Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

NCT07186218 | Not Yet Recruiting

• 2 other identifiers: 2024p0022761K23DK140642-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Health Related Quality of Life; Chronic Kidney Disease (Stages 4 and 5)

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Reach (Implementation); Screen-eligibility

  Percent of screen-eligible patients from pool of patients with advanced CKD screened for eligibility.

  Baseline

• Reach (Implementation); Rate of consenting

  Percent of screen-eligible patients approached to participate in study who provide consent to participate

  Baseline

• Feasibility (Implementation); symptom survey completion rate

  Rate of completion of electronic symptom questionnaires by participants

  Duration of active 12-month study participation

• Feasibility (Implementation); Symptom documentation

  Frequency of symptom documentation by clinicians in the clinical visit note for participants

  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.

  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.

  3-12 months of participation

Secondary Outcomes (4)

• Progression to End-Stage Kidney Disease

  Duration of active 12-month study participation plus 12 months; 24 months total

• Emergency Room Visits

  Duration of active 12-month study participation plus 12 months; 24 months total

• Hospitalizations

  Duration of active 12-month study participation plus 12 months; 24 months total

• Mortality

  Duration of active 12-month study participation plus 12 months; 24 months total

Other Outcomes (3)

• Health-Related Quality of Life: Kidney Summary Score (Preliminary Efficacy)

  Baseline, 6 months, 12 months

• Health-related quality of life: Physical (Preliminary Efficacy)

  Baseline, 6 months, 12 months

• Health-Related Quality of Life: Mental (Preliminary Efficacy)

  Baseline, 6 months, 12 months

Study Arms (2)

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.

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.

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kendra Wulczyn, MD, MPH

CONTACT

617-726-5050; kwulczyn@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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).

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)