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NCT03090828 Clinical Trial

Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease

Kidney Transplantation Clinical Trial

— PIC-R  

Official title:
Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03090828
Other study ID # *P150958
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 20, 2017
Last updated March 21, 2017
Start date September 2017
Est. completion date March 2022

Study information
Verified date February 2017
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1600
Est. completion date March 2022
Est. primary completion date March 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- severe end-stage renal disease Internet, literacy informed consent

Exclusion Criteria:

- did not fill the screening questionnaire

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• app-based therapeutic education
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
• enhanced app-based therapeutic education
Patients in the enhanced app group will also have access to a social network. (forum, chat room)

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Centre Leon Berard, Ministry of Health, France, Paris School of economics, Telecom Bretagne, Université Montpellier

Outcome
Type Measure Description Time frame Safety issue
Primary cost utility, efficiency, budget impact incremental cost utility ratio 18 months
Secondary overall survival percent of patients alive at 18 months 18 months
Secondary compliance and persistence percent of patients using the app at 18 months 18 months
Secondary disease knowledge answers to a questionnaire and change in the number of correct answers 18 months
Secondary lifestyle changes in risk factors 18 months
Secondary app utilization by professionals and patients number of connections, shares, likes 18 months
Secondary health care delivery organization number of interactions (chats) between healthcare professionals and patients 18 months
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