Diet Therapy in Hemodialysis Patients

NCT06215339 | Completed

• 1 other identifier: Hm20231001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemolysis; Diet; Symptoms and Signs; Healthy

Keywords

Hemolysis; Diet; Healthy; Symptoms and Signs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• "Dialysis Symptom Index (DSI)"

  4 week

Study Arms (2)

group where diet education is given

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

diet therapy training BEHAVIORAL

diet education

Also known as: Group without diet education

group where diet education is given

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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),

Sponsors & Collaborators

• Dilan aktepe coşar: lead

Study Sites (1)

Gümüşhane Üniversitesi

Gümüşhane, Kelkit, 2900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemolysis; Signs and Symptoms

Interventions

Population Groups; Nutrition Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dilan aktepe coşar, lecture

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While the patients were randomized; In order to keep the possibility of being affected by each other at a minimum level, the study was continued with the same application group in the same session group. For example; It's like working only with the robot cat group in the 08:00-12:00 session group on Mondays. In order to reduce the possibility of selection bias due to sample selection, "single-stage cluster type random sampling", which is a subtype of random sampling, was used. In addition, before the study, patients were informed about the study and their consent was obtained.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: using G\*Power 3.1.9.2. The sample size was deemed sufficient (experiment=30; control=30), and the study was concluded. Participants were selected using a lottery method, and data were collected through a singleblind randomization process.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 22, 2024
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)