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

University of Aarhus152 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

152

Conditions

Chronic Kidney Diseases

Interventions

PRO-based follow-upBEHAVIORAL

Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic

PRO-based telephone consultationBEHAVIORAL

diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Birgith Engelst Grove

Herning, Denmark

Outcomes

Primary Outcomes

Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months

Measurement for renal function

Time frame: Measured at baseline, 6, 12 and 18 months after randomisation

Secondary Outcomes

Mortality

Overall mortality

Time frame: 18 months after randomization

End Stage Renal Disease (ESRD)

Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis

Time frame: 18 months after randomization

Kidney transplantation

Has the patient received a kidney transplant during follow-up

Time frame: 18 months after randomization

Hospital admission

Difference in number of admissions

Time frame: From baseline at 18 months after randomization

Number of contacts

Number of contacts includes all contacts with the outpatient clinic in the study follow-up period

Time frame: 18 months after randomization

General Health (SF36),

General health will be assessed by items from the SF-36 questionnaire

Time frame: Baseline, 6,12 and 18 months after randomization

Illness perception (BIPQ)

Illness perception will be assessed by the Brief Illness perception questionnaire

Time frame: Baseline, 6,12 and 18 months after randomization

Data from ClinicalTrials.gov

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