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:
University of Aarhus
Organization:
Study Overview
Official Title:
Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROKID
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: