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

University of Aarhus

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Behavioral: PRO-based telephone consultation; Behavioral: PRO-based follow-up

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03847766

PROKID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

PRO-based follow-up

Experimental group

Description:

Patients will receive a questionnaire every 3 months. The PRO questionnaire is used as decision aid together with other available clinical data to decide whether the patient needs a visit or not. Hence, patients only visit the outpatient clinic if there is a clinical need or a patient's wish. The actual response for each questionnaire automatically results in a colour code (green, yellow or red). A red or yellow response indicates that the patient needs to be contacted. A green colour indicates no need for a visit. Based on an overview of the questionnaire and the patient's blood samples a physician decides whether this patient should have a telephone consultation or the patient needs to be seen in the clinic.

Treatment:

Behavioral: PRO-based follow-up

PRO-based telephone consultations

Experimental group

Description:

Patients receive an electronic questionnaire every 3 months prior to a scheduled telephone consultation.The PRO questionnaire is used as dialogue support during the telephone consultation. The actual response for each item automatically results in a colour code (green, yellow or red). A red response indicates that the patient has a problem; a yellow colour indicates a potential problem, while a green colour indicates no problems.

Treatment:

Behavioral: PRO-based telephone consultation

Usual outpatient follow-up visits

No Intervention group

Description:

Patients in the control group will continue to have usual scheduled outpatient follow-up visits at the hospital initiated by the physician every 3 months. These patients do not use the clinical PRO questionnaire, but complete the research questionnaires.