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Идёт набор NCT04212923

EHealth Based Self-management Intervention for Chronic Kidney Disease Care in China

Без фазы С лечением Chronic Kidney Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Medical Dashboard based self-management intervention.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to develop an evidence-based tailored eHealth self-management intervention for patients with chronic kidney disease in China, and test the impact on implementation and effectiveness of interventions.

Подробное описание

Interventions that support disease self-management (further referred to as 'self-management interventions') can have a significant impact on the health and quality of life of patients suffering from chronic conditions in general and chronic kidney disease (CKD) patients in specific. In the last decade, the use of electronic health (eHealth) technology in self-management interventions has become more and more popular. EHealth-based self-management interventions have been shown to improve health-related outcomes, such as blood pressure (BP) control and medication adherence, and found to be feasible and acceptable for CKD patients and care professionals. Hence, the use of eHealth self-management interventions for CKD patients has become increasingly popular. Knowledge of the implementation and effectivity of such interventions in China and other developing countries is, however, still lacking. Researchers from the Leiden University Medical Center (LUMC) developed 'Medical Dashboard', an eHealth intervention to help support and involve CKD patients in their disease self-management. We aim to tailor the evidence-based Dutch intervention 'Medical Dashboard' to the Chinese context and evaluate its implementation process and effectiveness.

Вмешательства

  • Поведенческое Medical Dashboard based self-management intervention
    Before the start of the intervention, chronic kidney disease patients and care providers will receive a face-to-face training session on the use of Medical Dashboard. To avoid contamination, Medical Dashboard will only be made accessible for participants in the intervention group via a secure password-protected registration process.

Первичные конечные точки

  • Change of chronic kidney disease self-management behavior using Chronic Kidney Disease Self-Management (CKD-SM) instrument from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
Вторичные конечные точки (12)
  • Change of blood pressure from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of body weight from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomization, 6 months after randomization, 9 months after randomization (endpoint)]
  • Change of glomerular filtration rate from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of serum albumin from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of serum creatinine from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of number of complications patients have from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of chronic kidney disease self-efficacy using Chronic Kidney Disease Self-efficacy (CKD-SE) scale from baseline to 3, 6 and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 6 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of chronic kidney disease illness perception using Brief Illness Perception Questionnaire (BIPQ) from baseline to 9 months after randomization [Срок оценки: 0 month (baseline), 9 months after randomisation (endpoint)]
  • Change of chronic kidney disease anxiety and depression status using the Hospital Anxiety and Depression Scale (HADS) from baseline to 3, and 9 months after randomization [Срок оценки: 0 month (baseline), 3 months after randomisation, 9 months after randomisation (endpoint)]
  • Change of chronic kidney disease quality of life using the Kidney Disease Quality of Life 36-item short-form survey (KDQOL-36) from baseline to 9 months after randomization [Срок оценки: 0 month (baseline), 9 months after randomisation (endpoint)]
  • Hospital admission [Срок оценки: 9 months after randomisation (endpoint)]
  • Change of healthcare utilisation from 3 months after randomisation to 9 months after randomisation [Срок оценки: 3 months after randomisation, 9 months after randomisation (endpoint)]

Критерии участия

Критерии включения

  • Patients: (1) aged over 18 years old; (2) diagnosis of chronic kidney disease; (3) Chinese speaking.
  • Health care providers who work in the Department of Nephrology

Критерии исключения

  • Individuals unable to participate due to physical or mental disabilities.
  • Individuals unable to write or read.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Публикации

  • Shen H, van der Kleij R, van der Boog PJM, Chavannes NH. Developing a Tailored eHealth Self-Management Intervention for Patients With Chronic Kidney Disease in China: Intervention Mapping Approach. JMIR Form Res. 2024 Jun 13;8:e48605. doi: 10.2196/48605. PMID 38869943
  • Shen H, van der Kleij R, van der Boog PJM, Song X, Wang W, Zhang T, Li Z, Lou X, Chavannes N. Development and evaluation of an eHealth self-management intervention for patients with chronic kidney disease in China: protocol for a mixed-method hybrid type 2 trial. BMC Nephrol. 2020 Nov 19;21(1):495. doi: 10.1186/s12882-020-02160-6. PMID 33213398

Идентификаторы

NCT: NCT04212923 · 201707040096

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