Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease

NCT ID: NCT03090828

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2022-03-31

Brief Summary

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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

Detailed Description

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Conditions

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End-stage Renal Disease Dialysis Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

treatment as usual will be provided to patients

Group Type NO_INTERVENTION

No interventions assigned to this group

app-based therapeutic education

patients will have access to the app providing information of the disease as well as educational guidelines

Group Type ACTIVE_COMPARATOR

app-based therapeutic education

Intervention Type BEHAVIORAL

Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.

enhanced app-based therapeutic education

patients will also have access to a chat room and discussion forum

Group Type EXPERIMENTAL

enhanced app-based therapeutic education

Intervention Type BEHAVIORAL

Patients in the enhanced app group will also have access to a social network. (forum, chat room)

Interventions

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app-based therapeutic education

Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.

Intervention Type BEHAVIORAL

enhanced app-based therapeutic education

Patients in the enhanced app group will also have access to a social network. (forum, chat room)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* did not fill the screening questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Leon Berard

OTHER

Sponsor Role collaborator

Université Montpellier

OTHER

Sponsor Role collaborator

Telecom Bretagne

UNKNOWN

Sponsor Role collaborator

Paris School of Economics

UNKNOWN

Sponsor Role collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Pillebout E, Durand-Zaleski I, Farge L, Perrier L, de Chaisemartin C, Dupont JCK, Behaghel L, Rochaix L; Paris School of Economics and AP-HP Hospinnomics, Paris, France. Multicentre, randomised, economic evaluation of a web-based interactive education platform, simple or enhanced, for patients with end-stage renal disease: the PIC-R trial protocol. BMJ Open. 2022 Dec 9;12(12):e062613. doi: 10.1136/bmjopen-2022-062613.

Reference Type DERIVED
PMID: 36600325 (View on PubMed)

Other Identifiers

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*P150958

Identifier Type: -

Identifier Source: org_study_id

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