Clinical trial NCT03847766: Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease
Official title: Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: PRO-based follow-up, TelePRO
Outpatients, Chronic Kidney Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regional Hospital West Jutland
name: Aarhus University Hospital
name: TrygFonden, Denmark
name: Karen Elise Jensen Foundation
name: Sygekassernes Helsefond
First posted: 2019-02-20
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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

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.

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

Primary outcomes:
measure: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
timeFrame: Measured at baseline, 6, 12 and 18 months after randomisation
Secondary outcomes:
measure: Mortality
timeFrame: 18 months after randomization
measure: End Stage Renal Disease (ESRD)
timeFrame: 18 months after randomization
measure: Kidney transplantation
timeFrame: 18 months after randomization
measure: Hospital admission
timeFrame: From baseline at 18 months after randomization
measure: Number of contacts
timeFrame: 18 months after randomization
measure: General Health (SF36),
timeFrame: Baseline, 6,12 and 18 months after randomization
measure: Illness perception (BIPQ)
timeFrame: Baseline, 6,12 and 18 months after randomization
measure: Quality of Life (EQ-5D)
timeFrame: Baseline, 6,12 and 18 months after randomization
measure: Satisfaction with care
timeFrame: 6,12,18 months after randomization
measure: Confidence
timeFrame: 6,12,18 months after randomization
measure: Treatment safety
timeFrame: 6,12,18 months after randomization
measure: Patient involvement
timeFrame: Patient involvement will be measured at 6,12 and18 months
Other outcomes:
measure: Baseline questionnaires of non-participants
timeFrame: Baseline questionnaires
Locations:
city: Herning
country: Denmark
facility: Birgith Engelst Grove
Study officials:
affiliation: Regional Hospital West Jutland
name: Niels Henrik Hjollund, MD,Professor
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital & Regional Hospital West Jutland
name: Birgith Grove, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
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.