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

December 21, 2023 updated by: University of Aarhus

Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Birgith Engelst Grove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: PRO-based follow-up
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
Other Names:
  • TelePRO
Experimental: PRO-based telephone consultations
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.
Behavioral: PRO-based telephone consultation
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
No Intervention: Usual outpatient follow-up visits
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
Time Frame: Measured at baseline, 6, 12 and 18 months after randomisation
Measurement for renal function
Measured at baseline, 6, 12 and 18 months after randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 18 months after randomization
Overall mortality
18 months after randomization
End Stage Renal Disease (ESRD)
Time Frame: 18 months after randomization
Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis
18 months after randomization
Kidney transplantation
Time Frame: 18 months after randomization
Has the patient received a kidney transplant during follow-up
18 months after randomization
Hospital admission
Time Frame: From baseline at 18 months after randomization
Difference in number of admissions
From baseline at 18 months after randomization
Number of contacts
Time Frame: 18 months after randomization
Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
18 months after randomization
General Health (SF36),
Time Frame: Baseline, 6,12 and 18 months after randomization
General health will be assessed by items from the SF-36 questionnaire
Baseline, 6,12 and 18 months after randomization
Illness perception (BIPQ)
Time Frame: Baseline, 6,12 and 18 months after randomization
Illness perception will be assessed by the Brief Illness perception questionnaire
Baseline, 6,12 and 18 months after randomization
Quality of Life (EQ-5D)
Time Frame: 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
Baseline, 6,12 and 18 months after randomization
Satisfaction with care
Time Frame: 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
6,12,18 months after randomization
Confidence
Time Frame: 6,12,18 months after randomization
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
6,12,18 months after randomization
Treatment safety
Time Frame: 6,12,18 months after randomization
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
6,12,18 months after randomization
Patient involvement
Time Frame: Patient involvement will be measured at 6,12 and18 months
Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire
Patient involvement will be measured at 6,12 and18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline questionnaires of non-participants
Time Frame: Baseline questionnaires
All patients who met the inclusion criteria will be asked to fill in a questionnaire. The questionnaire will include Health Literacy (subscale 4,6,9), Selfefficacy, General Health (SF-36) and 5 renal specific symptoms (KDQOL), Patient activation (2+12), education and employment status. The purpose is to identify baseline differences between participants and non-participants and thereby testing the PRO system for generalizability.
Baseline questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
TrygFonden, Denmark
Sygekassernes Helsefond
Regional Hospital West Jutland
Karen Elise Jensen Foundation

Investigators

  • Study Director: Niels Henrik Hjollund, MD,Professor, Regional Hospital West Jutland
  • Principal Investigator: Birgith Grove, MHSc, Aarhus University Hospital & Regional Hospital West Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROKID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: 31484523
    Information comments: Data can be accessed by request from the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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