Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

May 1, 2026

Status verified

Mar 2026

Primary completion

Jul 31, 2029

Completion

Feb 28, 2030

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

Reach (Implementation); Screen-eligibility [ Time Frame: Baseline ]

Central Contacts

• Kendra Wulczyn, MD, MPH
  617-726-5050
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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