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

  • STATUS
    Recruiting
  • End date
    Jul 10, 2023
  • participants needed
    150
  • sponsor
    University of Aarhus
Updated on 10 May 2021

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.

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.

Details
Condition Renal Failure, Chronic Kidney Diseases, Kidney Failure (Pediatric), Kidney Failure, chronic kidney disease, chronic kidney disease (ckd)
Treatment PRO-based follow-up, PRO-based telephone consultation
Clinical Study IdentifierNCT03847766
SponsorUniversity of Aarhus
Last Modified on10 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Referred to the renal care services at Aarhus University Hospital or Regional Hospital Central Jutland, Viborg
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 unwilling to participate in PRO-based follow-up
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
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