Recruiting

PROMs Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT07186218

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Health Related Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic patient-reported outcome measure (ePROM) for symptom monitoring

Study Details

Brief 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. 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.

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Health Related Quality of Life

Study ID

NCT07186218

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment

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.

no intervention: Usual Care

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.

Interventions

Electronic patient-reported outcome measure (ePROM) for symptom monitoring

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.

Primary outcome measure

  • Reach (Implementation); Screen-eligibility [ Time Frame: Baseline ]
  • Reach (Implementation); Rate of consenting [ Time Frame: Baseline ]
  • Feasibility (Implementation); symptom survey completion rate [ Time Frame: Duration of active 12-month study participation ]
  • Feasibility (Implementation); Symptom documentation [ Time Frame: Duration of active 12-month study participation ]
  • Feasibility (Implementation); Interviews [ Time Frame: 3-12 months of participation ]
  • Acceptability (Implementation); Interviews [ Time Frame: 3-12 months of participation ]

Central Contacts and Locations

Central contacts

Kendra Wulczyn, MD, MPH

617-726-5050kwulczyn@mgb.org

Locations

Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kendra Wulczyn, MD, MPH

617-726-5050kwulczyn@mgb.org

Principal Investigator:

Kendra Wulczyn, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • chronic kidney disease
  • health related quality of life
  • patient-reported outcome measure
  • chronic kidney disease associated symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-22.