Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT03842293
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of PROMIS in CKD
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal change in sleep disturbance', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 8 items from PROMIS sleep-related disturbance domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in sleep-related impairment', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 4 items from PROMIS sleep-related impairment domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in fatigue', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 8 items from PROMIS fatigue domain. Participants rate their experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in life satisfaction', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 4 items from from PROMIS life satisfaction domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in meaning and purpose', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 4 items from from PROMIS meaning and purpose domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in psychological stress experiences', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': 'Child self-report of 4 items from from PROMIS psychological stress experiences domain. Participants rate their experience using a five point scale ranging from not at all to quite a bit. Answers are converted to a t-score to compare to the general population.'}, {'measure': 'Longitudinal change in global health', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': "Parent proxy report of 7 items from from PROMIS global health domain. Parents rate their child's experience using a five point scale ranging from poor to excellent. Answers are converted to a t-score to compare to the general population."}, {'measure': 'Longitudinal change in depressive symptoms', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': "Parent proxy report of 4 items from from PROMIS emotional distress - depressive symptoms domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population."}, {'measure': 'Longitudinal change in anxiety', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': "Parent proxy report of 4 items from from PROMIS emotional distress - anxiety domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population."}, {'measure': 'Longitudinal change in positive affect', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': "Parent proxy report of 4 items from from PROMIS positive affect domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population."}, {'measure': 'Longitudinal change in family relationships', 'timeFrame': 'Baseline and 3 month, 6 month, 12 month, 15 month, 18 month and 24 month follow-ups.', 'description': "Parent proxy report of 4 items from from PROMIS family relationships domain. Parents rate their child's experience using a five point scale ranging from never to always. Answers are converted to a t-score to compare to the general population."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical validity of a set of PROMIS pediatric person-reported outcome measures in patients with chronic kidney disease. The evaluation includes longitudinal assessments of how measures change in association with clinical changes.', 'detailedDescription': 'The National Institutes of Health (NIH)-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) network has developed over 20 pediatric instruments, both child-report and parent-proxy editions. Cross-sectional evaluations of the validity of the instruments have established that they are ready for integration into clinical research and practice. The next step in their ongoing evaluation is to assess their prospective clinical validity in a variety of health conditions. This study addresses the clinical evaluation of the measures in children with chronic kidney disease (CKD).\n\nThrough baseline surveys and six follow-up surveys over a two-year period, Investigators are collecting self-report (child) and parent-proxy report of 11 pediatric PROMIS measures. Each of these PROMIS measures is described in the Main Outcome Measures section. Investigators are also collecting assessments of disease activity from clinical data. The selection of self-report and parent proxy patient-reported outcome (PRO) measures were determined through qualitative content validation. The analytic goal of this project is to evaluate baseline (cross-sectional) and longitudinal associations between PROMIS pediatric outcome measures and changes in the clinical status of patients with CKD. Our primary hypothesis is that as kidney function declines, self-reported health will worsen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants were initially recruited through an existing study, the Chronic Kidney Disease in Children (CKiD) study. CKiD is a long-term prospective cohort study that currently follows 364 children with CKD from 54 North American centers. Recruitment was expanded to also enroll children between the ages of 8 and 21 years who had been seen at a nephrology clinic at two CKiD participating sites, Children's Hospital of Philadelphia (CHOP) and Cincinnati Children's Hospital and Medical Center (CCHMC) and had two eGFR readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (eGFR of this level indicates CKD).", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child is 8-21 years old at time of enrollment\n* Child is a Chronic Kidney Disease in Children (CKiD) patient OR a child who receives pediatric nephrology care at a CKiD site that participates in PEDSnet, a national pediatric learning health system\n* Child seen by a pediatric nephrologist in the past 24 months\n* Child has two eGFR readings (computed from serum creatinine) between 6-89 ml/min at least 3 months apart (eGFR of this level indicates CKD)\n* Child speaks English\n* Parent is the parent or legal guardian for the child\n* Parent speaks English\n\nExclusion Criteria:\n\n* Child is currently receiving dialysis\n* Child received a kidney transplant\n* Child has a parent-reported cognitive limitation that would preclude them from completing a questionnaire\n* Child does not speak English\n* Parent does not speak English\n* Parent is not the parent of legal guardian for the child'}, 'identificationModule': {'nctId': 'NCT03842293', 'briefTitle': 'Clinical Evaluation of PROMIS in CKD', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Clinical Evaluation of PROMIS Pediatric Person Reported Outcome Measures in Children With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '17-013723'}, 'secondaryIdInfos': [{'id': '1U19AR069525', 'link': 'https://reporter.nih.gov/quickSearch/1U19AR069525', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': "Johns Hopkins Children's Center", 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, Mott Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital and Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hopsital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'MB R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': "Children's Hospital Research Institute of Manitoba", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Susan Furth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}