Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Kidney Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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. 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 patientMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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 PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not) PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient) 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.
Tracking Information
- NCT #
- NCT03847766
- Collaborators
- Regional Hospital West Jutland
- Aarhus University Hospital
- TrygFonden, Denmark
- Karen Elise Jensen Foundation
- Sygekassernes Helsefond
- Investigators
- Study Director: Niels Henrik Hjollund, MD,Professor Regional Hospital West Jutland Principal Investigator: Birgith Grove, MHSc Aarhus University Hospital & Regional Hospital West Jutland