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Trial record 1 of 2 for:    PROKID
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Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease (PROKID)

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ClinicalTrials.gov Identifier: NCT03847766
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborators:
Regional Hospital West Jutland
Aarhus University Hospital
TrygFonden, Denmark
Karen Elise Jensen Foundation
Sygekassernes Helsefond
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Behavioral: PRO-based follow-up Behavioral: PRO-based telephone consultation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process.

Patients in the intervention arms will receive diagnosis specific questionnaires through a safe internet connection every third month. The responses are seen by the clinicians in the Electronic Health Record.

Patients will receive 2 reminders if they do not answer the questionnaires and clinicians will call the patient

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847766


Contacts
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Contact: Birgith Grove, MHSc +45 28904835 bigcri@rm.dk
Contact: Per Ivarsen, MD perivars@rm.dk

Locations
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Denmark
Birgith Engelst Grove Recruiting
Herning, Denmark, 7400
Contact: Birgith Grove, MHSc    0045 28904835    bigcri@rm.dk   
Principal Investigator: Per Ivarsen, MD         
Sub-Investigator: Annette De Thurah, PhD         
Sponsors and Collaborators
University of Aarhus
Regional Hospital West Jutland
Aarhus University Hospital
TrygFonden, Denmark
Karen Elise Jensen Foundation
Sygekassernes Helsefond
Investigators
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Study Director: Niels Henrik Hjollund, MD,Professor Regional Hospital West Jutland
Principal Investigator: Birgith Grove, MHSc Aarhus University Hospital & Regional Hospital West Jutland
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 31484523
Data can be accessed by request from the corresponding author

Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03847766    
Other Study ID Numbers: PROKID
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
PRO-based follow-up, TelePRO
Outpatients, Chronic Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency