Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
PIC-R
Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
1 other identifier
interventional
1,600
0 countries
N/A
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 27, 2017
February 1, 2017
3.5 years
February 20, 2017
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cost utility, efficiency, budget impact
incremental cost utility ratio
18 months
Secondary Outcomes (6)
overall survival
18 months
compliance and persistence
18 months
disease knowledge
18 months
lifestyle
18 months
app utilization by professionals and patients
18 months
- +1 more secondary outcomes
Study Arms (3)
control
NO INTERVENTIONtreatment as usual will be provided to patients
app-based therapeutic education
ACTIVE COMPARATORpatients will have access to the app providing information of the disease as well as educational guidelines
enhanced app-based therapeutic education
EXPERIMENTALpatients will also have access to a chat room and discussion forum
Interventions
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
Patients in the enhanced app group will also have access to a social network. (forum, chat room)
Eligibility Criteria
You may qualify if:
- severe end-stage renal disease Internet, literacy informed consent
You may not qualify if:
- did not fill the screening questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Centre Leon Berardcollaborator
- Université Montpelliercollaborator
- Telecom Bretagnecollaborator
- Paris School of Economicscollaborator
- Ministry of Health, Francecollaborator
Related Publications (1)
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.
PMID: 36600325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 27, 2017
Study Start
September 1, 2017
Primary Completion
March 1, 2021
Study Completion
March 1, 2022
Last Updated
March 27, 2017
Record last verified: 2017-02