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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End-stage Renal Disease focused on measuring economic evaluation, e health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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