Background
Chronic kidney disease
Patient reported outcome (PRO) measures
Methods
Aim
Hypothesis
Three a priori hypotheses will be tested
Design
Study population
Inclusion criteria
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EGFR between 10 and 39 mL/min 1.73m2
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Aged ≥18 years old
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Ability to answer a questionnaire and participate in the study
Exclusion criteria
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Patients unwilling to participate in PRO-based follow-up
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Patients who, in the opinion of the consenting professional, cannot speak, read or write Danish sufficiently well to complete the PRO questionnaire unaided
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Patients with impaired hearing or visual disabilities
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A projected risk of progression to end-stage renal disease within 12 months, determined from albumin/creatinine ratio > 1
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Patients with an eGFR ≤10 mL/min 1.73 m2 due to a projected risk of progression to end-stage renal disease
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Patients who have received (or have a scheduled date to receive) a kidney transplant
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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
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Patients receiving chemotherapy, with end stage chronic obstructive lung disease, or with heart failure with an ejection fraction (EF) < 15%
Randomisation
Study timeline
Name | Introduction | Baseline | Clinical questionnaire | Research questionnaire |
---|---|---|---|---|
Purpose | Identify determinants for patients choosing PRO-based follow-up | Baseline characteristics | Using questionnaire as screenings tool and dialogue support | Repeated measures of characteristics |
Respondents | ALL newly referred patients in renal outpatient clinic | ALL enrolled patients in PROKID study | Participants in PRO-based follow-up and in PRO-based telephone consultation arm | ALL patients in the three randomisation groups |
Content | • Renal-specific items • SF-GH1 • HLQa (subscale 4,6,9) • Self-efficacyb • PAMc(2 + 12) • Demographic • Consent (Yes/no)h | • Renal-specific domains • SF-GH1d • EQ-5De • BIPQf | Renal-specific domains • KDQOL-SFg • EORTC • SF-GH1 • Need/wish for consultation • Free textbox | • Self-efficacy • EQ-5D • BIPQ • Patient involvement • Confidence • Satisfaction |
No items | 36 | 37 | 29 | 27 |
PRO clinical questionnaire
PRO research questionnaire
Interventions
Intervention group – PRO-based remote follow-up
Intervention group – PRO-based telephone consultations
Usual care (control group)
Outcomes
Outcomes
|
Data source
|
Measurement/month
|
---|---|---|
Clinical outcomes
| ||
Renal function (eGFR) | Electronic health record (EHR) | 0,3,6,9,12,15,18 |
Mortality | Electronic health record (EHR) | 6,12,18 |
Initiation of dialysis | Electronic health record (EHR) | 6,12,18 |
Transplantation | Electronic health record (EHR) | 6, 12,18 |
Hospitalisation | Electronic health record (EHR) | 16,12,18 |
CKD biomarkers | Electronic health record (EHR) | 0,3,6,9,12,15,18 |
Resource utilisation
| ||
Number of face-to-face visits | Electronic health record (EHR) | 6,12,18 |
Unexpected contacts | Electronic health record (EHR) | 6,12,18 |
Phone contacts | Electronic health record (EHR) | 6,12,18 |
Patient-reported outcomes
| ||
Quality of life | Euroqol (EQ-5D 5 L) | 0,6,12,18 |
General health | Short Form-36 (SF-36) | 0,6,12,18 |
Illness perception | Brief Illness Perception (IPQ-B) | 0,6,12,18 |
Self-efficacy | General Self-efficacy (GSE) | 0,12,18 |
Patient involvement | AmbuFlex PRO questionnaire | 6,12,18 |
Confidence, satisfaction | AmbuFlex PRO questionnaire | 6,12,18 |
Primary outcome
The secondary outcomes
Clinical outcomes
Resource Utilisation
Patient-reported outcomes
Demographic, clinical and laboratory variables
Other measurements
Statistical methods
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Continuous endpoints (e.g. quality of life, estimated Glomerular Filtration Rate): These data will be summarised using means and standard deviations, with differences in means and 95% confidence intervals reported. Longitudinal plots of the data over time will also be constructed for visual presentation of the data. The primary analysis will be adjusted for covariates identified as potentially prognostic variables (e.g. sex and age) in a multiple linear regression model. A secondary unadjusted analysis will also be performed if covariate adjustment is not practical (e.g. due to low event rates).
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Categorical (dichotomous) endpoints (e.g. PRO data, hospitalisation rates): For dichotomous secondary endpoints, the proportion of participants and percentages will be summarised between arms. Logistic regression will be used to produce estimates of relative risks and 95% confidence intervals.
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Time-to-event endpoints (e.g. time to initiation of dialysis, mortality): These endpoints will be modelled for each randomisation arm using survival analysis methods. Kaplan–Meier survival curves will be constructed for visual presentation of time-to-event comparisons. The primary analysis will be carried out using a Cox proportional hazards or an extended Cox model to include prognostic covariates. Hazard ratios will be produced with 95% confidence intervals.