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| Name | Class |
|---|---|
| Centre Leon Berard | OTHER |
| Université Montpellier | OTHER |
| Telecom Bretagne | UNKNOWN |
| Paris School of Economics |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | treatment as usual will be provided to patients | |
| app-based therapeutic education | Active Comparator | patients will have access to the app providing information of the disease as well as educational guidelines |
|
| enhanced app-based therapeutic education | Experimental | patients will also have access to a chat room and discussion forum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| app-based therapeutic education | Behavioral | Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| cost utility, efficiency, budget impact | incremental cost utility ratio | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | percent of patients alive at 18 months | 18 months |
| compliance and persistence | percent of patients using the app at 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36600325 | Derived | 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. |
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JPAL plans to share the de-identified patient database
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| OTHER |
| Ministry of Health, France | OTHER_GOV |
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| enhanced app-based therapeutic education | Behavioral | Patients in the enhanced app group will also have access to a social network. (forum, chat room) |
|
| 18 months |
| disease knowledge | answers to a questionnaire and change in the number of correct answers | 18 months |
| lifestyle | changes in risk factors | 18 months |
| app utilization by professionals and patients | number of connections, shares, likes | 18 months |
| health care delivery organization | number of interactions (chats) between healthcare professionals and patients | 18 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |