End-Stage Kidney DiseaseNCT05897502
Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis
A study testing multimedia education in people with End-Stage Kidney Disease and Hyperphosphatemia, run by Liu, Liu-Yin at 1 site in Taiwan.
Trial summary
The purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- End-Stage Kidney Disease, Hyperphosphatemia
- What is being tested?
- multimedia education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jul 2023to 29 Feb 2024
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the biochemical value ≥ 5.5 mg/dl or albumin value<3.8g/dL
- BMI<23kg/m2
- Unexpected weight loss.
- Must be able to swallow tablets
Who cannot join
- Clinical diagnosis of Alzheimer's Disease
- Malignant tumors, gastrointestinal cachexia, and catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis
The purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients
Read the detailed description
After being informed about the study and potential risks, all patients giving written Informed consent will undergo a 1-week screening period to determine eligibility For study entry. At week 0, eligible patients will be assigned to the intervention group and the control group by single-blind manner(participant) with convenience sampling. In the intervention group, the patients were trained in The Transtheoretical Model on nutritional education for 8 weeks. In the control group, the patients were trained in roution nutrition education.
- Conditions
- End-Stage Kidney Disease, Hyperphosphatemia
- Being tested
- multimedia education
- Keywords
- hemodialysis,nutrition education,The Transtheoretical Model
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimedia educationBehavioural
Also called instruction with traditional paper
The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses.
The control group use routine education.
| Study group | Role | What they receive |
|---|---|---|
| the theoretical model nutritional education | Experimental | instruction with multimedia Receives: Behavioral: multimedia education |
| control | Placebo comparator | instruction with traditional paper Receives: Behavioral: multimedia education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Biochemical value (Albumine) at the third month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Measured: Baseline and the third month
Change from Baseline in Biochemical value (Albumine) at the fourth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Measured: Baseline and the fourth month
Change from Baseline in Biochemical value (Albumine) at the sixth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Measured: Baseline and the sixth month
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Measured: Baseline and the third month
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Measured: Baseline and the fourth month
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Measured: Baseline and the sitxth month
Change from Baseline in Biochemical value(cholesterol )at the third month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Measured: Baseline and the third month
Change from Baseline in Biochemical value(cholesterol )at the fourth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Measured: Baseline and the fourth month
Change from Baseline in Biochemical value(cholesterol )at the sixth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Measured: Baseline and and the sixth month
Change from Baseline in Biochemical value(creatine)at the third month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Measured: Baseline and the third month
Change from Baseline in Biochemical value(creatine) at the fourth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Measured: Baseline and the fourth month
Change from Baseline in Biochemical value(creatine) at the sixth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Measured: Baseline and the sixth month
Change from Baseline in Biochemical value( Phosphate) at the third month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Measured: Baseline and the third month
Change from Baseline in Biochemical value( Phosphate) at the fourth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Measured: Baseline and the fourth month
Change from Baseline in Biochemical value( Phosphate) at the sixth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Measured: Baseline and the sixth month
Change from Baseline in body measurement ( Hand grip strength ) at the third month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Measured: Baseline and the third month
Change from Baseline in body measurement ( Hand grip strength ) at the fourth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Measured: Baseline and the fourth month
Change from Baseline in body measurement ( Hand grip strength ) at the sixth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Measured: Baseline and the sixth month
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Measured: Baseline and the third month
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Measured: Baseline and the fourth month
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Measured: Baseline and the six month
Secondary outcomes (15)
Change from Baseline in the diet of knowledge form at the third month
The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge
Measured: Baseline and the third month
Change from Baseline in the diet of knowledge form at the fourth month
The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge
Measured: Baseline and the fourth month
Change from Baseline in the diet of knowledge form at the sixth month
The diet of knowledge form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 10 points. The higher the score, the positive performance on healthy diet knowledge
Measured: Baseline and the sixth month
Change from Baseline in the diet of attitude form at the third month
The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating
Measured: Baseline and the third month
Change from Baseline in the diet of attitude form at the fourth month
The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating
Measured: Baseline and the fourth month
Change from Baseline in the diet of attitude form at the sixth month
The diet of attitude form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive attitude towards healthy eating
Measured: Baseline and the sixth month
Change from Baseline in the diet of behavior form at the third month
The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior
Measured: Baseline and the third month
Change from Baseline in the diet of behavior form at the fourth month
The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior
Measured: Baseline and the fourth month
Change from Baseline in the diet of behavior form at the sixth month
The diet of behavior form is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 20 points. A higher score indicates a positive performance on healthy eating behavior
Measured: Baseline and the sixth month
Change from Baseline in the high phosphorus food frequency questionnaire at the third month
The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.
Measured: Baseline and the third month
Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month
The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.
Measured: Baseline and the fourth month
Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month
The high phosphorus food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,The full score is 42. The higher the score, the negative the frequency of food intake with high phosphorus.
