Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

NCT ID: NCT05897502

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-02-29

Brief Summary

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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

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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

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End-Stage Kidney Disease Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The participant does not know who the intervention group is versus the control group

Study Groups

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the theoretical model nutritional education

instruction with multimedia

Group Type EXPERIMENTAL

multimedia education

Intervention Type BEHAVIORAL

The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses.

The control group use routine education.

control

instruction with traditional paper

Group Type PLACEBO_COMPARATOR

multimedia education

Intervention Type BEHAVIORAL

The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses.

The control group use routine education.

Interventions

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multimedia education

The experimental group use multimedia education, 20 minute nutrition education courses each time, a total of 8 courses.

The control group use routine education.

Intervention Type BEHAVIORAL

Other Intervention Names

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instruction with traditional paper

Eligibility Criteria

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Inclusion Criteria

1. the biochemical value ≥ 5.5 mg/dl or albumin value\<3.8g/dL
2. BMI\<23kg/m2
3. Unexpected weight loss.
4. Must be able to swallow tablets

Exclusion Criteria

1. Clinical diagnosis of Alzheimer's Disease
2. Malignant tumors, gastrointestinal cachexia, and catheterization
Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liu, Liu-Yin

OTHER

Sponsor Role lead

Responsible Party

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Liu, Liu-Yin

Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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liu-yin Liu

Role: PRINCIPAL_INVESTIGATOR

The Nursing department of EDAHospital

Locations

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Liu liu.yin

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 26843138 (View on PubMed)

Related Links

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https://consumer.fda.gov.tw

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.

Other Identifiers

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EMRP-112-047

Identifier Type: -

Identifier Source: org_study_id

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