Chronic Renal FailureMEDIANCT03927300
Telemonitoring Impact by the ApTelecare Software in Dialysis Patient
An observational study of Chronic Renal Failure and Dialysis Related Complication, run by Tmm Software at 1 site in France.
Trial summary
The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Dialysis Related Complication
- What is being tested?
- Telemonitoring Software
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2019to 11 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a chronic renal failure who are take care in the dialysis unit. These patients are their peritoneal dialysis at home and use or not the telemonitoring software "ApTelecare".
Who may be able to join
- Adult patients (≥ 18 years) with no age limit;
- Patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (Group1) and between 2016 and 2018 (Group 2);
- Patient information in this retrospective study;
Who cannot join
- Patients who have started a peritoneal dialysis program before the periods of investigation;
- Patients who have been equipped with apTeleCare during the dialysis program;
- Subject under guardianship, curators or safeguard of justice;
- Patient not affiliated to a French social protection;
Trial locations and contacts
1 site in 1 country.
About this study
The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).
- Being tested
- Telemonitoring Software
- Keywords
- Home Peritoneal Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring SoftwareDevice
Recovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application.
| Study group | Role | What they receive |
|---|---|---|
| Patients without Telemonitoring with ApTelecare Software | Not described | |
| Patients with implementation of Telemonitoring with ApTelecare | Not described Receives: Device: Telemonitoring Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.
Measured: up to two years.
Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.
Measured: up to two years.
Secondary outcomes (6)
Total length of hospitalisation
Measured: For both groups. Every two months (follow-up visit) on a retrospective period of two years, the outcome 2 will be measured. The study duration will be of 5 months
Number of events of cardiovascular complications
Measured: For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
Mortality rate
Measured: For both groups. At the end of this retrospective study (Study Period of 5 months).
Rate of peritoneal infections
Measured: For both groups. At the end of this retrospective study.(Study Period of 5 months).
Number of patient exit technique except death
For example transplant, hemodialysis
Measured: For both groups. At the end of this retrospective study. (Study Period of 5 months).
Charlson score : Comorbidity index
This scale measure the comorbidity symptoms of patients at the beginning of the care by the physician. The minimum score will be "0" and the maximum will be 39.
Its validation is based on a prediction of health French insurance, as well as on several clinical areas such as oncology or nephrology.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start17 Jul 2019
- Primary completion17 Jul 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tmm Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier de Vichy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927300
- Sponsor's protocol ID
- KM-00153
- Acronym
- MEDIA
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring Impact by the ApTelecare Software in Dialysis Patient
- ClinicalTrials.gov ID
- NCT03927300
- Acronym / sponsor ID
- MEDIA / KM-00153
- Keywords
- Home Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tmm SoftwareIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier de Vichy
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 25 Apr 2019 (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.
The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Telemonitoring with ApTelecare Software | – | – |
| Patients with implementation of Telemonitoring with ApTelecare | – | Device: Telemonitoring Software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a chronic renal failure who are take care in the dialysis unit. These patients are their peritoneal dialysis at home and use or not the telemonitoring software "ApTelecare".
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years) with no age limit;
- Patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (Group1) and between 2016 and 2018 (Group 2);
- Patient information in this retrospective study;
Key exclusion criteria (4 listed)
- Patients who have started a peritoneal dialysis program before the periods of investigation;
- Patients who have been equipped with apTeleCare during the dialysis program;
- Subject under guardianship, curators or safeguard of justice;
- Patient not affiliated to a French social protection;
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 |
|---|---|---|
| Telemonitoring SoftwareRecovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application. | Device | Patients with implementation of Telemonitoring with ApTelecare |
Primary outcome
Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.
Time frame: up to two years.
Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.
Time frame: up to two years.
6 secondary outcomes
Total length of hospitalisation
Time frame: For both groups. Every two months (follow-up visit) on a retrospective period of two years, the outcome 2 will be measured. The study duration will be of 5 months
Number of events of cardiovascular complications
Time frame: For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
Mortality rate
Time frame: For both groups. At the end of this retrospective study (Study Period of 5 months).
Rate of peritoneal infections
Time frame: For both groups. At the end of this retrospective study.(Study Period of 5 months).
Number of patient exit technique except death
Time frame: For both groups. At the end of this retrospective study. (Study Period of 5 months).
Charlson score : Comorbidity index
Time frame: baseline
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 10 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure and Dialysis Related Complication, run by Tmm Software 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 3 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 10 Mar 2020. 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?
Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups. (time frame: up to two years.). The study lists 2 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 10 Mar 2020.