Measured: Baseline and the sixth month
Change from Baseline in the six major food frequency questionnaire at the third month
The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies
Measured: Baseline and the third month
Change from Baseline in the six major food frequency questionnaire at the fourth month
The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies
Measured: Baseline and the fourth month
Change from Baseline in the six major food frequency questionnaire at the sixth month
The six major food frequency questionnaire is a validated self-reported instrument to assess the eating habits of hemodialysis patients,Full score is 12 points. A higher score indicates a balanced performance on the six major food intake frequencies
Measured: Baseline and the sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start4 Jul 2023
- Primary completion17 Jul 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-Stage Kidney DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The research design explores the evaluation of intervention effectiveness through a parallel group and experimental research design. Intentionally select experimental and control groups. A single blinding design (participants). The experimental group used multi-media education, 20 minutes per session, total 8 courses. The control group received routine education. The Principal investigator explains the research purpose to eligible participant, and signs a consent form. The interviewer conducted data: basic information and nutritional status indicators (mini nutritional assessment scale, dietary knowledge, attitude, behavior scale, simple dietary intake frequency scale) of two groups of hemodialysis patients as the Baseline. After 8-week nutritional education by dialysis nursing staff. Post tests (dietary knowledge, attitude, behavior scale, mini nutritional assessment scale, simple dietary intake frequency scale) were conducted by interviewer at the 3rd, 4th, and 5th months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu, Liu-Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu, Liu-Yin, E-DA Hospital
- Investigators
- liu-yin Liu, Principal investigator, The Nursing department of EDAHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897502
- Sponsor's protocol ID
- EMRP-112-047
- Status last verified
- Feb 2024
- First submitted
- 18 May 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the privacy and confidentiality factors of the subjects' personal data
Publications
Karavetian M, Elzein H, Rizk R, Jibai R, de Vries N. Nutritional education for management of osteodystrophy: Impact on serum phosphorus, quality of life, and malnutrition. Hemodial Int. 2016 Jul;20(3):432-40. doi: 10.1111/hdi.12405. Epub 2016 Feb 3.
PubMed 26843138
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 34-Week Single-Blind Trial of Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT05897502
- Acronym / sponsor ID
- EMRP-112-047
- Conditions
- End-Stage Kidney Disease, Hyperphosphatemia
- Keywords
- hemodialysis,nutrition education,The Transtheoretical Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Liu, Liu-YinUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 Jun 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 purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients
Detailed description
After being informed about the study and potential risks, all patients giving written Informed consent will undergo a 1-week screening period to determine eligibility For study entry. At week 0, eligible patients will be assigned to the intervention group and the control group by single-blind manner(participant) with convenience sampling. In the intervention group, the patients were trained in The Transtheoretical Model on nutritional education for 8 weeks. In the control group, the patients were trained in roution nutrition education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research design explores the evaluation of intervention effectiveness through a parallel group and experimental research design. Intentionally select experimental and control groups. A single blinding design (participants). The experimental group used multi-media education, 20 minutes per session, total 8 courses. The control group received routine education. The Principal investigator explains the research purpose to eligible participant, and signs a consent form. The interviewer conducted data: basic information and nutritional status indicators (mini nutritional assessment scale, dietary knowledge, attitude, behavior scale, simple dietary intake frequency scale) of two groups of hemodialysis patients as the Baseline. After 8-week nutritional education by dialysis nursing staff. Post tests (dietary knowledge, attitude, behavior scale, mini nutritional assessment scale, simple dietary intake frequency scale) were conducted by interviewer at the 3rd, 4th, and 5th months.
| Arm | Type | Receives |
|---|---|---|
| the theoretical model nutritional education | Experimental | Behavioral: multimedia educationinstruction with multimedia |
| control | Placebo comparator | Behavioral: multimedia educationinstruction with traditional paper |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the biochemical value ≥ 5.5 mg/dl or albumin value<3.8g/dL
- BMI<23kg/m2
- Unexpected weight loss.
