Patient mobile application for peritoneal dialysis patients: a pilot study
| ISRCTN | ISRCTN27397017 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27397017 |
| EudraCT/CTIS number | Nil Known |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | RCS2021-003 |
- Submission date
- 26/04/2022
- Registration date
- 29/04/2022
- Last edited
- 23/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Peritoneal dialysis (PD) is a type of dialysis which uses the peritoneum in a person's abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood. It is used to remove excess fluid, correct electrolyte problems, and remove toxins in those with kidney failure.
In peritoneal dialysis supported by remote monitoring programs, there are no tools for mobile applications, properly evaluated and validated, so a project that undertakes these tasks is very relevant.
The primary objective of this trial is to assess the impact on patient treatment engagement of a remote monitoring program based on a patient mobile application (PMA) compared to standard health care without the mobile application.
Who can participate?
Peritoneal dialysis (PD) patients aged between 18 and 84 years.
What does the study involve?
Participants will be randomly allocated to use the Patient Mobile Application (PMA) or receive standard care.
What are the possible benefits and risks of participating?
The expected benefits come from the fact that having more data on what is happening with the treatment at the patient's home could improve their health outcomes.
The intervention in this study, which is the use of the application for mobile devices, does not imply any risk for the patient.
Where is the study run from?
Baxter Healthcare Corporation (Colombia)
When is the study starting and how long is it expected to run for?
November 2021 to August 2023
Who is funding the study?
Baxter Healthcare Corporation (USA)
Who is the main contact?
Dr Mauricio Sanabria, mauricio_sanabria@baxter.com
Dr Javier Cely, javier_cely@baxter.com
Contact information
Principal Investigator
Calle 44 No. 59-75
Bogota DC
111321
Colombia
| Phone | +57 3003750232 |
|---|---|
| javier_cely@baxter.com |
Scientific
TV 23 No 97-73
Bogota DC
110221
Colombia
 ORCID ID |
0000-0002-5111-9832 |
|---|---|
| Phone | +57 3153663465 |
| mauricio_sanabria@baxter.com |
Study information
| Study design | Multicenter open-label randomized controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not avalilable in web format, please use contact details to request a participant information sheet. |
| Scientific title | Multicenter, open-label, randomized controlled clinical trial of prevalent peritoneal dialysis (PD) patients using the Patient Mobile Application (PMA) versus a standard care group: A pilot study. |
| Study acronym | My PD |
| Study objectives | There is a difference in the degree of patient engagement in treatment with a remote monitoring program based on an application for mobile devices, compared to patients with standard care without the application for mobile devices. |
| Ethics approval(s) | Approved 09/02/2022, Ethics research committee Fundación Cardioinfantil-La Cardio (Bogotá DC, Colombia; Calle 163A numero 13B 60; +57 6672727; eticainvestigacion@cardioinfantil.org), ref: CEIC-0028-2022 |
| Health condition(s) or problem(s) studied | Remote monitoring programm based on mobile application for patients on peritoneal dialysis. |
| Intervention | The trial contemplates a 24-week follow-up. Patients will be randomly assigned to the program with remote monitoring based on an application for mobile devices (PMA) or to standard health care (without PMA). Patients belonging to the renal clinics selected for the study who meet the inclusion criteria and do not meet the exclusion criteria will be invited to participate in the experiment, under a rigorous informed consent process. Once the patient accepts the invitation to participate, compliance with the participation criteria will be evaluated in detail, and he/she will then be randomly assigned to one of the two arms of the study. Patients assigned to the intervention arm (remote monitoring program based on a mobile device application) will be trained in the use of the application, and in the adjustments to the care plan that will be made within the remote monitoring program. Baseline assessments will be performed in both groups and follow-up will be initiated for up to 24 weeks. Randomization is performed using an online tool based on REDCap (Research Electronic Data Capture). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | My PD Remote Monitoring APP |
| Primary outcome measure | Patient/renal clinical interaction, assessed by: 1. Number of changes in dialysis prescription per patient on follow-up from the start of follow-up for up to 24 weeks. 2. Documented frequency of patient-clinic and clinic-patient communications from start of follow-up for up to 24 weeks; and 3. Number of preventive visits to the renal clinic at six (6) months follow-up. These visits are defined as those that are not the regular monthly scheduled visits, that are cited by the clinical staff, and that are intended to proactively intervene in any condition detected in the patient, will be recorded from the start of follow-up for up to 24 weeks. |
| Secondary outcome measures | Impact on clinical interventions, measured as: 1. Changes in the number of antihypertensives prescribed per patient at 24-week follow-up. 2. Number of emergency department visits per patient at six-month follow-up. 3. Number of hospitalizations per patient at six-month follow-up. 4. Health-related quality of life measured at baseline and at six months (week 24), measured with the KDQoL-36 and PROMIS-29 profile v2.1 instruments. 5. Evaluation of the usability of the cell phone application assessed with the mHealth App Interactive Usability Questionnaire (MAUQ) instrument for patients and health professionals. This evaluation will be performed in week 4 of use and only for the arm randomized to the cell phone application. |
| Overall study start date | 01/11/2021 |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 168 |
| Key inclusion criteria | 1. Patient ≥18 and ≤85 years of age. 2. Being diagnosed with chronic kidney disease with renal failure. 3. Being a prevalent PD patient (having reached day 90 in a chronic PD program) 4. Having a smart phone (patient or caregiver) that meets the conditions for installing the application (App). |
| Key exclusion criteria | 1. A patient who does not provide informed consent to participate in the study. 2. If the patient is female, pregnancy status. 3. Patients with a prescription for peritoneal dialysis due to a non-renal cause (e.g., cardiorenal). 4. Patients with cirrhosis or hepatic cancer. 5. A patient who is currently participating or has participated in a clinical trial within the last 30 days. 6. Patients with a sensory or cognitive compromise that prevents adequate interaction with the mobile device app. |
| Date of first enrolment | 15/09/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- Colombia
Study participating centres
Bogota DC
111311
Colombia
Bogota DC
110131
Colombia
Bogota DC
111321
Colombia
Bogota DC
110121
Colombia
Bucaramanga
680008
Colombia
Cali
760003
Colombia
Medellin
050015
Colombia
Sponsor information
Industry
One Baxter Parkway
Deerfield, IL
60015
United States of America
| Phone | +1 2249484744 |
|---|---|
| angelal_rivera@baxter.com |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of this study will be published in the form of a poster and a scientific article. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the patients give inform consent only for investigators of our study. |
Editorial Notes
23/01/2023: The recruitment end date was changed from 30/01/2023 to 31/03/2023.
15/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/12/2022 to 30/01/2023.
2. The overall trial end date was changed from 31/05/2023 to 31/08/2023.
3. The intention to publish date was changed from 01/11/2023 to 30/11/2023.
27/09/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2022 to 15/09/2022.
2. The recruitment end date was changed from 01/12/2022 to 15/12/2022.
22/08/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 25/08/2022 to 01/09/2022.
2. The recruitment end date was changed from 07/11/2022 to 01/12/2022.
19/08/2022: The recruitment start date has been changed from 08/08/2022 to 25/08/2022.
19/07/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2022 to 08/08/2022.
2. The recruitment end date was changed from 30/09/2022 to 07/11/2022.
28/04/2022: Trial's existence confirmed by LaCardio
