NCT03847766

Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease

Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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-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 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

• Chronic Kidney Diseases

Interventions

Type	Name	Description
BEHAVIORAL	PRO-based follow-up	Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
BEHAVIORAL	PRO-based telephone consultation	diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation

Timeline

• Start date: 2018-12-03
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2019-02-20
• Last updated: 2023-12-22

Locations

1 site across 1 country: Denmark