Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07186218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-Related Quality of Life: Kidney Summary Score (Preliminary Efficacy)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': '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.'}, {'measure': 'Health-related quality of life: Physical (Preliminary Efficacy)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Kidney Disease Quality of Life-36 (KDQOL-36)\n\nThis 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.'}, {'measure': 'Health-Related Quality of Life: Mental (Preliminary Efficacy)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Reach (Implementation); Screen-eligibility', 'timeFrame': 'Baseline', 'description': 'Percent of screen-eligible patients from pool of patients with advanced CKD screened for eligibility.'}, {'measure': 'Reach (Implementation); Rate of consenting', 'timeFrame': 'Baseline', 'description': 'Percent of screen-eligible patients approached to participate in study who provide consent to participate'}, {'measure': 'Feasibility (Implementation); symptom survey completion rate', 'timeFrame': 'Duration of active 12-month study participation', 'description': 'Rate of completion of electronic symptom questionnaires by participants'}, {'measure': 'Feasibility (Implementation); Symptom documentation', 'timeFrame': 'Duration of active 12-month study participation', 'description': 'Frequency of symptom documentation by clinicians in the clinical visit note for participants'}, {'measure': 'Feasibility (Implementation); Interviews', 'timeFrame': '3-12 months of participation', 'description': 'Clinician and patient participant answers to interview questions regarding the extent to which the ePROM intervention fits within the ambulatory nephrology setting.'}, {'measure': 'Acceptability (Implementation); Interviews', 'timeFrame': '3-12 months of participation', 'description': 'Clinician and patient participant answers to interview questions regarding satisfaction with and acceptability of the ePROM intervention.'}], 'secondaryOutcomes': [{'measure': 'Progression to End-Stage Kidney Disease', 'timeFrame': 'Duration of active 12-month study participation plus 12 months; 24 months total', 'description': '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)'}, {'measure': 'Emergency Room Visits', 'timeFrame': 'Duration of active 12-month study participation plus 12 months; 24 months total', 'description': 'Rate of visits to the Emergency Room'}, {'measure': 'Hospitalizations', 'timeFrame': 'Duration of active 12-month study participation plus 12 months; 24 months total', 'description': 'Hospitalization rate'}, {'measure': 'Mortality', 'timeFrame': 'Duration of active 12-month study participation plus 12 months; 24 months total', 'description': 'Mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'health related quality of life', 'patient-reported outcome measure', 'chronic kidney disease associated symptoms'], 'conditions': ['Chronic Kidney Disease (Stages 4 and 5)', 'Health Related Quality of Life']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age ≥ 18 years)\n* 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\n* Able to provide consent to participate in the study\n* Able to read and write in English\n* Under the care of a nephrologist at a Mass General Brigham nephrology clinic\n\nExclusion Criteria:\n\n* Terminal illness likely to lead to death within 6 months of participation\n* Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks\n* Patients scheduled to receive a kidney transplant in the next 6 months\n* Patients having their initial clinic visit (i.e., new to the clinic)\n* Cognitive deficits that would preclude understanding of consent form and/or questionnaires'}, 'identificationModule': {'nctId': 'NCT07186218', 'briefTitle': 'Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Use of an Electronic Patient-Reported Outcome Measure for Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '2024p002276'}, 'secondaryIdInfos': [{'id': '1K23DK140642-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DK140642-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment', 'description': '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.', 'interventionNames': ['Behavioral: Electronic patient-reported outcome measure (ePROM) for symptom monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': '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': [{'name': 'Electronic patient-reported outcome measure (ePROM) for symptom monitoring', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Electronic patient-reported outcome (ePROM) intervention for routine symptom assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Kendra Wulczyn, MD, MPH', 'role': 'CONTACT', 'email': 'kwulczyn@mgb.org', 'phone': '617-726-5050'}, {'name': 'Kendra Wulczyn, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mass General Brigham', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Kendra Wulczyn, MD, MPH', 'role': 'CONTACT', 'email': 'kwulczyn@mgb.org', 'phone': '617-726-5050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Kendra Wulczyn, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}