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AzTrials

Chronic Kidney DiseasesPROKIDNCT03847766

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

A study testing PRO-based follow-up and PRO-based telephone consultation in people with Chronic Kidney Diseases, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
PRO-based follow-up and PRO-based telephone consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteDenmark
Study dates
3 Dec 2018to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Birgith Engelst Grove

    Herning, 7400

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
PRO-based follow-up, PRO-based telephone consultation
Keywords
PRO-based follow-up, TelePRO, Outpatients, Chronic Kidney Disease
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO-based follow-upBehavioural

    Also called TelePRO

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

  • PRO-based telephone consultationBehavioural

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

Study groups in NCT03847766
Study groupRoleWhat they receive
PRO-based follow-upExperimentalPatients 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.
Receives: Behavioral: PRO-based follow-up
PRO-based telephone consultationsExperimentalPatients 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.
Receives: Behavioral: PRO-based telephone consultation
Usual outpatient follow-up visitsNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months

    Measurement for renal function

    Measured: Measured at baseline, 6, 12 and 18 months after randomisation

Secondary outcomes (12)

  1. Mortality

    Overall mortality

    Measured: 18 months after randomization

  2. End Stage Renal Disease (ESRD)

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

    Measured: 18 months after randomization

  3. Kidney transplantation

    Has the patient received a kidney transplant during follow-up

    Measured: 18 months after randomization

  4. Hospital admission

    Difference in number of admissions

    Measured: From baseline at 18 months after randomization

  5. Number of contacts

    Number of contacts includes all contacts with the outpatient clinic in the study follow-up period

    Measured: 18 months after randomization

  6. General Health (SF36),

    General health will be assessed by items from the SF-36 questionnaire

    Measured: Baseline, 6,12 and 18 months after randomization

  7. Illness perception (BIPQ)

    Illness perception will be assessed by the Brief Illness perception questionnaire

    Measured: Baseline, 6,12 and 18 months after randomization

  8. 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

    Measured: Baseline, 6,12 and 18 months after randomization

  9. Satisfaction with care

    Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire

    Measured: 6,12,18 months after randomization

  10. Confidence

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

    Measured: 6,12,18 months after randomization

  11. Treatment safety

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

    Measured: 6,12,18 months after randomization

  12. Patient involvement

    Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire

    Measured: Patient involvement will be measured at 6,12 and18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start3 Dec 2018
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03847766
Sponsor's protocol ID
PROKID
Acronym
PROKID
Status last verified
Dec 2023
First submitted
23 Jan 2019
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31484523

  • Grove BE, Schougaard LMV, Mose F, Randers E, Hjollund NH, Ivarsen P, De Thurah A. Remote symptom monitoring with patient-reported outcome measures in outpatients with chronic kidney disease (PROKID): a multicentre randomised controlled non-inferiority study. Clin Kidney J. 2024 Jun 14;17(7):sfae176. doi: 10.1093/ckj/sfae176. eCollection 2024 Jul.

    PubMed 39006159

  • Grove BE, de Thurah A, Ivarsen P, Kvisgaard AK, Hjollund NH, Grytnes R, Schougaard LMV. Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2024 Apr 24;8:e48173. doi: 10.2196/48173.

    PubMed 38656781

Questions about this trial

What is this clinical trial studying?

A study testing PRO-based follow-up and PRO-based telephone consultation in people with Chronic Kidney Diseases, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (time frame: Measured at baseline, 6, 12 and 18 months after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03847766, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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