Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT03847766
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2019-01-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With 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 randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process.\n\nPatients in the intervention arms will receive diagnosis specific questionnaires through a safe internet connection every third month. The responses are seen by the clinicians in the Electronic Health Record.\n\nPatients will receive 2 reminders if they do not answer the questionnaires and clinicians will call the patient'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline questionnaires of non-participants', 'timeFrame': 'Baseline questionnaires', 'description': 'All patients who met the inclusion criteria will be asked to fill in a questionnaire. The questionnaire will include Health Literacy (subscale 4,6,9), Selfefficacy, General Health (SF-36) and 5 renal specific symptoms (KDQOL), Patient activation (2+12), education and employment status. The purpose is to identify baseline differences between participants and non-participants and thereby testing the PRO system for generalizability.'}], 'primaryOutcomes': [{'measure': 'Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months', 'timeFrame': 'Measured at baseline, 6, 12 and 18 months after randomisation', 'description': 'Measurement for renal function'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '18 months after randomization', 'description': 'Overall mortality'}, {'measure': 'End Stage Renal Disease (ESRD)', 'timeFrame': '18 months after randomization', 'description': 'Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis'}, {'measure': 'Kidney transplantation', 'timeFrame': '18 months after randomization', 'description': 'Has the patient received a kidney transplant during follow-up'}, {'measure': 'Hospital admission', 'timeFrame': 'From baseline at 18 months after randomization', 'description': 'Difference in number of admissions'}, {'measure': 'Number of contacts', 'timeFrame': '18 months after randomization', 'description': 'Number of contacts includes all contacts with the outpatient clinic in the study follow-up period'}, {'measure': 'General Health (SF36),', 'timeFrame': 'Baseline, 6,12 and 18 months after randomization', 'description': 'General health will be assessed by items from the SF-36 questionnaire'}, {'measure': 'Illness perception (BIPQ)', 'timeFrame': 'Baseline, 6,12 and 18 months after randomization', 'description': 'Illness perception will be assessed by the Brief Illness perception questionnaire'}, {'measure': 'Quality of Life (EQ-5D)', 'timeFrame': 'Baseline, 6,12 and 18 months after randomization', 'description': 'EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention'}, {'measure': 'Satisfaction with care', 'timeFrame': '6,12,18 months after randomization', 'description': 'Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire'}, {'measure': 'Confidence', 'timeFrame': '6,12,18 months after randomization', 'description': 'Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire'}, {'measure': 'Treatment safety', 'timeFrame': '6,12,18 months after randomization', 'description': 'Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire'}, {'measure': 'Patient involvement', 'timeFrame': 'Patient involvement will be measured at 6,12 and18 months', 'description': 'Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRO-based follow-up, TelePRO', 'Outpatients, Chronic Kidney Disease'], 'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'availIpds': [{'id': '31484523', 'url': 'https://pubmed.ncbi.nlm.nih.gov/31484523/', 'type': 'Study Protocol', 'comment': 'Data can be accessed by request from the corresponding author'}], 'references': [{'pmid': '31484523', 'type': 'BACKGROUND', 'citation': 'Grove BE, Ivarsen P, de Thurah A, Schougaard LM, Kyte D, Hjollund NH. Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial. BMC Health Serv Res. 2019 Sep 4;19(1):631. doi: 10.1186/s12913-019-4461-y.'}, {'pmid': '39006159', 'type': 'DERIVED', 'citation': 'Grove BE, Schougaard LMV, Mose F, Randers E, Hjollund NH, Ivarsen P, De Thurah A. Remote symptom monitoring with patient-reported outcome measures in outpatients with chronic kidney disease (PROKID): a multicentre randomised controlled non-inferiority study. Clin Kidney J. 2024 Jun 14;17(7):sfae176. doi: 10.1093/ckj/sfae176. eCollection 2024 Jul.'}, {'pmid': '38656781', 'type': 'DERIVED', 'citation': 'Grove BE, de Thurah A, Ivarsen P, Kvisgaard AK, Hjollund NH, Grytnes R, Schougaard LMV. Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2024 Apr 24;8:e48173. doi: 10.2196/48173.'