Chronic Kidney Disease (Stages 4 and 5)NCT07186218
Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease
A study testing Electronic patient-reported outcome measure (ePROM) for symptom monitoring in people with Chronic Kidney Disease (Stages 4 and 5) and Health Related Quality of Life, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Patient-reported outcome measures (PROMs) are validated tools to reliably measure outcomes highly prioritized by patients, such as health-related quality of life (HRQOL) and symptoms, but the current clinical impact of PROMs is limited by a lack of evidence-based methods to incorporate them into routine care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5), Health Related Quality of Life
- What is being tested?
- Electronic patient-reported outcome measure (ePROM) for symptom monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (age ≥ 18 years)
- Advanced CKD, defined as at least two measurements of creatinine-based or cystatin C-based eGFR ≤ 30 mL/min/1.73m2 separated by at least 90 days in the preceding 12 months
- 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
Who cannot join
- Terminal illness likely to lead to death within 6 months of participation
- Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks
- Patients scheduled to receive a kidney transplant in the next 6 months
- Patients having their initial clinic visit (i.e., new to the clinic)
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham
Boston, Massachusetts, 02114
Kendra Wulczyn, MD, MPH, 617-726-5050, kwulczyn@mgb.org
Kendra Wulczyn, MD, MPH
About this study
Official title: Use of an Electronic Patient-Reported Outcome Measure for Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease
Patient-reported outcome measures (PROMs) are validated tools to reliably measure outcomes highly prioritized by patients, such as health-related quality of life (HRQOL) and symptoms, but the current clinical impact of PROMs is limited by a lack of evidence-based methods to incorporate them into routine care. Symptoms, which are highly prevalent among persons living with chronic kidney disease (CKD), substantially contribute to the reduced HRQOL experienced by this patient population. HRQOL spans several domains of wellbeing affected by disease, including physical, mental, and social health, functionality, and symptoms. Both HRQOL and symptom burden are consistently identified by patients with CKD as top clinical and research priorities. These issues are particularly salient to individuals living with advanced CKD, who suffer significant symptom burden that is often underrecognized and undertreated by nephrology providers, yet is a key factor considered by nephrologists for the timing of dialysis initiation. Randomized controlled trials of patients with other chronic illnesses show that routine assessment of symptoms with PROMs improves symptom burden, patient-provider communication, and HRQOL; yet, standardized approaches to regular symptom monitoring among patients with advanced CKD are lacking. This pilot, randomized trial of a PROM-based intervention for routine symptom reporting by patients with feedback of responses to nephrologists aims to address the lack of data on PROM use for symptom assessment in nephrology care. We will evaluate the implementation (reach, feasibility, and acceptability) and preliminary efficacy of monthly patient report of CKD-related symptoms using the electronic IPOS-Renal questionnaire with supported clinician follow-up for 12 months versus standard of care. This trial will utilize complementary quantitative and qualitative methods to evaluate the implementation of the PROM-based intervention. The results of this pilot study will inform a definitive, cluster-randomized trial on the effect of a PROM-based symptom assessment intervention to improve HRQOL and clinical outcomes among patients living with advanced CKD.
Read the detailed description
This is a single-center, open-label, two-arm, randomized pilot trial of 70 individuals with advanced chronic kidney disease (CKD; eGFR<20 mL/min/1.73 m2). This pilot study will assess reach, feasibility, acceptability (implementation) and preliminary efficacy of patient use of IPOS-Renal (Integrated Patient Outcome Scale-Renal, primary exposure of interest), an instrument designed to assess symptoms among patients with CKD, which will be electronically completed monthly for 12 months. Randomization will occur in a 1:1 ratio at the level of the individual; therefore, 35 individuals will be randomized to the IPOS-Renal electronic patient-reported outcome measure (ePROM) intervention arm, and 35 individuals will be randomized to the control arm (standard of care).
