Diet Therapy in Hemodialysis Patients

January 10, 2024 updated by: Dilan aktepe coşar

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)"
Time Frame: 4 week

"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)"
Time Frame: 4 week
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

This is where you will find people and organizations involved with this study.

Sponsor

Dilan aktepe coşar

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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