Chronic Renal FailureHSMDPNCT03019159
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis
An observational study of Chronic Renal Failure and Peritoneal Dialysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Peritoneal Dialysis
- What is being tested?
- Teleconsulting
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Sep 2016
- 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 renal failure under peritoneal dialysis
Who may be able to join
- Patient under peritoneal dialysis for more than three month
- Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals
- Patients or health care professionnals thought to be able to use telemedicine
Who cannot join
- No DSL Network
- No GSM Network
- Patients who can not express their opposition to the participation to this study because of limited mental abilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis
The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event
- Conditions
- Chronic Renal Failure, Peritoneal Dialysis
- Being tested
- Teleconsulting
- 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.
TeleconsultingDevice
Also called Telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Tele-consulting | One visit out of two takes place with teleconsulting and the other is a face-to-face consultation Receives: Device: Teleconsulting | |
| No tele-consulting | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe adverse events
Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia > 40 mmol/L
Measured: Within 2 years after enrollment
Secondary outcomes (7)
Number of hospitalisations
Measured: Within 2 years after enrollment
Number of consultations
Measured: Within 2 years after enrollment
Number of sanitary transportation
Measured: Within 2 years after enrollment
Mean length of hospital stay
Measured: Within 2 years after enrollment
Global costs
Measured: 6 months after the first patient enrollment
Patients satisfaction
Measured: 1 year after enrollment
Satisfaction of the professionnals
Measured: 6 months after enrollment of the first patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Why it stopped: Support funding of the regional health authority stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Stéphane Roueff, MD, Principal investigator, Pôle CTIRC. Hôpitaux Saint MauriceIsabelle Durand-Zaleski, MD, PhD, Principal investigator, DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019159
- Sponsor's protocol ID
- TLM-HSMDP
- Acronym
- HSMDP
- Status last verified
- Jun 2014
- First submitted
- 10 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.
PubMed 17785025Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
PubMed 22617736
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-effectiveness Assessment of a Follow-up With Tele-consulting for Patients With Chronic Renal Failure Under Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03019159
- Acronym / sponsor ID
- HSMDP / TLM-HSMDP
- Conditions
- Chronic Renal Failure, Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Support funding of the regional health authority stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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 objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-consulting | – | Device: TeleconsultingOne visit out of two takes place with teleconsulting and the other is a face-to-face consultation |
| No tele-consulting | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with renal failure under peritoneal dialysis
Key inclusion criteria (3 listed)
- Patient under peritoneal dialysis for more than three month
- Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals
- Patients or health care professionnals thought to be able to use telemedicine
Key exclusion criteria (3 listed)
- No DSL Network
- No GSM Network
- Patients who can not express their opposition to the participation to this study because of limited mental abilities
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 |
|---|---|---|
| TeleconsultingAlso: Telemedicine | Device | Tele-consulting |
Primary outcome
Severe adverse events
Time frame: Within 2 years after enrollment
Death, Peritonitis, acute pulmonary edema, symptomatic hyperkalemia or with EKG signs, severe and resistant hypertension, with uremia > 40 mmol/L
7 secondary outcomes
Number of hospitalisations
Time frame: Within 2 years after enrollment
Number of consultations
Time frame: Within 2 years after enrollment
Number of sanitary transportation
Time frame: Within 2 years after enrollment
Mean length of hospital stay
Time frame: Within 2 years after enrollment
Global costs
Time frame: 6 months after the first patient enrollment
Patients satisfaction
Time frame: 1 year after enrollment
Satisfaction of the professionnals
Time frame: 6 months after enrollment of the first patient
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 17785025Gallar P, Vigil A, Rodriguez I, Ortega O, Gutierrez M, Hurtado J, Oliet A, Ortiz M, Mon C, Herrero JC, Lentisco C. Two-year experience with telemedicine in the follow-up of patients in home peritoneal dialysis. J Telemed Telecare. 2007;13(6):288-92. doi: 10.1258/135763307781644906.
- Background: PubMed 22617736Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
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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.
Stéphane Roueff, MD principal investigator
Pôle CTIRC. Hôpitaux Saint Maurice
Isabelle Durand-Zaleski, MD, PhD principal investigator
DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
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 Peritoneal Dialysis, run by Assistance Publique - Hôpitaux de Paris 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 3 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: withdrawn, as of the sponsor's last update on 12 Jan 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Severe adverse events (time frame: Within 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019159, which also lists 2 linked publications.
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 12 Jan 2017.