- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291154
Impact of APP-assisted Patient Management on the Quality Control of Blood Purification Therapy
Many maintenance hemodialysis (MHD) patients develop negative outlooks due to their illnesses and complications, making their quality of life and prognosis a clinical concern. Effective life management and treatment cooperation are crucial to improving dialysis quality and patient outcomes. This trial aims to evaluate whether management through the "Yueya" mini-program and WeChat can provide personalized guidance such as health education, diet, exercise, medication supervision, and condition monitoring to enhance treatment compliance, quality of life, strengthen quality control in the hemodialysis unit, and improve patient prognosis.
Patients will be divided into a group receiving support via the "Yueya" mini-program and WeChat, and a control group receiving routine care. Clinical and laboratory indicators, cardiovascular events, death, hospitalization, quality of life, and compliance will be recorded and compared between groups to assess the impact of APP-assisted patient management on the quality of MHD blood purification therapy and the prognosis of MHD patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yunfeng Xia Dr
- Phone Number: 86-023-89012687
- Email: yunfengxia0920@126.com
Study Locations
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 400016
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
-
Contact:
- Yunfeng Xia Dr
- Phone Number: 86-23-89012687
- Email: yunfengxia0920@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with stage 5 chronic kidney disease, who have received maintenance hemodialysis for more than 3 months, are aged between 18 and 75 years old, and have regular dialysis three times a week.
- Patients with relatively stable condition, who are able to take care of themselves and willing to cooperate with the study.
- Patients who can understand and proficiently use WeChat and the "Yueya" mini - program used in this study.
Exclusion Criteria:
- Patients with communication barriers or other conditions that prevent them from cooperating with the study.
- Patients who have a history of acute myocardial infarction, cerebral infarction or intracerebral hemorrhage in the past six months.
- Patients who are not willing to actively cooperate with the study.
- Patients with severe liver cirrhosis, active tuberculosis and AIDS.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: APP management group
For the APP management group, according to the specific conditions of patients such as age, gender, primary disease and complications, the "Yueya" mini-program and WeChat will be used to provide individualized and all-weather guidance for dialysis patients in their daily lives, including health knowledge education, diet and exercise guidance, medication supervision, condition monitoring and real-time feedback.
|
Based on patients' specific conditions such as age, gender, primary disease, and complications, the APP-based management will provide individualized and round-the-clock guidance for dialysis patients in their daily lives through the "Yueya" mini-program and WeChat.
This guidance covers various aspects, including health knowledge education, diet and exercise guidance, medication supervision, condition monitoring, and real-time feedback.
|
|
No Intervention: Non-APP management group
For the non-APP management group, the APP mini-program will not be used to guide patients' daily lives, and only the previous routine management methods will be adopted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mortality rate
Time Frame: About 1 year
|
In this study, mortality rate was used as a prognostic indicator.
|
About 1 year
|
|
Hospitalization rate
Time Frame: About 1 year
|
In this study, the hospitalization rate was used as a prognostic indicator.
|
About 1 year
|
|
Kidney Disease Quality of Life
Time Frame: About 1 year
|
Measuring the quality of life of hemodialysis patients through the Kidney Disease Quality of Life-36(KDQOL-36) scale.
If the KDQOL-36 score increases, the quality of life is considered to be improved.
|
About 1 year
|
|
Incidence of cardiovascular events
Time Frame: About 1 year
|
About 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
Other Study ID Numbers
- 1st ChongqingMedicalUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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