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

Study Overview
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Brief Summary
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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

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

Conditions
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End-stage Renal Disease, Dialysis, Kidney Transplantation

Intervention / Treatment
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* Behavioral: app-based therapeutic education
* Behavioral: enhanced app-based therapeutic education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe end-stage renal disease Internet, literacy informed consent Exclusion Criteria: did not fill the screening questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>treatment as usual will be provided to patients | |
| Active Comparator: app-based therapeutic education<br>patients will have access to the app providing information of the disease as well as educational guidelines | Behavioral: app-based therapeutic education<br>* Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.<br>|
| Experimental: enhanced app-based therapeutic education<br>patients will also have access to a chat room and discussion forum | Behavioral: enhanced app-based therapeutic education<br>* Patients in the enhanced app group will also have access to a social network. (forum, chat room)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost utility, efficiency, budget impact | incremental cost utility ratio | 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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economic evaluation, e health