Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regional Hospital West Jutland | OTHER |
| Aarhus University Hospital | OTHER |
| TrygFonden, Denmark | INDUSTRY |
| Karen Elise Jensen Foundation |
Not provided
Not provided
Not provided
Not provided
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.
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-based follow-up | Behavioral | Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Overall mortality | 18 months after randomization |
| End Stage Renal Disease (ESRD) | Has the patient initiated dialyses during follow-up, Hemodialysis, peritoneal dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niels Henrik Hjollund, MD,Professor | Regional Hospital West Jutland | Study Director |
| Birgith Grove, MHSc | Aarhus University Hospital & Regional Hospital West Jutland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birgith Engelst Grove | Herning | 7400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31484523 | Background | 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. | |
| 39006159 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| 31484523 | Study Protocol | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| OTHER |
| Sygekassernes Helsefond | OTHER |
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
Not provided
Not provided
Not provided
Not provided
| PRO-based telephone consultation | Behavioral | diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation |
|
| 18 months after randomization |
| Kidney transplantation | Has the patient received a kidney transplant during follow-up | 18 months after randomization |
| Hospital admission | Difference in number of admissions | From baseline at 18 months after randomization |
| Number of contacts | Number of contacts includes all contacts with the outpatient clinic in the study follow-up period | 18 months after randomization |
| General Health (SF36), | General health will be assessed by items from the SF-36 questionnaire | Baseline, 6,12 and 18 months after randomization |
| Illness perception (BIPQ) | Illness perception will be assessed by the Brief Illness perception questionnaire | Baseline, 6,12 and 18 months after randomization |
| 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 |
| 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 |
| Confidence | Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | 6,12,18 months after randomization |
| Treatment safety | Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | 6,12,18 months after randomization |
| 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 |
| Baseline questionnaires |
| 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. |
| 38656781 | 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. |
Data can be accessed by request from the corresponding author |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |