Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease
NCT ID: NCT03847766
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2018-12-03
2023-12-15
Brief Summary
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Detailed Description
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1. PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not)
2. PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient)
3. Usual outpatient follow-up visits (Patients are seen in the outpatient clinic)
The 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Patients 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.
Patients will receive 2 reminders if they do not answer the questionnaires and clinicians will call the patient
SUPPORTIVE_CARE
NONE
Study Groups
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PRO-based follow-up
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.
PRO-based follow-up
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
PRO-based telephone consultations
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.
PRO-based telephone consultation
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
Usual outpatient follow-up visits
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.
No interventions assigned to this group
Interventions
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PRO-based follow-up
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
PRO-based telephone consultation
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated Glomerular Filtration Rate (eGFR) between 10-39 mL/min 1.73m2.
* Aged ≥18 years old
* Ability to provide fully informed written consent for participation in the study
Exclusion Criteria
* Patients who, in the opinion of the consenting professional, cannot speak, read or write Danish sufficiently well to complete the PRO questionnaire unaided
* Patients with hearing disabilities
* Patients with an eGFR \> 39mL/min 1.73m2 at their first visit at the hospital
* Patients who have received (or have a scheduled date to receive) a kidney transplant
* 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
* Patients receiving chemotherapy, with end stage Chronic Obstructive Lung disease, or with heart failure with Ejection Fraction (EF)\< 15 %.
* A projected risk of progression to end-stage renal failure within 6 months, determined from albumin/creatinine ratio
18 Years
ALL
No
Sponsors
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Regional Hospital West Jutland
OTHER
Aarhus University Hospital
OTHER
TrygFonden, Denmark
INDUSTRY
Karen Elise Jensen Foundation
OTHER
Sygekassernes Helsefond
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Niels Henrik Hjollund, MD,Professor
Role: STUDY_DIRECTOR
Regional Hospital West Jutland
Birgith Grove, MHSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital & Regional Hospital West Jutland
Locations
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Birgith Engelst Grove
Herning, , Denmark
Countries
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References
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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.
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.
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.
Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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PROKID
Identifier Type: -
Identifier Source: org_study_id