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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Kidney Transplantation; Dialysis; End-stage Renal Disease

Treatments: Behavioral: enhanced app-based therapeutic education; Behavioral: app-based therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT03090828

*P150958

Details and patient eligibility

About

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

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• did not fill the screening questionnaire

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 3 patient groups

control

No Intervention group

Description:

treatment as usual will be provided to patients

app-based therapeutic education

Active Comparator group

Description:

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

Treatment:

Behavioral: app-based therapeutic education

enhanced app-based therapeutic education

Experimental group

Description:

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

Treatment:

Behavioral: enhanced app-based therapeutic education