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

Not Applicable

• Conditions: Kidney Transplantation; End-stage Renal Disease; Dialysis
• Interventions: Behavioral: app-based therapeutic education; Behavioral: enhanced app-based therapeutic education

• Registration Number: NCT03090828
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-21
• Last Update Submitted: 2017-03-21
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-27
• Study Start: 2017-09
• Primary Completion: 2021-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

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

Exclusion Criteria

• did not fill the screening questionnaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
app-based therapeutic education	app-based therapeutic education	patients will have access to the app providing information of the disease as well as educational guidelines
enhanced app-based therapeutic education	enhanced app-based therapeutic education	patients will also have access to a chat room and discussion forum

Primary Outcome Measures

Name	Time	Method
cost utility, efficiency, budget impact	18 months	incremental cost utility ratio

Secondary Outcome Measures

Name	Time	Method
overall survival	18 months	percent of patients alive at 18 months
disease knowledge	18 months	answers to a questionnaire and change in the number of correct answers
compliance and persistence	18 months	percent of patients using the app at 18 months
lifestyle	18 months	changes in risk factors
app utilization by professionals and patients	18 months	number of connections, shares, likes
health care delivery organization	18 months	number of interactions (chats) between healthcare professionals and patients