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| Name | Class |
|---|---|
| Spanish Society of Nephrology | OTHER |
| SOMANE (MADRID SOCIETY OF NEPHROLOGY) | UNKNOWN |
| Foundation for Biomedical Research of the Hospital Universitario 12 de Octubre | UNKNOWN |
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The main goal of this study is to assess whether a mobile phone app called MiDiálisis is practical, easy to use, and well-accepted. The app was developed by the Technical University of Madrid (UPM) and is designed to bring together the clinical data of people with chronic kidney disease who are on peritoneal dialysis. This way, both patients and doctors can access the information at any time.
This is a free smartphone app that collects information in three ways:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTERVENTION | Experimental | This group will recived the smart band, smart scale and the APP |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart band | Device | During Phase 2, patients will use the smart band continuously throughout the day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and adherence | To assess the feasibility and adherence to the use of MiDiálisis among patients undergoing peritoneal dialysis (PD), defined as the number of times per week that the patient or caregiver accesses the MiDiálisis app. | The investigators analized the number of times that patient or caregiver access the MiDialisis app during 8 weeks that the patient would be installed the App in his mobile. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived quality | To assess patient and caregiver satisfaction (perceived quality, visit 4) with the use of MiDiálisis, measured using the Mobile App Rating Scale (MARS), (23 items, max. 115 points, higher scores mean a better outcome). | After 8 weeks of using mobile App (week +16 from recruitment), the patient or caregiver will filled Mobile App Rating Scale (MARS) to analized satisfaction grade. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aida Frias, MD | Contact | +34667805030 | midialisispuma@gmail.com | |
| Paula Jara Caro Espada, MD | Contact | +34646403845 | jcaroespada@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Yuste Lozano, PhD | Hospital 12 de Octubre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| Smart scale | Device | During Phase 2, patients will weigh themselves daily using the scale. |
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| MiDialisis App | Device | Patients will enter daily blood pressure data and information related to their peritoneal dialysis therapy. |
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| Patients will install the app during the phase 2. | Device | Patients will download and begin using the application. |
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| Patients will connect the digital scale. | Device | Patients will connect the digital scale to the application via Bluetooth. |
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| Patients will connect the smartband. | Device | Patients will connect the smartband to the application via Bluetooth. |
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| Usability | To assess healthcare professionals' satisfaction with the use of the MiDiálisis dashboard. the healthcare professional will filled the System Usability Scale (SUS) (10 items, max 50 points, higher scores mean a better outcome). | After 8 weeks using MiDialisis dashboard (week +16 from recruitment, visit 4). |
| In-person Clinical care | Changes in in-person clinical care, measured as the number of face-to-face visits across Phase 1, Phase 2, and Phase 3. | At the end of the study (week +24 from recruitment, visit 5). |
| telephone-based clinical care | Changes in telephone-based clinical care, measured as differences in the number of telephone calls across Phase 1, Phase 2, and Phase 3. | At the end of the study (week +24 from recruitment, visit 5). |
| unscheduled visits | Changes in the number of unscheduled visits.Measured as the number of unscheduled visits between Phase 1, Phase 2, and Phase 3. | At the end of the study (week +24 from recruitment, visit 5). |
| overall clinical care | Changes in overall clinical care. Measured as the number of interactions in the MiDiálisis chat vs. another objetives. | At the end of the study (week +24 from recruitment, visit 5). |
| Kidney Disease Quality of Life-36 | Changes in patient-reported health outcomes (PROMs) with MiDiálisis between Phase 1 and Phase 2. Measured using the Kidney Disease Quality of Life-36 (KDQOL-36) scale (36 items, max 100 points, higher scores mean a better outcome.). | At the end of the study (week +24 from recruitment, visit 5). |
| Kidney Disease and Quality of Life™ Short Form | Changes in patient-reported health experience (PREMS) with the use of MiDiálisis between Phase 1 and Phase 2. Measured with the Kidney Disease and Quality of Life™ Short Form (KDQOLSF) (24 items, quantitative, higher scores mean a better outcome). | At the end of the study (week +24 from recruitment, visit 5). |
| Pittsburgh Sleep Quality Index | Assess subjective changes in sleep quality between Phase 1 and Phase 2. Measured using the Pittsburgh Sleep Quality Index (PSQI) (19 items, max 21 points, higher scores mean a worse outcome). | At the end of the study (week +24 from recruitment, visit 5). |
| Physical Activity Questionnaire | Assess changes in physical activity between Phase 1 and Phase 2. Measured using the International Physical Activity Questionnaire (IPAQ) (7 items, quantitative, higher scores indicate higher levels of physical activity). | At the end of the study (week +24 from recruitment, visit 5). |