Symptom Monitoring for Chronic Kidney Disease

Overseen By Kendra Wulczyn, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Terminal illness, Dialysis, Transplant, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring symptoms in people with advanced chronic kidney disease (CKD). It employs an electronic patient-reported outcome measure (ePROM) system, allowing patients to regularly report symptoms, which are then shared with their doctors. The goal is to improve communication and address symptoms more effectively, potentially enhancing patients' quality of life. Individuals with advanced CKD who see a nephrologist at Mass General Brigham might be suitable candidates. Participants should not be on dialysis or scheduled for a kidney transplant soon. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly improve patient care and communication.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for symptom monitoring in chronic kidney disease?

Research has shown that electronic tools for reporting symptoms are generally safe for people with chronic kidney disease (CKD). In past studies, patients with advanced CKD used these tools to share symptoms from home. This method proved easy to use and enhanced communication with healthcare providers. No major safety issues emerged with these digital tools. They are noninvasive, requiring only a device to report symptoms. This approach seems to be a safe and effective way to manage symptoms and improve the quality of life for CKD patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the electronic patient-reported outcome measure (ePROM) for chronic kidney disease because it offers a more structured and proactive approach to symptom monitoring compared to the usual care. Unlike traditional methods where symptom reporting is often inconsistent and depends on patient-clinician discussions, ePROM allows patients to regularly report symptoms electronically, ensuring more reliable data. This system not only keeps track of symptoms more systematically but also provides clinicians with timely feedback and guidance on symptom management, which can lead to better patient outcomes. By streamlining communication and symptom management, ePROM has the potential to transform how chronic kidney disease symptoms are monitored and addressed.

What evidence suggests that this ePROM intervention is effective for symptom monitoring in chronic kidney disease?

Research has shown that electronic tools for symptom reporting can help people with chronic kidney disease (CKD) manage their symptoms more effectively. In this trial, participants in the electronic patient-reported outcome measure (ePROM) intervention arm will regularly report CKD-related symptoms using an electronic version of the Integrated Patient Outcome Scale (IPOS)-Renal survey. Studies have found that these tools improve communication between patients and doctors, facilitating symptom management. For those with advanced CKD, regular use of these tools has been linked to better health and quality of life. This method allows frequent symptom reporting, enabling doctors to provide timely advice, which leads to improved care. Early evidence suggests that these electronic tools offer a promising way to enhance the well-being of people living with CKD. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced chronic kidney disease who experience a significant burden of symptoms affecting their quality of life. The study aims to include patients who can provide monthly reports on their health status using an electronic questionnaire.

Inclusion Criteria

Able to provide consent to participate in the study

Able to read and write in English

Under the care of a nephrologist at a Mass General Brigham nephrology clinic

Exclusion Criteria

Terminal illness likely to lead to death within 6 months of participation

Patients having their initial clinic visit (i.e., new to the clinic)

I am currently on dialysis or will start within 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants report CKD-related symptoms monthly using the electronic IPOS-Renal questionnaire with supported clinician follow-up

12 months

Monthly reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Electronic patient-reported outcome measure (ePROM)

Trial Overview The trial is testing the use of an electronic patient-reported outcome measure (ePROM) called IPOS-Renal for regular symptom monitoring in CKD patients. It compares routine reporting with feedback to nephrologists against standard care over a period of 12 months.

How Is the Trial Designed?

Group I: Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment Active Control 1 Intervention

The ePROM intervention consists of: 1) Patient reporting of CKD-related symptoms at regular intervals using an electronic version of the Integrated Patient Outcome Scale (IPOS)-Renal survey; 2) Feedback of patient responses to clinicians, and 3) Provision of guidance for symptom management to clinicians. Patients randomized to the ePROM intervention will be asked to complete monthly reporting of CKD-associated symptoms.

Group II: Usual Care Active Control 1 Intervention

For patients randomized to Usual Care, there will be no study-driven changes to existing clinical practices for patient symptom reporting or clinician follow-up of patient-reported symptoms. Usual care symptom monitoring consists of patients and clinicians discussing symptoms at their own discretion. Under usual care, no symptom guidance documents or patient symptom reports are provided to clinicians.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9395843/

Electronic patient-reported outcomes in chronic kidney ... Data on ePROs offer unique insights: in clinical trials they can provide valuable evidence on the efficacy and tolerability of treatments and in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0270929524000901

Electronic Collection of Patient-Reported Outcomes to ... We define kidney ePRO systems as ambulatory, noninvasive digital technologies that enable people with kidney disease to report and record PRO data ...

3. ajkd.org ajkd.org/article/S0272-6386(23)00892-2/abstract

Patient-Reported Outcome Measures for Patients With CKD Patient-reported outcome measures (PROMs) assess symptom severity; physical, psychological, social, and cognitive functioning; treatment-related side effects; ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/8/10/e026080

Use of an electronic patient-reported outcome measure in ... Routine remote use of ePROM data by patients with advanced CKD may aid self-management, while also helping to improve the flow of information between patients ...

5. jpro.springeropen.com jpro.springeropen.com/articles/10.1186/s41687-020-00223-8

Development of an electronic patient-reported outcome ... Routine ePROM collection and real-time feedback in patients with advanced CKD has the potential to improve outcomes and reduce health service ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7343684/

Development of an electronic patient-reported outcome ... We have successfully developed an ePROM system which allows patients with advanced CKD to remotely self-report their symptoms using a simple and ...

7. ajkd.org ajkd.org/article/S0272-6386(19)30613-4/abstract

Patient and Clinician Perspectives on Electronic ... Electronic patient-reported outcome measures (ePROMs) may capture symptoms and health-related quality of life and assist in the management of ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2017.00254/full

Patient-Reported Outcomes in Patients with Chronic ... Patient-reported outcome measures are important tools that can be used to support patient-centered care and patient engagement during the complex management of ...