NCT06083545

Brief Summary

The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease

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
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

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

July 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

September 25, 2023

Last Update Submit

October 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    2 years

  • 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.

    2 years

  • 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.

    2 years

Interventions

AppBEHAVIORAL

The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.

Also known as: Application

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Services General Hospital

Taipei, Neihu, 115, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 16, 2023

Study Start

July 15, 2023

Primary Completion

July 20, 2025

Study Completion

July 20, 2025

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations