Dialysis Related ComplicationPHOSFO_OKNCT05389826
mHealth for Phosphorus Management in CKD.
A study testing mHealth App in people with Dialysis Related Complication, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis Related Complication
- What is being tested?
- mHealth App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1- Eligible patients will be stage 4-5 CKD patients, including end-stage renal disease (ESRD) on dialysis, aged >18 with hyperphosphatemia (serum phosphorus concentration >1.94 mmol/L) and stable dose of phosphate binders for >1 month before screening.
Who cannot join
- Patients with intact parathyroid hormone concentration >800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.
- Patients with significant gastro-intestinal (GI) or hepatic disorders.
- Patients with major GI surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.
The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Such environment will allow nephrologists to inform patients beyond their traditional point-of-care and will allow patients to provide feedback on their condition in a timely manner that benefits the CKD collective. In this way we delve in a technological area that has been argued that remains underutilized within nephrology (1) and that should be perceived as an opportunity for CKD (2). In our work, we will build from recent related efforts in the control of hyperphosphatemia (3).
Read the detailed description
The working hypotheses are listed as follows:
- Hyperphosphatemia is an important problem in the CKD realm, but difficult to manage because patients are often not aware of its importance. In addition, current clinical practice does not allow nephrologists to evaluate the patient's real understanding of their recommendations.
- The patient could benefit from a smartphone-based interactive virtual assistant tool: an integrated personalized management system to achieve a form of participatory, personalized, predictive and preventive medicine in the specific domain of a pathology associated to CKD.
- The combination of a flexible information channel with an interactive data visualization tool on mobile devices can be a most intuitive way to communicate with the patient, particularly if it allows comparison with other patients in similar situation. Additionally, data visualization can assist nephrologists in the clinical management of patients.
Primary Objective:
1-Analysis of the superiority of a Medical Mobile Application for Patient Support to educate CKD patients on how to self-manage their phosphate levels versus standard of care in lowering serum phosphorus by assessing changes in serum phosphorus comparing baseline with 6-months follow-up.
Secondary Objectives:
- Adherence to treatment with phosphate binders.
- Impact in Quality of Life of patients with CKD.
- Satisfaction of such a tool.
- Conditions
- Dialysis Related Complication
- Being tested
- mHealth App
- Keywords
- mHealth, Hyperphosphatemia
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth AppDevice
We will compare the degree of improvement in phosphate control with respect to baseline values and report any adverse event. Nephrologist will use a web management system to provide results of phosphorus levels and medical recommendations to the patient, mediated by a cloud IT environment. In addition, patients will receive alerts, suggestions, and general information. They will also be able to communicate with nephrologists and interact with their corresponding group of fellow patients.
| Study group | Role | What they receive |
|---|---|---|
| mHealth App group | Experimental | Patients will be followed with the developed mobile web app, Receives: Device: mHealth App |
| Control | No intervention | Patients will be treated according to the current clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus
Reduction of serum phosphorus by more than 0.5 mmol/L versus the standard of care testing.
Measured: 6-months follow-up
Secondary outcomes (3)
Adherence to phosphate binder's use and reduction in their use.
The ratio of current phosphate binders that the patient is swallowing compared to the number prescribed.
Measured: 6-months follow-up
Quality of life improvement
Health-related quality of life (HRQoL) will be assessed with the Short-Form 12 questionnaire (SF-12).
Measured: 6-months follow-up
Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention
Satisfaction of patients will be assessed with the quality of care satisfaction in outpatient consultation questionnaire (EQS-C).
Measured: 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dialysis Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study involving cases and controls. Fifty outpatient patients with stage 4-5 CKD, including those on dialysis will be included. Twenty-five patients will be followed with the developed mobile web app, while another twenty-five patients will be treated according to the current clinical practice. Patients will be randomized blindly 1:1 to the study group or to the control group. The randomization technique consists of consecutively numbered sealed envelopes on which the signed group is written.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Principal investigator, MIGUEL HUESO VAL, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389826
- Sponsor's protocol ID
- PR291/21
- Acronym
- PHOSFO_OK
- Status last verified
- Sep 2023
- First submitted
- 13 May 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reporting the study design
Publications
Stauss M, Dhaygude A, Ponnusamy A, Myers M, Woywodt A. Remote digital urinalysis with smartphone technology as part of remote management of glomerular disease during the SARS-CoV-2 virus pandemic: single-centre experience in 25 patients. Clin Kidney J. 2021 Dec 21;15(5):903-911. doi: 10.1093/ckj/sfab286. eCollection 2022 May.
PubMed 35498887Topf JM, Hiremath S. Got CKD? There's an App for That! Clin J Am Soc Nephrol. 2019 Apr 5;14(4):491-492. doi: 10.2215/CJN.02350219. Epub 2019 Mar 21. No abstract available.
PubMed 30898874Chiang YC, Chang YP, Lin SC, Lin C, Hsu PH, Hsu YJ, Wu TJ. Effects of Individualized Dietary Phosphate Control Program With a Smartphone Application in Hemodialysis Patients in Taiwan. Biol Res Nurs. 2021 Jul;23(3):375-381. doi: 10.1177/1099800420975504. Epub 2020 Nov 28.
