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

NCT05897502 | Completed DMC

• 1 other identifier: EMRP-112-047
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

End-Stage Kidney Disease; Hyperphosphatemia

Keywords

hemodialysis,nutrition education,The Transtheoretical Model

Outcome Measures

Primary Outcomes (21)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  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.

  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.

  Baseline and the six month

Secondary Outcomes (15)

• Change from Baseline in the diet of knowledge form at the third month

  Baseline and the third month

• Change from Baseline in the diet of knowledge form at the fourth month

  Baseline and the fourth month

• Change from Baseline in the diet of knowledge form at the sixth month

  Baseline and the sixth month

• Change from Baseline in the diet of attitude form at the third month

  Baseline and the third month

• Change from Baseline in the diet of attitude form at the fourth month

  Baseline and the fourth month

Study Arms (2)

the theoretical model nutritional education

EXPERIMENTAL

instruction with multimedia

Behavioral: multimedia education

control

PLACEBO COMPARATOR

instruction with traditional paper

Behavioral: multimedia education

Interventions

multimedia education 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.

Also known as: instruction with traditional paper

control; the theoretical model nutritional education

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinical diagnosis of Alzheimer's Disease
• Malignant tumors, gastrointestinal cachexia, and catheterization

Sponsors & Collaborators

• Liu, Liu-Yin: lead

Study Sites (1)

Liu liu.yin

Kaohsiung City, 84402, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 26843138 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperphosphatemia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• liu-yin Liu

  The Nursing department of EDAHospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant does not know who the intervention group is versus the control group
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: July 4, 2023
• Primary Completion: July 17, 2023
• Study Completion: February 29, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)