InternetNCT06167668
The Influence of Internet + Combined Family Empowerment Management Mode on Treatment Compliance of PATIENTS With CKD
An observational study of Internet and Chronic Kidney Disease, run by Shanxi Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Internet, Chronic Kidney Disease
- What is being tested?
- the routine chronic disease management mode and the family-centered family enabling health management mode
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 24 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Adult
Study population: Combined with laboratory results, CKD was confirmed
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Jie Zheng, Associate professor, +8618636667799, zhengjie@sxmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Internet, Chronic Kidney Disease
- Being tested
- the routine chronic disease management mode, the family-centered family enabling health management mode
- Keywords
- Compliance, Self-efficacy, Family empowerment management, Mental state
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the routine chronic disease management modeOther
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 modeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| combined group | Not described Receives: Other: the family-centered family enabling health management mode | |
| traditional group | Not described Receives: Other: the routine chronic disease management mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Six months Max
General Self-Efficacy Scale
Measured: Six months Max
Self-Rating Anxiety Scale
Measured: Six months Max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start23 Nov 2023
- Primary completion24 Jul 2024 (estimated)
- Study completion24 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InternetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Jie, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167668
- Sponsor's protocol ID
- 2021SLL138
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06167668
- Acronym / sponsor ID
- 2021SLL138
- Conditions
- Internet, Chronic Kidney Disease
- Keywords
- Compliance, Self-efficacy, Family empowerment management, Mental state
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 24 Jul 2024 (estimated)
- Study completion
- 24 Nov 2024 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined group | – | Other: the family-centered family enabling health management mode |
| traditional group | – | Other: the routine chronic disease management mode |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Combined with laboratory results, CKD was confirmed
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the routine chronic disease management modeindoor 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 | Other | traditional group |
| the family-centered family enabling health management modeThe specific measures were as follows :(1) intervention group construction. (2) Online knowledge promotion. (3) Disease assessment.(4) Medication guidance reminder.(5) Enabling psychological counseling. | Other | combined group |
Primary outcome
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.
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.
3 secondary outcomes
Morisky Medication Adherence Scale
Time frame: Six months Max
General Self-Efficacy Scale
Time frame: Six months Max
Self-Rating Anxiety Scale
Time frame: Six months Max
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internet and Chronic Kidney Disease, run by Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zheng, Associate professor (+8618636667799, zhengjie@sxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.