The ePROM intervention has three core components: 1) patient self-reporting of CKD-related symptoms at regular intervals using 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 arm will receive instruction on how to self-report symptoms using an electronic version of the IPOS-Renal instrument. Clinicians will be provided instruction on how to view patient symptom responses and given guidance regarding symptom management strategies; however, treatment decisions will be left entirely to the discretion of the clinician. Whenever a patient has a clinic visit, a symptom report will be generated and printed by the research team and will be given to the treating nephrologist.
All participants will complete two PROMs over the course of participation. At baseline, participants will complete the Kidney Disease Quality of Life-36 (KDQOL) instrument (primary efficacy outcome) and the IPOS-Renal to assess symptom burden at baseline. Participants will be given a choice to complete questionnaires online, via mailed paper forms, or over the telephone. The KDQOL questionnaire will be completed at baseline and months 6 and 12 (+/- 4 weeks each). All study questionnaires will be available in English. Chart abstraction will be conducted by a member of the study team at baseline, 3, 6, 9, and 12 months (+/- 1 months each) to collect demographic and clinical data. Additional information on clinical events (progression to CKD requiring kidney replacement therapy, emergency room visits, hospitalizations, and death) will be abstracted at 24 months. Patient and clinician participants (target n=20 patients and n=10 clinicians) will be invited to participate in semi-structured interviews for qualitative data collection. Qualitative data will be used to explore patient and clinician perspectives on symptom management in the ambulatory nephrology setting and the feasibility and acceptability of the ePROM intervention.
- Being tested
- Electronic patient-reported outcome measure (ePROM) for symptom monitoring
- Keywords
- chronic kidney disease, health related quality of life, patient-reported outcome measure, chronic kidney disease associated symptoms
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic patient-reported outcome measure (ePROM) for symptom monitoringBehavioural
Patients randomized to the ePROM intervention arm will be asked to complete monthly reporting of their CKD-associated symptoms using an electronic version of the Integrated Patient Outcome Scale (IPOS)-Renal survey. Their responses will be provided in summary form to their nephrology clinicians at regular intervals and prior to any nephrology clinic visits. Clinicians will be provided with guidance on symptom management and will have the option to participate in an informational session on how to interpret patient symptom responses.
| Study group | Role | What they receive |
|---|---|---|
| Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment | Active comparator | 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. Receives: Behavioral: Electronic patient-reported outcome measure (ePROM) for symptom monitoring |
| Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach (Implementation); Screen-eligibility
Percent of screen-eligible patients from pool of patients with advanced CKD screened for eligibility.
Measured: Baseline
Reach (Implementation); Rate of consenting
Percent of screen-eligible patients approached to participate in study who provide consent to participate
Measured: Baseline
Feasibility (Implementation); symptom survey completion rate
Rate of completion of electronic symptom questionnaires by participants
Measured: Duration of active 12-month study participation
Feasibility (Implementation); Symptom documentation
Frequency of symptom documentation by clinicians in the clinical visit note for participants
Measured: Duration of active 12-month study participation
Feasibility (Implementation); Interviews
Clinician and patient participant answers to interview questions regarding the extent to which the ePROM intervention fits within the ambulatory nephrology setting.
Measured: 3-12 months of participation
Acceptability (Implementation); Interviews
Clinician and patient participant answers to interview questions regarding satisfaction with and acceptability of the ePROM intervention.
Measured: 3-12 months of participation
Secondary outcomes (4)
Progression to End-Stage Kidney Disease
Rate of progression to end-stage kidney disease requiring kidney replacement therapy (i.e., initiation of dialysis treatment or receipt of a preemptive kidney transplant)
Measured: Duration of active 12-month study participation plus 12 months; 24 months total
Emergency Room Visits
Rate of visits to the Emergency Room
Measured: Duration of active 12-month study participation plus 12 months; 24 months total
Hospitalizations
Hospitalization rate
Measured: Duration of active 12-month study participation plus 12 months; 24 months total
Mortality
Mortality rate
Measured: Duration of active 12-month study participation plus 12 months; 24 months total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start11 Jun 2026
- Primary completionJul 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a single-center, open-label, randomized pilot trial examining the implementation and preliminary efficacy of an electronic PROM (ePROM) for routine symptom assessment with feedback of responses to clinicians among adults living with advanced CKD (eGFR \<30 mL/min/1.73m2). Patients will be assigned to either the ePROM group (35 patients) or the Usual Care group (35 patients).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendra Wulczyn, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186218
- Sponsor's protocol ID
- 2024p002276
- Other IDs
- 1K23DK140642-01A1
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Electronic Patient-Reported Outcome Measure for Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07186218
- Acronym / sponsor ID
- 2024p002276
- Keywords
- chronic kidney disease, health related quality of life, patient-reported outcome measure, chronic kidney disease associated symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 22 Sep 2025 (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.
