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

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ClinicalTrials.gov Identifier: NCT03090828
Recruitment Status : Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
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
Criteria

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
ClinicalTrials.gov 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