}]}, 'descriptionModule': {'briefSummary': "This randomized controlled trial (RCT) will evaluate if PRO-based follow-up is at least as effective as usual outpatient follow-up in managing decline in renal function and maintaining patients' quality of life. Furthermore, we intend to characterize the target patient group that is suitable for PRO-based follow up in a group of patients suffering from renal insufficiency.", 'detailedDescription': 'This randomized controlled trial investigates the use of Patient-reported Outcome (PRO) follow-up among patients with chronic kidney disease. Usual outpatient follow-up visits will be replaced with diagnosis-specific electronic questionnaires filled in by the patient at home. Participants in the PRO-based follow up will complete a disease specific questionnaire every 3 months. Patients with an estimated Glomerular Filtration Rate (eGFR) \\< 40mL/min are randomized into three groups of follow-up\n\n1. PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not)\n2. PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient)\n3. Usual outpatient follow-up visits (Patients are seen in the outpatient clinic)\n\nThe aim of this study is to compare the effect on the clinical outcomes, the utilisation of resources, and patient-reported outcome in three types of follow-up in a non-inferiority randomised controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to the renal care services at Aarhus University Hospital or Regional Hospital Central Jutland, Viborg\n* Estimated Glomerular Filtration Rate (eGFR) between 10-39 mL/min 1.73m2.\n* Aged ≥18 years old\n* Ability to provide fully informed written consent for participation in the study\n\nExclusion Criteria:\n\n* Patients unwilling to participate in PRO-based follow-up\n* Patients who, in the opinion of the consenting professional, cannot speak, read or write Danish sufficiently well to complete the PRO questionnaire unaided\n* Patients with hearing disabilities\n* Patients with an eGFR \\> 39mL/min 1.73m2 at their first visit at the hospital\n* Patients who have received (or have a scheduled date to receive) a kidney transplant\n* A terminal illness that, in the opinion of the consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study\n* Patients receiving chemotherapy, with end stage Chronic Obstructive Lung disease, or with heart failure with Ejection Fraction (EF)\\< 15 %.\n* A projected risk of progression to end-stage renal failure within 6 months, determined from albumin/creatinine ratio'}, 'identificationModule': {'nctId': 'NCT03847766', 'acronym': 'PROKID', 'briefTitle': 'Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study', 'orgStudyIdInfo': {'id': 'PROKID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO-based follow-up', 'description': "Patients will receive a questionnaire every 3 months. The PRO questionnaire is used as decision aid together with other available clinical data to decide whether the patient needs a visit or not. Hence, patients only visit the outpatient clinic if there is a clinical need or a patient's wish. The actual response for each questionnaire automatically results in a colour code (green, yellow or red). A red or yellow response indicates that the patient needs to be contacted. A green colour indicates no need for a visit. Based on an overview of the questionnaire and the patient's blood samples a physician decides whether this patient should have a telephone consultation or the patient needs to be seen in the clinic.", 'interventionNames': ['Behavioral: PRO-based follow-up']}, {'type': 'EXPERIMENTAL', 'label': 'PRO-based telephone consultations', 'description': 'Patients receive an electronic questionnaire every 3 months prior to a scheduled telephone consultation.The PRO questionnaire is used as dialogue support during the telephone consultation. The actual response for each item automatically results in a colour code (green, yellow or red). A red response indicates that the patient has a problem; a yellow colour indicates a potential problem, while a green colour indicates no problems.', 'interventionNames': ['Behavioral: PRO-based telephone consultation']}, {'type': 'NO_INTERVENTION', 'label': 'Usual outpatient follow-up visits', 'description': 'Patients in the control group will continue to have usual scheduled outpatient follow-up visits at the hospital initiated by the physician every 3 months. These patients do not use the clinical PRO questionnaire, but complete the research questionnaires.'}], 'interventions': [{'name': 'PRO-based follow-up', 'type': 'BEHAVIORAL', 'otherNames': ['TelePRO'], 'description': 'Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic', 'armGroupLabels': ['PRO-based follow-up']}, {'name': 'PRO-based telephone consultation', 'type': 'BEHAVIORAL', 'description': 'diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation', 'armGroupLabels': ['PRO-based telephone consultations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Birgith Engelst Grove', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}], 'overallOfficials': [{'name': 'Niels Henrik Hjollund, MD,Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regional Hospital West Jutland'}, {'name': 'Birgith Grove, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital & Regional Hospital West Jutland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional Hospital West Jutland', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}, {'name': 'Karen Elise Jensen Foundation', 'class': 'OTHER'}, {'name': 'Sygekassernes Helsefond', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}