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

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

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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