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

Primary Purpose

Chronic Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PRO-based follow-up
PRO-based telephone consultation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring PRO-based follow-up, TelePRO, Outpatients, Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Birgith Engelst Grove

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

PRO-based follow-up

PRO-based telephone consultations

Usual outpatient follow-up visits

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
Measurement for renal function

Secondary Outcome Measures

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

Full Information

First Posted
January 23, 2019
Last Updated
May 17, 2022
Sponsor
University of Aarhus
Collaborators
Regional Hospital West Jutland, Aarhus University Hospital, TrygFonden, Denmark, Karen Elise Jensen Foundation, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT03847766
Brief Title
Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease
Acronym
PROKID
Official Title
Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Regional Hospital West Jutland, Aarhus University Hospital, TrygFonden, Denmark, Karen Elise Jensen Foundation, Sygekassernes Helsefond

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
PRO-based follow-up, TelePRO, Outpatients, Chronic Kidney Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRO-based follow-up
Arm Type
Experimental
Arm 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.
Arm Title
PRO-based telephone consultations
Arm Type
Experimental
Arm 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.
Arm Title
Usual outpatient follow-up visits
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PRO-based follow-up
Other Intervention Name(s)
TelePRO
Intervention Description
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
Intervention Type
Behavioral
Intervention Name(s)
PRO-based telephone consultation
Intervention Description
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
Primary Outcome Measure Information:
Title
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
Description
Measurement for renal function
Time Frame
Measured at baseline, 6, 12 and 18 months after randomisation
Secondary Outcome Measure Information:
Title
Mortality
Description
Overall mortality
Time Frame
18 months after randomization
Title
End Stage Renal Disease (ESRD)
Description
Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis
Time Frame
18 months after randomization
Title
Kidney transplantation
Description
Has the patient received a kidney transplant during follow-up
Time Frame
18 months after randomization
Title
Hospital admission
Description
Difference in number of admissions
Time Frame
From baseline at 18 months after randomization
Title
Number of contacts
Description
Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
Time Frame
18 months after randomization
Title
General Health (SF36),
Description
General health will be assessed by items from the SF-36 questionnaire
Time Frame
Baseline, 6,12 and 18 months after randomization
Title
Illness perception (BIPQ)
Description
Illness perception will be assessed by the Brief Illness perception questionnaire
Time Frame
Baseline, 6,12 and 18 months after randomization
Title
Quality of Life (EQ-5D)
Description
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
Time Frame
Baseline, 6,12 and 18 months after randomization
Title
Satisfaction with care
Description
Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire
Time Frame
6,12,18 months after randomization
Title
Confidence
Description
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time Frame
6,12,18 months after randomization
Title
Treatment safety
Description
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time Frame
6,12,18 months after randomization
Title
Patient involvement
Description
Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire
Time Frame
Patient involvement will be measured at 6,12 and18 months
Other Pre-specified Outcome Measures:
Title
Baseline questionnaires of non-participants
Description
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.
Time Frame
Baseline questionnaires

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Henrik Hjollund, MD,Professor
Organizational Affiliation
Regional Hospital West Jutland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Birgith Grove, MHSc
Organizational Affiliation
Aarhus University Hospital & Regional Hospital West Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birgith Engelst Grove
City
Herning
ZIP/Postal Code
7400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31484523
Citation
Grove BE, Ivarsen P, de Thurah A, Schougaard LM, Kyte D, Hjollund NH. Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial. BMC Health Serv Res. 2019 Sep 4;19(1):631. doi: 10.1186/s12913-019-4461-y.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/31484523/
Available IPD/Information Identifier
31484523
Available IPD/Information Comments
Data can be accessed by request from the corresponding author

Learn more about this trial

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

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