Patient-reported outcome measures (PROMs) are validated tools to reliably measure outcomes highly prioritized by patients, such as health-related quality of life (HRQOL) and symptoms, but the current clinical impact of PROMs is limited by a lack of evidence-based methods to incorporate them into routine care. Symptoms, which are highly prevalent among persons living with chronic kidney disease (CKD), substantially contribute to the reduced HRQOL experienced by this patient population. HRQOL spans several domains of wellbeing affected by disease, including physical, mental, and social health, functionality, and symptoms. Both HRQOL and symptom burden are consistently identified by patients with CKD as top clinical and research priorities. These issues are particularly salient to individuals living with advanced CKD, who suffer significant symptom burden that is often underrecognized and undertreated by nephrology providers, yet is a key factor considered by nephrologists for the timing of dialysis initiation. Randomized controlled trials of patients with other chronic illnesses show that routine assessment of symptoms with PROMs improves symptom burden, patient-provider communication, and HRQOL; yet, standardized approaches to regular symptom monitoring among patients with advanced CKD are lacking. This pilot, randomized trial of a PROM-based intervention for routine symptom reporting by patients with feedback of responses to nephrologists aims to address the lack of data on PROM use for symptom assessment in nephrology care. We will evaluate the implementation (reach, feasibility, and acceptability) and preliminary efficacy of monthly patient report of CKD-related symptoms using the electronic IPOS-Renal questionnaire with supported clinician follow-up for 12 months versus standard of care. This trial will utilize complementary quantitative and qualitative methods to evaluate the implementation of the PROM-based intervention. The results of this pilot study will inform a definitive, cluster-randomized trial on the effect of a PROM-based symptom assessment intervention to improve HRQOL and clinical outcomes among patients living with advanced CKD.
Detailed description
This is a single-center, open-label, two-arm, randomized pilot trial of 70 individuals with advanced chronic kidney disease (CKD; eGFR<20 mL/min/1.73 m2). This pilot study will assess reach, feasibility, acceptability (implementation) and preliminary efficacy of patient use of IPOS-Renal (Integrated Patient Outcome Scale-Renal, primary exposure of interest), an instrument designed to assess symptoms among patients with CKD, which will be electronically completed monthly for 12 months. Randomization will occur in a 1:1 ratio at the level of the individual; therefore, 35 individuals will be randomized to the IPOS-Renal electronic patient-reported outcome measure (ePROM) intervention arm, and 35 individuals will be randomized to the control arm (standard of care).
The ePROM intervention has three core components: 1) patient self-reporting of CKD-related symptoms at regular intervals using 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 arm will receive instruction on how to self-report symptoms using an electronic version of the IPOS-Renal instrument. Clinicians will be provided instruction on how to view patient symptom responses and given guidance regarding symptom management strategies; however, treatment decisions will be left entirely to the discretion of the clinician. Whenever a patient has a clinic visit, a symptom report will be generated and printed by the research team and will be given to the treating nephrologist.
