Diet Therapy in Hemodialysis Patients

The Effect of Hemodialysis Patients' Attitudes Towards Diet Therapy on Dialysis Symptoms: A Randomized Controlled Clinical Study

This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.

Study Overview

• Status: Completed
• Conditions: Healthy; Hemolysis; Diet; Symptoms and Signs
• Intervention / Treatment: Behavioral: diet therapy training

Detailed Description

Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kelkit
    • Gümüşhane, Kelkit, Turkey, 2900
      • Gümüşhane Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Being ≥18 years old,

• Agreeing to participate in the research,
• Being literate,
• Being able to communicate verbally,
• Receiving outpatient HD treatment three sessions a week at the same institution,
• No impairment in mental and cognitive functions,
• Has been receiving HD treatment for at least three months (to be defined as a chronic HD program)

Exclusion Criteria:

• Refusal to participate in the research,
• Being on peritoneal dialysis,
• Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
• The general condition (hemodynamically) is unstable (heart rate < 100 mm/Hg or diastolic BP< 60 mm/Hg),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group where diet education is given; Patients in the experimental group were given face-to-face diet education by the researcher in the waiting room for approximately 15 minutes and an "Information Brochure" was given. Pre-training (pre-test) for hemodialysis patients Data collection tools were applied. All data collection tools were applied to these patients, except for the structured Patient Information Form for post-training measurements (intermediate measurement) 1 month after the training was given.	Behavioral: diet therapy training; diet education; Other Names: Group without diet education
No Intervention: Control group; No treatment was performed on hemodialysis patients in this group. Only data collection forms were applied to the patients before the study (pretest), at the 1st week (intermediate measurement/1st measurement) and at the end of the study. (8th week) 3 times in total for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodialysis Patients' Attitude Scale Towards Diet Therapy (HDTO)"	"HDTÖ" (HD Dietary Attitude Scale): Each item is scored as 1-Strongly Agree, 2-Agree, 3-Disagree, 4-Strongly Disagree. The scale comprises three sub-dimensions:	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Dialysis Symptom Index (DSI)"	this scale assesses the emotional and physical symptoms of dialysis patients and the severity of these symptoms, consisting of a total of 30 items	4 week

Collaborators and Investigators

• Sponsor: Dilan aktepe coşar
• Investigators: Principal Investigator: Dilan aktepe coşar, lecture, Gümüşhane Universıty

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Healthy; Diet; Hemolysis; Symptoms and Signs
• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis
• Other Study ID Numbers: Hm20231001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No