Dialysis, End-stage Renal Disease, Kidney Transplantation
Conditions
Keywords
economic evaluation, e health
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
Interventions
BEHAVIORALapp-based therapeutic education
Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
BEHAVIORALenhanced app-based therapeutic education
Patients in the enhanced app group will also have access to a social network. (forum, chat room)
Sponsors
Centre Leon Berard
Université Montpellier
Telecom Bretagne
Paris School of Economics
Ministry of Health, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* severe end-stage renal disease Internet, literacy informed consent
Exclusion criteria
* did not fill the screening questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cost utility, efficiency, budget impact | 18 months | incremental cost utility ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compliance and persistence | 18 months | percent of patients using the app at 18 months |
| disease knowledge | 18 months | answers to a questionnaire and change in the number of correct answers |
| overall survival | 18 months | percent of patients alive at 18 months |
| app utilization by professionals and patients | 18 months | number of connections, shares, likes |
| health care delivery organization | 18 months | number of interactions (chats) between healthcare professionals and patients |
| lifestyle | 18 months | changes in risk factors |
Outcome results
None listed