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

NCT03847766 | Completed DMC

• 1 other identifier: PROKID
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

PRO-based follow-up, TelePRO; Outpatients, Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

  Measurement for renal function

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

Secondary Outcomes (12)

• Mortality

  18 months after randomization

• End Stage Renal Disease (ESRD)

  18 months after randomization

• Kidney transplantation

  18 months after randomization

• Hospital admission

  From baseline at 18 months after randomization

• Number of contacts

  18 months after randomization

Other Outcomes (1)

• Baseline questionnaires of non-participants

  Baseline questionnaires

Study Arms (3)

PRO-based follow-up

EXPERIMENTAL

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

PRO-based telephone consultations

EXPERIMENTAL

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

Usual outpatient follow-up visits

NO INTERVENTION

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.

Interventions

PRO-based follow-up BEHAVIORAL

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

Also known as: TelePRO

PRO-based follow-up

PRO-based telephone consultation BEHAVIORAL

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

PRO-based telephone consultations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Birgith Engelst Grove

Herning, 7400, Denmark

Location

Related Publications (3)

• 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.

  PMID: 31484523 BACKGROUND

• 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.

  PMID: 39006159 DERIVED

• 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.

  PMID: 38656781 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Niels Henrik Hjollund, MD,Professor

  Regional Hospital West Jutland

  STUDY DIRECTOR

• Birgith Grove, MHSc

  Aarhus University Hospital & Regional Hospital West Jutland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 20, 2019
• Study Start: December 3, 2018
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)