Chronic Kidney Diseases
Conditions
Keywords
PRO-based follow-up, TelePRO, Outpatients, Chronic Kidney Disease
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.
Interventions
BEHAVIORALPRO-based follow-up
Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
BEHAVIORALPRO-based telephone consultation
diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
Sponsors
Regional Hospital West Jutland
Aarhus University Hospital
TrygFonden, Denmark
Karen Elise Jensen Foundation
Sygekassernes Helsefond
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months | Measured at baseline, 6, 12 and 18 months after randomisation | Measurement for renal function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of contacts | 18 months after randomization | Number of contacts includes all contacts with the outpatient clinic in the study follow-up period |
| Mortality | 18 months after randomization | Overall mortality |
| End Stage Renal Disease (ESRD) | 18 months after randomization | Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis |
| Kidney transplantation | 18 months after randomization | Has the patient received a kidney transplant during follow-up |
| Hospital admission | From baseline at 18 months after randomization | Difference in number of admissions |
| General Health (SF36), | Baseline, 6,12 and 18 months after randomization | General health will be assessed by items from the SF-36 questionnaire |
| Quality of Life (EQ-5D) | Baseline, 6,12 and 18 months after randomization | 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 | 6,12,18 months after randomization | Satisfaction will be assessed by one item from the Danish Cancer Society Patient reported experience measures PREM (Barometer) Questionnaire |
| Confidence | 6,12,18 months after randomization | Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire |
| Treatment safety | 6,12,18 months after randomization | Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire |
| Patient involvement | Patient involvement will be measured at 6,12 and18 months | Patient involvement will be assessed by 5 questions from DEFACTUM (Central Denmark Region) Questionnaire |
| Illness perception (BIPQ) | Baseline, 6,12 and 18 months after randomization | Illness perception will be assessed by the Brief Illness perception questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline questionnaires of non-participants | Baseline questionnaires | 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. |
Countries
Denmark
Outcome results
None listed