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

December 17, 2023 updated by: Zheng Jie, Shanxi Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • The Second Hospital of Shanxi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
blood urea nitrogen
Time Frame: 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.
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
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Morisky Medication Adherence Scale
Time Frame: Six months Max
Six months Max
General Self-Efficacy Scale
Time Frame: Six months Max
Six months Max
Self-Rating Anxiety Scale
Time Frame: Six months Max
Six months Max

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings