NCT06167668

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

December 4, 2023

Last Update Submit

December 17, 2023

Conditions

Keywords

ComplianceSelf-efficacyFamily empowerment managementMental state

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Morisky Medication Adherence Scale

    Six months Max

  • General Self-Efficacy Scale

    Six months Max

  • Self-Rating Anxiety Scale

    Six months Max

Study Arms (2)

combined group

Other: the family-centered family enabling health management mode

traditional group

Other: the routine chronic disease management mode

Interventions

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

traditional group

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.

combined group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Combined with laboratory results, CKD was confirmed

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicPatient Compliance

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Jie Zheng, Associate professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

November 23, 2023

Primary Completion

July 24, 2024

Study Completion

November 24, 2024

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations