NCT07613593招募中不适用
INCLUDE-CKD: INCLUsive Digital carE for Chronic Kidney Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
This study will provide valuable insights into the demographics of MyRenalCare users, their digital adherence, and the overall impact of the app on health outcomes, healthcare costs, and environmental sustainability.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •5.1.1 Inclusion criteria - MyRenalCare users (retrospective and prospective cohorts)
- •Adults will be eligible for inclusion in the MyRenalCare cohorts if they meet all of the following:
- •Aged 18 years or over.
- •Under the care of the Wessex Kidney Centre
- •Registered with, or offered and subsequently enrolled onto, the MyRenalCare platform during the defined retrospective or prospective periods.
- •Able to understand study information and, where applicable, provide informed consent for use of their data for research purposes.
- •Specific CKD stage definitions and thresholds (e.g. based on eGFR, albuminuria or uPCR) will be documented in the study manual to ensure consistent application.
- •5.1.2 Inclusion criteria - matched usual care controls
- •Adults will be eligible for inclusion in the matched control cohorts if they meet all of the following:
- •Aged 18 years or over.
- •Under the care of the Wessex Kidney Centre for chronic kidney disease.
- •Not registered with or using MyRenalCare at any point during the relevant observation period.
- •Have sufficient clinical and administrative data available in the renal electronic patient record to enable matching and outcome assessment.
- •Controls will be identified retrospectively from the renal electronic patient record and matched to MyRenalCare users using a predefined matching strategy.
- •5.1.3 Inclusion criteria - qualitative interview participants (patients and staff)
- •Patients will be eligible to take part in the qualitative interview component if they meet all of the following:
- •Aged 18 years or over.
- •Currently using, or recently offered, the MyRenalCare platform as part of their CKD care at the Wessex Kidney Centre.
- •Able to understand spoken and written English to the extent required for participation in an interview.
- •Able and willing to provide written informed consent for participation in a recorded interview.
- •Belong to a demographic or clinical subgroup of interest for the study (e.g. varying age, ethnicity, CKD stage, or digital engagement level), as part of purposive sampling to support diversity and equity analysis.
- •Clinical staff will be eligible if they meet all of the following:
- •Employed by PHU or working in direct partnership with the Wessex Kidney Centre.
- •Directly involved in the care of patients with chronic kidney disease and/or in the implementation or support of MyRenalCare.
- •Able and willing to provide informed consent for a recorded interview.
- •Able to reflect on experiences and observations relevant to the delivery, uptake, or equity implications of digital health in CKD.
排除标准
- •Patients with acute kidney injury without established chronic kidney disease.
- •Patients with a very limited life expectancy where participation in routine digital monitoring is not appropriate, as judged by the clinical team.
- •Patients who have previously indicated that they do not wish their routinely collected clinical data to be used for research where such opt-out applies to this study.
- •Patients who are unable to be identified reliably in the available data sources (for example, inconsistent or missing key identifiers).
- •Any other situation where, in the opinion of the responsible clinician, participation in the study processes (including data use) would be inappropriate or unduly burdensome.
- •Clinical staff who are not directly involved in the care of patients with chronic kidney disease or in the implementation of the MyRenalCare platform.
- •Staff members currently on extended leave or unable to participate during the data collection period.
- •Individuals who do not wish to have their views included in recorded interview transcripts or are unable to provide informed consent for participation.
- •Any situation where, in the opinion of the study team or the individual's manager, participation would be inappropriate or burdensome due to role, availability, or conflict of interest.
研究组 & 干预措施
Patients and staff participating in qualitative interviews (qualitative cohort)
A subset of MyRenalCare users (both retrospective and prospective) and clinical staff involved in their care who are invited to take part in interviews about their experiences with MyRenalCare.
干预措施: Non-Interventional Study (Other)
Existing MyRenalCare users (retrospective cohort)
Adults who were already registered and actively using MyRenalCare at the start of the retrospective observation period. Data will be collected retrospectively from their routine use of the platform.
干预措施: Non-Interventional Study (Other)
New MyRenalCare users (prospective cohort)
Adults who are newly offered and enroll onto MyRenalCare during the defined recruitment window. Participants will use the platform as part of routine care, and their engagement will be prospectively monitored.
干预措施: Non-Interventional Study (Other)
Matched usual care controls
Adults with CKD receiving standard care at the Wessex Kidney Centre who are not enrolled onto MyRenalCare. These participants receive usual clinical care without access to the MyRenalCare platform.
干预措施: Non-Interventional Study (Other)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Using Telemedicine to Improve Self-Care Among People with Chronic Kidney DiseaseCTRI/2025/10/096038BP Koirala Institute of Health Science108
招募中
不适用
Studying the Management of Anaemia in Indian Patients with Chronic Kidney Disease, with and without DialysisCTRI/2025/01/079069Dr Reddys Laboratories Road No Banjara Hills Hyderabad Telangana India1,000
Enrolling By Invitation
不适用
The Mindful Kidney: Supporting Mindfulness for Adults With Chronic Kidney DiseaseChronic Kidney DiseaseNCT07541495Yale University26
招募中
4 期
Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South Asian Kidney Biopsy proven Adult Primary IgA NephropathyCTRI/2024/11/076794Suceena Alexander585
尚未招募
不适用
Exploring the outcome of Combined Ayurvedic Treatments on Chronic Kidney Disease patients: An Observational studyCTRI/2024/10/074564All India Institute Of Ayurveda30