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

Chronic Kidney Diseases Clinical Trial

— PROKID  

Official title:

Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847766
• Other study ID #: PROKID
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• PRO-based follow-up
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
• PRO-based telephone consultation
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation

Locations

Country	Name	City	State
Denmark	Birgith Engelst Grove	Herning

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Karen Elise Jensen Foundation, Regional Hospital West Jutland, Sygekassernes Helsefond, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline questionnaires of non-participants	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.	Baseline questionnaires
Primary	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	Mortality	Overall mortality	18 months after randomization
Secondary	End Stage Renal Disease (ESRD)	Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis	18 months after randomization
Secondary	Kidney transplantation	Has the patient received a kidney transplant during follow-up	18 months after randomization
Secondary	Hospital admission	Difference in number of admissions	From baseline at 18 months after randomization
Secondary	Number of contacts	Number of contacts includes all contacts with the outpatient clinic in the study follow-up period	18 months after randomization
Secondary	General Health (SF36),	General health will be assessed by items from the SF-36 questionnaire	Baseline, 6,12 and 18 months after randomization
Secondary	Illness perception (BIPQ)	Illness perception will be assessed by the Brief Illness perception questionnaire	Baseline, 6,12 and 18 months after randomization
Secondary	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	Baseline, 6,12 and 18 months after randomization
Secondary	Satisfaction with care	Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire	6,12,18 months after randomization
Secondary	Confidence	Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire	6,12,18 months after randomization
Secondary	Treatment safety	Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire	6,12,18 months after randomization
Secondary	Patient involvement	Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire	Patient involvement will be measured at 6,12 and18 months