Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Electronic patient-reported outcome (ePROM) intervention for routine symptom assessmentActive comparator 1 intervention

Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

Reach (Implementation); Screen-eligibility

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

Time frame

Baseline

Reach (Implementation); Rate of consenting

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

Time frame

Baseline

Feasibility (Implementation); symptom survey completion rate

Rate of completion of electronic symptom questionnaires by participants

Time frame

Duration of active 12-month study participation

Feasibility (Implementation); Symptom documentation

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

Time frame

Duration of active 12-month study participation

Secondary outcomes

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)

Time frame

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

Emergency Room Visits

Rate of visits to the Emergency Room

Time frame

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

Hospitalizations

Hospitalization rate

Time frame

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

Mortality

Mortality rate

Time frame

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

Other outcomes

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

Kidney Disease Quality of Life-36 (KDQOL-36) This outcome will be assessed as change in the kidney summary score of the KDQOL-36 over 12 months. Lowest score - 0; Highest score - 100. A lower score indicates a worse outcome.

Time frame

Baseline, 6 months, 12 months

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

Kidney Disease Quality of Life-36 (KDQOL-36) This outcome will be assessed as change in the physical composite score of the KDQOL-36 over 12 months. Lowest score - 0; Highest score - 100. A lower score indicates a worse outcome.

Time frame

Baseline, 6 months, 12 months

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

Kidney Disease Quality of Life-36 (KDQOL-36) This outcome will be assessed as change in the mental composite score of the KDQOL-36 over 12 months. Lowest score - 0; Highest score - 100. A lower score indicates a worse outcome.

Time frame

Baseline, 6 months, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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