire
questionnaire by Knight \& Baber (2005) Final score is graded 11 to 77, 77 being the best score
Measured: inclusion
Comfort modified questionnaire
questionnaire by Knight \& Baber (2005) Final score is graded 11 to 77, 77 being the best score
Measured: 12 months
Comfort modified questionnaire
questionnaire by Knight \& Baber (2005) Final score is graded 11 to 77, 77 being the best score
Measured: 24 months
Usability SUS questionnaire
questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
Measured: inclusion
Usability SUS questionnaire
questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
Measured: 12 months
Usability SUS questionnaire
questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start10 Sep 2020
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AZNetwork, RF-Track, University of Rennes
- Responsible party
- Sponsor
- Investigators
- Dominique SOMME, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514536
- Sponsor's protocol ID
- 2019-A02316-51
- Acronym
- ACCORDS
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinatorial Approach of Connected Functions for Multimodal Health Data Collection
- ClinicalTrials.gov ID
- NCT04514536
- Acronym / sponsor ID
- ACCORDS / 2019-A02316-51
- Keywords
- Health monitoring, Frailty, Home care, Home support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- AZNetwork, RF-Track, University of Rennes
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health monitoring | Experimental | Device: Health monitorsSubjects have to monitor their health autonomously using the monitoring platform (connected health devices and app on the touchpad). |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health monitors* 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. | Device | Health monitoring |
Primary outcome
Beliefs modified questionnaire
Time frame: 1 month
questionnaire by Fishbein \& Ajzen (1975), is a qualitative questionnaire, with no scoring
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
Usability SUS questionnaire
Time frame: 1 month
questionnaire by Brooks (1996) Final score is graded 10 to 70, 70 being the best score
Comfort modified questionnaire
Time frame: 1 month
questionnaire by Knight \& Baber (2005) Final score is graded 11 to 77, 77 being the best score
13 secondary outcomes
Motivation modified questionnaire
Time frame: inclusion
Beliefs modified questionnaire
Time frame: inclusion
Beliefs modified questionnaire
Time frame: 12 months
Beliefs modified questionnaire
Time frame: 24 months
UTAUT modified questionnaire
Time frame: inclusion
UTAUT modified questionnaire
Time frame: 12 months
UTAUT modified questionnaire
Time frame: 24 months
Comfort modified questionnaire
Time frame: inclusion
Comfort modified questionnaire
Time frame: 12 months
Comfort modified questionnaire
Time frame: 24 months
Usability SUS questionnaire
Time frame: inclusion
Usability SUS questionnaire
Time frame: 12 months
Usability SUS questionnaire
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique SOMME, MD, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health monitors in people with Aging and Frailty, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs modified questionnaire (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.