CKD Stage 4NCT06083545
The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
A study testing App in people with CKD Stage 4 and CKD Stage 5, run by yi ting Hsu at 1 site in Taiwan.
Trial summary
The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- CKD Stage 4, CKD Stage 5
- What is being tested?
- App
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 184 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jul 2023to 20 Jul 2025
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The effects of Application intervention on the physiological indicators and low protein diet cognition among the patients with chronic kidney disease
Read the detailed description
The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.
- Conditions
- CKD Stage 4, CKD Stage 5
- Being tested
- App
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppBehavioural
Also called Application
The low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Jul 2023
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage 4Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yi ting Hsu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yi ting Hsu, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083545
- Sponsor's protocol ID
- ting652520
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Application Intervention on the Physiological Indicators and Low Protein Diet Cognition Among the Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06083545
- Acronym / sponsor ID
- ting652520
- Conditions
- CKD Stage 4, CKD Stage 5
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- yi ting HsuUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 16 Oct 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| AppAlso: ApplicationThe low-protein diet app introduces the perceived significant efficacy of low-protein diets for patients with chronic kidney disease. | Behavioural | – |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App in people with CKD Stage 4 and CKD Stage 5, run by yi ting Hsu at 1 site in Taiwan.
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 16 Oct 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basic information (time frame: 2 years). The study lists 3 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 16 Oct 2023.