End-stage Renal DiseasePIC-RNCT03090828
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
A study testing app-based therapeutic education and enhanced app-based therapeutic education in people with End-stage Renal Disease and Dialysis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages. The total follow up duration is 18 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, Dialysis, Kidney Transplantation
- What is being tested?
- app-based therapeutic education and enhanced app-based therapeutic education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe end-stage renal disease Internet, literacy informed consent
Who cannot join
- did not fill the screening questionnaire
About this study
Official title: Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages.
The total follow up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention, secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), budget impact analysis
- Conditions
- End-stage Renal Disease, Dialysis, Kidney Transplantation
- Being tested
- app-based therapeutic education, enhanced app-based therapeutic education
- Keywords
- economic evaluation, e health
- 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.
app-based therapeutic educationBehavioural
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
enhanced app-based therapeutic educationBehavioural
Patients in the enhanced app group will also have access to a social network. (forum, chat room)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | treatment as usual will be provided to patients |
| app-based therapeutic education | Active comparator | patients will have access to the app providing information of the disease as well as educational guidelines Receives: Behavioral: app-based therapeutic education |
| enhanced app-based therapeutic education | Experimental | patients will also have access to a chat room and discussion forum Receives: Behavioral: enhanced app-based therapeutic education |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost utility, efficiency, budget impact
incremental cost utility ratio
Measured: 18 months
Secondary outcomes (6)
overall survival
percent of patients alive at 18 months
Measured: 18 months
compliance and persistence
percent of patients using the app at 18 months
Measured: 18 months
disease knowledge
answers to a questionnaire and change in the number of correct answers
Measured: 18 months
lifestyle
changes in risk factors
Measured: 18 months
app utilization by professionals and patients
number of connections, shares, likes
Measured: 18 months
health care delivery organization
number of interactions (chats) between healthcare professionals and patients
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startSep 2017 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Leon Berard, Université Montpellier, Telecom Bretagne, Paris School of Economics, Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090828
- Sponsor's protocol ID
- *P150958
- Acronym
- PIC-R
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: JPAL plans to share the de-identified patient database
Publications
Pillebout E, Durand-Zaleski I, Farge L, Perrier L, de Chaisemartin C, Dupont JCK, Behaghel L, Rochaix L; Paris School of Economics and AP-HP Hospinnomics, Paris, France. Multicentre, randomised, economic evaluation of a web-based interactive education platform, simple or enhanced, for patients with end-stage renal disease: the PIC-R trial protocol. BMJ Open. 2022 Dec 9;12(12):e062613. doi: 10.1136/bmjopen-2022-062613.
PubMed 36600325
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
- ClinicalTrials.gov ID
- NCT03090828
- Acronym / sponsor ID
- PIC-R / *P150958
- Conditions
- End-stage Renal Disease, Dialysis, Kidney Transplantation
- Keywords
- economic evaluation, e health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre Leon Berard, Université Montpellier, Telecom Bretagne, Paris School of Economics, Ministry of Health, France
- Study start
- Sep 2017 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Mar 2017 (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.
1600 patients with severe, end stage renal disease or post transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific app; or the enhanced interactive app using feedback messages.
The total follow up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention, secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), budget impact analysis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –treatment as usual will be provided to patients |
| app-based therapeutic education | Active comparator | Behavioral: app-based therapeutic educationpatients will have access to the app providing information of the disease as well as educational guidelines |
| enhanced app-based therapeutic education | Experimental | Behavioral: enhanced app-based therapeutic educationpatients will also have access to a chat room and discussion forum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe end-stage renal disease Internet, literacy informed consent
Key exclusion criteria (1 listed)
- did not fill the screening questionnaire
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 |
|---|---|---|
| app-based therapeutic educationPatients will connect to a platform providing information on end-stage renal disease and to contact health care providers. | Behavioural | app-based therapeutic education |
| enhanced app-based therapeutic educationPatients in the enhanced app group will also have access to a social network. (forum, chat room) | Behavioural | enhanced app-based therapeutic education |
Primary outcome
cost utility, efficiency, budget impact
Time frame: 18 months
incremental cost utility ratio
6 secondary outcomes
overall survival
Time frame: 18 months
compliance and persistence
Time frame: 18 months
disease knowledge
Time frame: 18 months
lifestyle
Time frame: 18 months
app utilization by professionals and patients
Time frame: 18 months
health care delivery organization
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Derived from this study: PubMed 36600325Pillebout E, Durand-Zaleski I, Farge L, Perrier L, de Chaisemartin C, Dupont JCK, Behaghel L, Rochaix L; Paris School of Economics and AP-HP Hospinnomics, Paris, France. Multicentre, randomised, economic evaluation of a web-based interactive education platform, simple or enhanced, for patients with end-stage renal disease: the PIC-R trial protocol. BMJ Open. 2022 Dec 9;12(12):e062613. doi: 10.1136/bmjopen-2022-062613.
- Individual participant dataSharing planned: Undecided. JPAL plans to share the de-identified patient database
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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.
Questions about this trial
What is this clinical trial studying?
A study testing app-based therapeutic education and enhanced app-based therapeutic education in people with End-stage Renal Disease and Dialysis, run by Assistance Publique - Hôpitaux de Paris.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
cost utility, efficiency, budget impact (time frame: 18 months). 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 NCT03090828, which also lists 1 linked publication.
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 27 Mar 2017.