Back to resultsThe Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
Primary Purpose
CKD Stage 4, CKD Stage 5
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
App
Sponsored by
About this trial
This is an interventional health services research trial for CKD Stage 4
Eligibility Criteria
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.
Sites / Locations
- Tri-Services General Hospital
Outcomes
Primary Outcome Measures
basic information
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.
physiological index
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.
ow protein diet awareness scale
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06083545
Brief Title
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
Official Title
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
July 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yi ting Hsu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease
Detailed Description
The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CKD Stage 4, CKD Stage 5
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
App
Other Intervention Name(s)
Application
Intervention Description
The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.
Primary Outcome Measure Information:
Title
basic information
Description
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.
Time Frame
2 years
Title
physiological index
Description
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.
Time Frame
2 years
Title
ow protein diet awareness scale
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tri-Services General Hospital
City
Taipei
State/Province
Neihu
ZIP/Postal Code
115
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
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