Tele Follow-up Using Patient-reported Outcomes (PRO) Measures in Patients With Chronic Kidney Disease - the PROKID Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
研究概览
简要总结
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.
详细描述
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
- PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not)
- PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 1.73m
- •Aged ≥18 years old
- •Ability to provide fully informed written consent for participation in the study
排除标准
- •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
研究组 & 干预措施
PRO-based follow-up
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.
干预措施: PRO-based follow-up (Behavioral)
PRO-based telephone consultations
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.
干预措施: PRO-based telephone consultation (Behavioral)
Usual outpatient follow-up visits
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.
结局指标
主要结局
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months
时间窗: Measured at baseline, 6, 12 and 18 months after randomisation
Measurement for renal function
次要结局
- Treatment safety(6,12,18 months after randomization)
- End Stage Renal Disease (ESRD)(18 months after randomization)
- General Health (SF36),(Baseline, 6,12 and 18 months after randomization)
- Patient involvement(Patient involvement will be measured at 6,12 and18 months)
- Mortality(18 months after randomization)
- Kidney transplantation(18 months after randomization)
- Hospital admission(From baseline at 18 months after randomization)
- Quality of Life (EQ-5D)(Baseline, 6,12 and 18 months after randomization)
- Illness perception (BIPQ)(Baseline, 6,12 and 18 months after randomization)
- Number of contacts(18 months after randomization)
- Satisfaction with care(6,12,18 months after randomization)
- Confidence(6,12,18 months after randomization)