Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease (PIC-R)
March 21, 2017 updated by: Assistance Publique - Hôpitaux de Paris
Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
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
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1600
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- severe end-stage renal disease Internet, literacy informed consent
Exclusion Criteria:
- did not fill the screening questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
treatment as usual will be provided to patients
|
|
|
Active Comparator: app-based therapeutic education
patients will have access to the app providing information of the disease as well as educational guidelines
|
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
|
|
Experimental: enhanced app-based therapeutic education
patients will also have access to a chat room and discussion forum
|
Patients in the enhanced app group will also have access to a social network.
(forum, chat room)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cost utility, efficiency, budget impact
Time Frame: 18 months
|
incremental cost utility ratio
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: 18 months
|
percent of patients alive at 18 months
|
18 months
|
|
compliance and persistence
Time Frame: 18 months
|
percent of patients using the app at 18 months
|
18 months
|
|
disease knowledge
Time Frame: 18 months
|
answers to a questionnaire and change in the number of correct answers
|
18 months
|
|
lifestyle
Time Frame: 18 months
|
changes in risk factors
|
18 months
|
|
app utilization by professionals and patients
Time Frame: 18 months
|
number of connections, shares, likes
|
18 months
|
|
health care delivery organization
Time Frame: 18 months
|
number of interactions (chats) between healthcare professionals and patients
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2017
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- *P150958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
JPAL plans to share the de-identified patient database
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.