- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06083545
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
October 11, 2023 updated by: yi ting Hsu
The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.
Study Type
Interventional
Enrollment (Estimated)
184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Neihu
-
Taipei, Neihu, Taiwan, 115
- Tri-Services General Hospital
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 20 years or above and agree to participate in the research
- Conscious, literate and able to communicate in Mandarin and Taiwanese
- Have the ability to use vehicles
- Kidney disease stage is 3b as calculated by the MDRD formula From stage 5 to stage 5, he has not yet received alternative therapy and is diagnosed as a patient with chronic kidney disease by a nephrologist.
Exclusion Criteria:
- Blindness
- Cognitive abnormalities diagnosed by a doctor as dementia or mental disorder
- People who have no ability to act independently and are assisted by others in daily life
- Patients with nephrotic syndrome are excluded.
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
basic information
Time Frame: 2 years
|
Gender, age, education level, living status, financial resources, employment status, time of suffering from kidney disease, stage of kidney disease, time of nephrology treatment, combined chronic diseases, number of health education sessions by health teachers and nutritionists.
|
2 years
|
|
physiological index
Time Frame: 2 years
|
It is an index for regular tracking and testing of research subjects.
Information is provided by the laboratory department of the hospital of the research subjects.
It mainly tracks serum potassium, phosphorus, sodium, calcium, and eGFR.
|
2 years
|
|
ow protein diet awareness scale
Time Frame: 2 years
|
This scale was developed with reference to the Chronic Kidney Disease Health Management Manual of the Ministry of Health and Welfare (2018), with a total of 7 questions.
It is scored as "true", "wrong" and "don't know", calculated on a scale of 0 to 1, with the highest It is 7 points, with forward and reverse questions.
The higher the score, the more correct the understanding of low-protein diet.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 15, 2023
Primary Completion (Estimated)
July 20, 2025
Study Completion (Estimated)
July 20, 2025
Study Registration Dates
First Submitted
September 25, 2023
First Submitted That Met QC Criteria
October 11, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ting652520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.
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