Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease (PIC-R)
Primary Purpose
End-stage Renal Disease, Dialysis, Kidney Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
app-based therapeutic education
enhanced app-based therapeutic education
Sponsored by
About this trial
This is an interventional supportive care trial for End-stage Renal Disease focused on measuring economic evaluation, e health
Eligibility Criteria
Inclusion Criteria:
- severe end-stage renal disease Internet, literacy informed consent
Exclusion Criteria:
- did not fill the screening questionnaire
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
control
app-based therapeutic education
enhanced app-based therapeutic education
Arm Description
treatment as usual will be provided to patients
patients will have access to the app providing information of the disease as well as educational guidelines
patients will also have access to a chat room and discussion forum
Outcomes
Primary Outcome Measures
cost utility, efficiency, budget impact
incremental cost utility ratio
Secondary Outcome Measures
overall survival
percent of patients alive at 18 months
compliance and persistence
percent of patients using the app at 18 months
disease knowledge
answers to a questionnaire and change in the number of correct answers
lifestyle
changes in risk factors
app utilization by professionals and patients
number of connections, shares, likes
health care delivery organization
number of interactions (chats) between healthcare professionals and patients
Full Information
NCT ID
NCT03090828
First Posted
February 20, 2017
Last Updated
March 21, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre Leon Berard, Université Montpellier, Telecom Bretagne, Paris School of Economics, Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT03090828
Brief Title
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
Acronym
PIC-R
Official Title
Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Centre Leon Berard, Université Montpellier, Telecom Bretagne, Paris School of Economics, Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Dialysis, Kidney Transplantation
Keywords
economic evaluation, e health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
treatment as usual will be provided to patients
Arm Title
app-based therapeutic education
Arm Type
Active Comparator
Arm Description
patients will have access to the app providing information of the disease as well as educational guidelines
Arm Title
enhanced app-based therapeutic education
Arm Type
Experimental
Arm Description
patients will also have access to a chat room and discussion forum
Intervention Type
Behavioral
Intervention Name(s)
app-based therapeutic education
Intervention Description
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
Intervention Type
Behavioral
Intervention Name(s)
enhanced app-based therapeutic education
Intervention Description
Patients in the enhanced app group will also have access to a social network. (forum, chat room)
Primary Outcome Measure Information:
Title
cost utility, efficiency, budget impact
Description
incremental cost utility ratio
Time Frame
18 months
Secondary Outcome Measure Information:
Title
overall survival
Description
percent of patients alive at 18 months
Time Frame
18 months
Title
compliance and persistence
Description
percent of patients using the app at 18 months
Time Frame
18 months
Title
disease knowledge
Description
answers to a questionnaire and change in the number of correct answers
Time Frame
18 months
Title
lifestyle
Description
changes in risk factors
Time Frame
18 months
Title
app utilization by professionals and patients
Description
number of connections, shares, likes
Time Frame
18 months
Title
health care delivery organization
Description
number of interactions (chats) between healthcare professionals and patients
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
severe end-stage renal disease Internet, literacy informed consent
Exclusion Criteria:
did not fill the screening questionnaire
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
JPAL plans to share the de-identified patient database
Learn more about this trial
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
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