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Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease (PIC-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090828
Recruitment Status : Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Centre Leon Berard
Université Montpellier
Telecom Bretagne
Paris School of economics
Ministry of Health, France
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Dialysis Kidney Transplantation Behavioral: app-based therapeutic education Behavioral: enhanced app-based therapeutic education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Economic Evaluation of an Interactive Community-based Patient Education Platform Kidney Dialysis and Transplantation
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

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
Behavioral: app-based therapeutic education
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
Behavioral: enhanced app-based therapeutic education
Patients in the enhanced app group will also have access to a social network. (forum, chat room)

Primary Outcome Measures :
  1. cost utility, efficiency, budget impact [ Time Frame: 18 months ]
    incremental cost utility ratio

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 18 months ]
    percent of patients alive at 18 months

  2. compliance and persistence [ Time Frame: 18 months ]
    percent of patients using the app at 18 months

  3. disease knowledge [ Time Frame: 18 months ]
    answers to a questionnaire and change in the number of correct answers

  4. lifestyle [ Time Frame: 18 months ]
    changes in risk factors

  5. app utilization by professionals and patients [ Time Frame: 18 months ]
    number of connections, shares, likes

  6. health care delivery organization [ Time Frame: 18 months ]
    number of interactions (chats) between healthcare professionals and patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • did not fill the screening questionnaire

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT03090828     History of Changes
Other Study ID Numbers: *P150958
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: JPAL plans to share the de-identified patient database

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
economic evaluation
e health
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency