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

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Behavioral: PRO-based follow-up; Behavioral: PRO-based telephone consultation

• Registration Number: NCT03847766
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Status Verified: 2023-12
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRO-based follow-up	PRO-based follow-up	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.
PRO-based telephone consultations	PRO-based telephone consultation	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months	Measured at baseline, 6, 12 and 18 months after randomisation	Measurement for renal function

Secondary Outcome Measures

Name	Time	Method
End Stage Renal Disease (ESRD)	18 months after randomization	Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis
General Health (SF36),	Baseline, 6,12 and 18 months after randomization	General health will be assessed by items from the SF-36 questionnaire
Patient involvement	Patient involvement will be measured at 6,12 and18 months	Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire
Mortality	18 months after randomization	Overall mortality
Kidney transplantation	18 months after randomization	Has the patient received a kidney transplant during follow-up
Hospital admission	From baseline at 18 months after randomization	Difference in number of admissions
Quality of Life (EQ-5D)	Baseline, 6,12 and 18 months after randomization	EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention
Illness perception (BIPQ)	Baseline, 6,12 and 18 months after randomization	Illness perception will be assessed by the Brief Illness perception questionnaire
Number of contacts	18 months after randomization	Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
Treatment safety	6,12,18 months after randomization	Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Satisfaction with care	6,12,18 months after randomization	Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire
Confidence	6,12,18 months after randomization	Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire

Trial Locations

Locations (1)

Birgith Engelst Grove; 🇩🇰 Herning, Denmark