PubMed 33251815
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth System for the Self-control of Hyperphosphatemia in Patients With CKD.
- ClinicalTrials.gov ID
- NCT05389826
- Acronym / sponsor ID
- PHOSFO_OK / PR291/21
- Conditions
- Dialysis Related Complication
- Keywords
- mHealth, Hyperphosphatemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims to generate an mHealth environment in which CKD patients are empowered in terms of the self-management of their hyperphosphatemia pathology, while under medical supervision. Such environment will allow nephrologists to inform patients beyond their traditional point-of-care and will allow patients to provide feedback on their condition in a timely manner that benefits the CKD collective. In this way we delve in a technological area that has been argued that remains underutilized within nephrology (1) and that should be perceived as an opportunity for CKD (2). In our work, we will build from recent related efforts in the control of hyperphosphatemia (3).
Detailed description
The working hypotheses are listed as follows:
- Hyperphosphatemia is an important problem in the CKD realm, but difficult to manage because patients are often not aware of its importance. In addition, current clinical practice does not allow nephrologists to evaluate the patient's real understanding of their recommendations.
- The patient could benefit from a smartphone-based interactive virtual assistant tool: an integrated personalized management system to achieve a form of participatory, personalized, predictive and preventive medicine in the specific domain of a pathology associated to CKD.
- The combination of a flexible information channel with an interactive data visualization tool on mobile devices can be a most intuitive way to communicate with the patient, particularly if it allows comparison with other patients in similar situation. Additionally, data visualization can assist nephrologists in the clinical management of patients.
Primary Objective:
1-Analysis of the superiority of a Medical Mobile Application for Patient Support to educate CKD patients on how to self-manage their phosphate levels versus standard of care in lowering serum phosphorus by assessing changes in serum phosphorus comparing baseline with 6-months follow-up.
Secondary Objectives:
- Adherence to treatment with phosphate binders.
- Impact in Quality of Life of patients with CKD.
- Satisfaction of such a tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study involving cases and controls. Fifty outpatient patients with stage 4-5 CKD, including those on dialysis will be included. Twenty-five patients will be followed with the developed mobile web app, while another twenty-five patients will be treated according to the current clinical practice. Patients will be randomized blindly 1:1 to the study group or to the control group. The randomization technique consists of consecutively numbered sealed envelopes on which the signed group is written.
| Arm | Type | Receives |
|---|---|---|
| mHealth App group | Experimental | Device: mHealth AppPatients will be followed with the developed mobile web app, |
| Control | No intervention | –Patients will be treated according to the current clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Eligible patients will be stage 4-5 CKD patients, including end-stage renal disease (ESRD) on dialysis, aged >18 with hyperphosphatemia (serum phosphorus concentration >1.94 mmol/L) and stable dose of phosphate binders for >1 month before screening.
Key exclusion criteria (3 listed)
- Patients with intact parathyroid hormone concentration >800 ng/l (88 pmol/l) or if parathyroidectomy will be planned or expected.
- Patients with significant gastro-intestinal (GI) or hepatic disorders.
- Patients with major GI surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth AppWe will compare the degree of improvement in phosphate control with respect to baseline values and report any adverse event. Nephrologist will use a web management system to provide results of phosphorus levels and medical recommendations to the patient, mediated by a cloud IT environment. In addition, patients will receive alerts, suggestions, and general information. They will also be able to communicate with nephrologists and interact with their corresponding group of fellow patients. | Device | mHealth App group |
Primary outcome
Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus
Time frame: 6-months follow-up
Reduction of serum phosphorus by more than 0.5 mmol/L versus the standard of care testing.
3 secondary outcomes
Adherence to phosphate binder's use and reduction in their use.
Time frame: 6-months follow-up
Quality of life improvement
Time frame: 6-months follow-up
Patient's and healthcare professionals' satisfaction with mobile health app to ensure its usability and promote patient retention
Time frame: 6-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 35498887Stauss M, Dhaygude A, Ponnusamy A, Myers M, Woywodt A. Remote digital urinalysis with smartphone technology as part of remote management of glomerular disease during the SARS-CoV-2 virus pandemic: single-centre experience in 25 patients. Clin Kidney J. 2021 Dec 21;15(5):903-911. doi: 10.1093/ckj/sfab286. eCollection 2022 May.
- Background: PubMed 30898874Topf JM, Hiremath S. Got CKD? There's an App for That! Clin J Am Soc Nephrol. 2019 Apr 5;14(4):491-492. doi: 10.2215/CJN.02350219. Epub 2019 Mar 21. No abstract available.
- Background: PubMed 33251815Chiang YC, Chang YP, Lin SC, Lin C, Hsu PH, Hsu YJ, Wu TJ. Effects of Individualized Dietary Phosphate Control Program With a Smartphone Application in Hemodialysis Patients in Taiwan. Biol Res Nurs. 2021 Jul;23(3):375-381. doi: 10.1177/1099800420975504. Epub 2020 Nov 28.
- Individual participant dataSharing planned: Yes. Reporting the study design
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth App in people with Dialysis Related Complication, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the superiority of mobile-app and benchmarking versus standard of care in lowering serum phosphorus (time frame: 6-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389826, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.