All participants will complete two PROMs over the course of participation. At baseline, participants will complete the Kidney Disease Quality of Life-36 (KDQOL) instrument (primary efficacy outcome) and the IPOS-Renal to assess symptom burden at baseline. Participants will be given a choice to complete questionnaires online, via mailed paper forms, or over the telephone. The KDQOL questionnaire will be completed at baseline and months 6 and 12 (+/- 4 weeks each). All study questionnaires will be available in English. Chart abstraction will be conducted by a member of the study team at baseline, 3, 6, 9, and 12 months (+/- 1 months each) to collect demographic and clinical data. Additional information on clinical events (progression to CKD requiring kidney replacement therapy, emergency room visits, hospitalizations, and death) will be abstracted at 24 months. Patient and clinician participants (target n=20 patients and n=10 clinicians) will be invited to participate in semi-structured interviews for qualitative data collection. Qualitative data will be used to explore patient and clinician perspectives on symptom management in the ambulatory nephrology setting and the feasibility and acceptability of the ePROM intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a single-center, open-label, randomized pilot trial examining the implementation and preliminary efficacy of an electronic PROM (ePROM) for routine symptom assessment with feedback of responses to clinicians among adults living with advanced CKD (eGFR <30 mL/min/1.73m2). Patients will be assigned to either the ePROM group (35 patients) or the Usual Care group (35 patients).
| Arm | Type | Receives |
|---|---|---|
| Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment | Active comparator | Behavioral: Electronic patient-reported outcome measure (ePROM) for symptom monitoringThe 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. |
| Usual Care | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age ≥ 18 years)
- Advanced CKD, defined as at least two measurements of creatinine-based or cystatin C-based eGFR ≤ 30 mL/min/1.73m2 separated by at least 90 days in the preceding 12 months
- 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
Key exclusion criteria (5 listed)
- Terminal illness likely to lead to death within 6 months of participation
- Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks
- Patients scheduled to receive a kidney transplant in the next 6 months
- Patients having their initial clinic visit (i.e., new to the clinic)
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires
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 |
|---|---|---|
| Electronic patient-reported outcome measure (ePROM) for symptom monitoringPatients randomized to the ePROM intervention arm will be asked to complete monthly reporting of their CKD-associated symptoms using an electronic version of the Integrated Patient Outcome Scale (IPOS)-Renal survey. Their responses will be provided in summary form to their nephrology clinicians at regular intervals and prior to any nephrology clinic visits. Clinicians will be provided with guidance on symptom management and will have the option to participate in an informational session on how to interpret patient symptom responses. | Behavioural | Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment |
Primary outcome
Reach (Implementation); Screen-eligibility
Time frame: Baseline
Percent of screen-eligible patients from pool of patients with advanced CKD screened for eligibility.
Reach (Implementation); Rate of consenting
Time frame: Baseline
Percent of screen-eligible patients approached to participate in study who provide consent to participate
Feasibility (Implementation); symptom survey completion rate
Time frame: Duration of active 12-month study participation
Rate of completion of electronic symptom questionnaires by participants
Feasibility (Implementation); Symptom documentation
Time frame: Duration of active 12-month study participation
Frequency of symptom documentation by clinicians in the clinical visit note for participants
Feasibility (Implementation); Interviews
Time frame: 3-12 months of participation
Clinician and patient participant answers to interview questions regarding the extent to which the ePROM intervention fits within the ambulatory nephrology setting.
Acceptability (Implementation); Interviews
Time frame: 3-12 months of participation
Clinician and patient participant answers to interview questions regarding satisfaction with and acceptability of the ePROM intervention.
4 secondary outcomes
Progression to End-Stage Kidney Disease
Time frame: Duration of active 12-month study participation plus 12 months; 24 months total
Emergency Room Visits
Time frame: Duration of active 12-month study participation plus 12 months; 24 months total
Hospitalizations
Time frame: Duration of active 12-month study participation plus 12 months; 24 months total
Mortality
Time frame: Duration of active 12-month study participation plus 12 months; 24 months total
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic patient-reported outcome measure (ePROM) for symptom monitoring in people with Chronic Kidney Disease (Stages 4 and 5) and Health Related Quality of Life, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kendra Wulczyn, MD, MPH (617-726-5050, kwulczyn@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (Implementation); Screen-eligibility (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.