The Influence of Internet + Combined Family Empowerment Management Mode on Treatment Compliance of PATIENTS With CKD

The Influence of Internet + Combined Family Empowerment Management Mode on Treatment Compliance of PATIENTS With CKD and the Relationship Between Psychological Status and Disease Progression

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Internet
• Intervention / Treatment: Other: the family-centered family enabling health management mode; Other: the routine chronic disease management mode

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jie Zheng, Associate professor; Phone Number: +8618636667799; Email: zhengjie@sxmu.edu.cn

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • The Second Hospital of Shanxi Medical University
      • Contact: Jie Zheng, Associate professor; Phone Number: +8618636667799; Email: zhengjie@sxmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Combined with laboratory results, CKD was confirmed

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
combined group	Other: 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.
traditional group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Time Frame
Morisky Medication Adherence Scale	Six months Max
General Self-Efficacy Scale	Six months Max
Self-Rating Anxiety Scale	Six months Max

Collaborators and Investigators

• Sponsor: Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): July 24, 2024
• Study Completion (Estimated): November 24, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Compliance; Self-efficacy; Mental state; Family empowerment management
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2021SLL138

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No