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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06167668
Other study ID # 2021SLL138
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 23, 2023
Est. completion date November 24, 2024

Study information

Verified date December 2023
Source Shanxi Medical University
Contact Jie Zheng, Associate professor
Phone +8618636667799
Email zhengjie@sxmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore the effect of Internet + combined family empowerment management mode on treatment compliance of patients with chronic kidney disease (CKD) and the correlation between psychological status and disease progression.


Description:

To explore the effect of Internet + combined family empowerment management mode on treatment compliance of patients with chronic kidney disease (CKD) and the correlation between psychological status and disease progression. A total of 100 patients with CKD treated in our hospital from October 2020 to October 2021 were screened and analyzed, and randomly divided into combined group and traditional group according to the number table method, with 50 patients in each group. The traditional group was implemented with the conventional chronic disease management mode, and the combined group was implemented with the Internet + combined family empowerment management mode. The differences in compliance, self-efficacy, psychological status and renal function indexes of each group were compared. Mmas-8 compliance score and GSES score showed an increasing trend. Compared with the traditional group, T2-T4MMAS-8 score and GSES score in the combined group were significantly increased with statistical differences (P < 0.05). The levels of BUN, Scr, SAS and SDS showed a decreasing trend. Compared with the traditional group, the levels of four indexes T2-T4 in the combined group were significantly decreased with statistical differences (P < 0.05). BUN, Scr were positively correlated with SAS and SDS (P< 0.05). Internet + combined family empowerment management model can effectively improve renal function, negative psychological clarity, self-efficacy and medication compliance of CKD patients, which is worthy of clinical promotion.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 24, 2024
Est. primary completion date July 24, 2024
Accepts healthy volunteers
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Enrolled subjects meet the diagnostic criteria for CKD and are confirmed to be CKD based on laboratory findings. - After assessment, it was determined that the subject's communication was barrier-free - No abnormal feedback was found after evaluation. - The patient received dialysis treatment for more than 3 months, and the clinical data were complete. This is the first time they've been to the hospital. Exclusion criteria: - The female patient is pregnant and lactating. - Kidney transplant patient. - People with language communication disorders or mental diseases. - Participants received other psychological guidance and health education interventions during the study period.

Study Design


Intervention

Other:
the routine chronic disease management mode
indoor temperature and humidity adjustment, regular ventilation and hygiene of ward and clinic environment, promotion of patients' health awareness by distributing disease brochures, regular inspection of wards, and home nursing and health guidance based on disease knowledge when discharged
the family-centered family enabling health management mode
The specific measures were as follows :(1) intervention group construction. (2) Online knowledge promotion. (3) Disease assessment.(4) Medication guidance reminder.(5) Enabling psychological counseling.

Locations

Country Name City State
China The Second Hospital of Shanxi Medical University Taiyuan Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood urea nitrogen 5ml of fasting elbow vein was collected from patients in the morning at four study observation time points from T1 to T4, and Z206A table top medical centrifuge produced by HERMLE, Germany, was centrifuged at a speed of 1500 r/min for 0.5h to extract upper serum, which was placed in a refrigerator at -70? for detection. 70/5000 The four observation time points in this study were 1 day before treatment, 1 month, 3 months, and 6 months after treatment, labeled T1 to T4, respectively. T1 ~ T4 when fasting in the morning.
Primary serum creatinine 5ml of fasting elbow vein was collected from patients in the morning at four study observation time points from T1 to T4, and Z206A table top medical centrifuge produced by HERMLE, Germany, was centrifuged at a speed of 1500 r/min for 0.5h to extract upper serum, which was placed in a refrigerator at -70? for detection. 70/5000 The four observation time points in this study were 1 day before treatment, 1 month, 3 months, and 6 months after treatment, labeled T1 to T4, respectively. T1 ~ T4 when fasting in the morning.
Secondary Morisky Medication Adherence Scale Six months Max
Secondary General Self-Efficacy Scale Six months Max
Secondary Self-Rating Anxiety Scale Six months Max
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