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NCT Number: NCT03847766

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birgith Engelst Grove

Herning, 7400, Denmark

About this study

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

  • PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not)
  • PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRO-based follow-up

Behavioral

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

Other names: TelePRO

PRO-based telephone consultation

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality

    Time frame: 18 months after randomization

    Overall mortality

  2. End Stage Renal Disease (ESRD)

    Time frame: 18 months after randomization

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

  3. Kidney transplantation

    Time frame: 18 months after randomization

    Has the patient received a kidney transplant during follow-up

  4. Hospital admission

    Time frame: From baseline at 18 months after randomization

    Difference in number of admissions

  5. 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

  6. 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

  7. Illness perception (BIPQ)

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

    Illness perception will be assessed by the Brief Illness perception questionnaire

  8. 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

  9. 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

  10. Confidence

    Time frame: 6,12,18 months after randomization

    Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire

  11. 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

  12. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PROKID

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2019
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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