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Clinical diagnosis of Alzheimer's Disease
- Malignant tumors, gastrointestinal cachexia, and catheterization
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 |
|---|---|---|
| multimedia educationAlso: instruction with traditional paperThe experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses. The control group use routine education. | Behavioural | control, the theoretical model nutritional education |
Primary outcome
Change from Baseline in Biochemical value (Albumine) at the third month
Time frame: Baseline and the third month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value (Albumine) at the fourth month
Time frame: Baseline and the fourth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value (Albumine) at the sixth month
Time frame: Baseline and the sixth month
Biochemical value (Albumine) is a validated to assess the nutritional status of hemodialysis, less than 3.8gm/dl is considered malnutrition
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the third month
Time frame: Baseline and the third month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the fourth month
Time frame: Baseline and the fourth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in Biochemical value( normalized protein catabolic rate) at the sixth month
Time frame: Baseline and the sitxth month
Biochemical value( normalized protein catabolic rate) is a validated to assess the nutritional status of hemodialysis, normal value greater than 1.2gm/day/k
Change from Baseline in Biochemical value(cholesterol )at the third month
Time frame: Baseline and the third month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value(cholesterol )at the fourth month
Time frame: Baseline and the fourth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value(cholesterol )at the sixth month
Time frame: Baseline and and the sixth month
Biochemical value( cholesterol) is a validated to assess the nutritional status of hemodialysis, less than 100mg/dl is considered malnutrition
Change from Baseline in Biochemical value(creatine)at the third month
Time frame: Baseline and the third month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in Biochemical value(creatine) at the fourth month
Time frame: Baseline and the fourth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in Biochemical value(creatine) at the sixth month
Time frame: Baseline and the sixth month
Biochemical value(creatine) is a validated to assess the nutritional status of hemodialysis, less than 8-10 mg/dl before hemodialysis indicates malnutrition
Change from Baseline in Biochemical value( Phosphate) at the third month
Time frame: Baseline and the third month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in Biochemical value( Phosphate) at the fourth month
Time frame: Baseline and the fourth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in Biochemical value( Phosphate) at the sixth month
Time frame: Baseline and the sixth month
Biochemical value(Phosphate) is a validated to assess the nutritional status of hemodialysis, normal value is 2.7-4.5 mg/dL
Change from Baseline in body measurement ( Hand grip strength ) at the third month
Time frame: Baseline and the third month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in body measurement ( Hand grip strength ) at the fourth month
Time frame: Baseline and the fourth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in body measurement ( Hand grip strength ) at the sixth month
Time frame: Baseline and the sixth month
Hand grip strength is a validated to assess the nutritional status of hemodialysis, male ≤ 30 kilograms, female ≤ 20 kilograms, indicating a risk of frailty
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the third month
Time frame: Baseline and the third month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the fourth month
Time frame: Baseline and the fourth month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
Change from Baseline in (Mini Nutritional Assessment-Short Form, MNA-SF) at the sixth month
Time frame: Baseline and the six month
(Mini Nutritional Assessment-Short Form, MNA-SF) is a validated self-reported instrument to assess the nutritional status of hemodialysis,Out of 14 points. ≤11 points malnutrition risk. ≤7 points malnutrition.
15 secondary outcomes
Change from Baseline in the diet of knowledge form at the third month
Time frame: Baseline and the third month
Change from Baseline in the diet of knowledge form at the fourth month
Time frame: Baseline and the fourth month
Change from Baseline in the diet of knowledge form at the sixth month
Time frame: Baseline and the sixth month
Change from Baseline in the diet of attitude form at the third month
Time frame: Baseline and the third month
Change from Baseline in the diet of attitude form at the fourth month
Time frame: Baseline and the fourth month
Change from Baseline in the diet of attitude form at the sixth month
Time frame: Baseline and the sixth month
Change from Baseline in the diet of behavior form at the third month
Time frame: Baseline and the third month
Change from Baseline in the diet of behavior form at the fourth month
Time frame: Baseline and the fourth month
Change from Baseline in the diet of behavior form at the sixth month
Time frame: Baseline and the sixth month
Change from Baseline in the high phosphorus food frequency questionnaire at the third month
Time frame: Baseline and the third month
Change from Baseline in the high phosphorus food frequency questionnaire at the fourth month
Time frame: Baseline and the fourth month
Change from Baseline in the high phosphorus food frequency questionnaire at the sixth month
Time frame: Baseline and the sixth month
Change from Baseline in the six major food frequency questionnaire at the third month
Time frame: Baseline and the third month
Change from Baseline in the six major food frequency questionnaire at the fourth month
Time frame: Baseline and the fourth month
Change from Baseline in the six major food frequency questionnaire at the sixth month
Time frame: Baseline and the sixth month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Results publication: PubMed 26843138Karavetian M, Elzein H, Rizk R, Jibai R, de Vries N. Nutritional education for management of osteodystrophy: Impact on serum phosphorus, quality of life, and malnutrition. Hemodial Int. 2016 Jul;20(3):432-40. doi: 10.1111/hdi.12405. Epub 2016 Feb 3.
- I will refer to the food composition analysis in the materials, and the part about phosphorus and protein will be the basis of the research.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Based on the privacy and confidentiality factors of the subjects' personal data
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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.
liu-yin Liu principal investigator
The Nursing department of EDAHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimedia education in people with End-Stage Kidney Disease and Hyperphosphatemia, run by Liu, Liu-Yin 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 2 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: finished, as of the sponsor's last update on 17 May 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Biochemical value (Albumine) at the third month (time frame: Baseline and the third month). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897502, which also lists 1 linked publication.
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 17 May 2024.