NCT05682508

Brief Summary

Hemodialysis patients are required to adhere to diet and fluid restriction. The literature shows that hemodialysis patients have low adherence to diet and fluid restriction. Failure to adhere to fluid control increases weight gain between two dialysis sessions. Increased weight gain between two dialysis sessions can lead to signs and symptoms, such as heart failure, hypertension, edema and dyspnea. Ultrafiltration is increased during dialysis to remove excess fluid from the body between two dialysis sessions. As a result, this leads to large changes in the patient's weight during dialysis sessions, leading to hemodialysis complications such as hypotension and muscle cramps. Diet is important to prevent uremic complication for hemodialysis patient. Diet restriction purposes to minimize uremic symptoms and fluid- electrolyte imbalance. As increase failure to adhere diet, serum phosphorus serum potassium rise and weight gain between two dialysis sessions increases. As a result, problems with the cardiac system, respiratory system and bones are experienced. Diet and fluid restriction helps to prevent complications, to increase the quality of life and to reduce mortality. Therefore, diet and fluid control vitally important for hemodialysis patients. Nurses have an important place in providing diet and fluid management. Desired success can be achieved in fluid and diet control by giving planned trainings to patients by nurses. In patient education, the Health Belief Model is used as an effective guide, which explains the reason for the person's attitudes and behaviors. This model is based on explain why did the patient not adhere with the treatment and what motivates the patient. The model is based on the premise that they will change their behavior when people understand the severity of the illness. The Health Belief Model can used education on diet and fluid contol of hemodialysis patients. In this study, Health Belief Model components will be used as a guide in the preparation of the educational content to be given to hemodialysis patients. With this study planned to be done; it was aimed to determine the effect of Health Belief Model-based education on diet and fluid control of hemodialysis patients. The study was planned as a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 1, 2023

Last Update Submit

September 12, 2024

Conditions

Keywords

hemodialysiseducationHealth Belief Modelnursing

Outcome Measures

Primary Outcomes (1)

  • Personal Information Form

    It was prepared by the researchers by analysing the relevant literature. In the personal information form, socio-demographic and disease information of the patient were questioned.

    up to 1 year

Secondary Outcomes (1)

  • Fluid Control Scale in Haemodialysis Patients

    up to 1 year

Other Outcomes (3)

  • Dietary Knowledge Scale of Hemodialysis Patients

    up to 1 year

  • Scale for Dietary Behaviours in Haemodialysis Patients

    up to 1 year

  • Clinical Parameter Monitoring Form

    up to 1 year

Study Arms (2)

Education group

EXPERIMENTAL

The training planned four step. In the first interview, a pre-test will be applied by the researcher. The patient will then be trained and given a training booklet. The second interview will take place 30 days after the end of the first training. The topics will be summarised and the benefits of adherence to diet and fluid control will be emphasised. The third interview will be held 30 days after the second interview. In this interview, the patient's questions will be answered and the necessary training sections will be explained again for patient. The issues that prevent the patient from complying with fluid and diet control will be discussed with the patient and positive developments in the patient prognosis will be reinforced. The last interview will be held 30 days after the third interview. In all interviews, data will be collected with data collection tools and clinical parameters of the patient will be recorded.

Other: Education group

Control grup

NO INTERVENTION

No training will be given to the control group. In the first interview will be applied data collection tools and will be recorded clinical parameters. Last interview with control group will be held 90 days after first interview. Data collection tools will be applied and clinical parameters will be recorded in last interview. The training booklet will be given also to patients in control group at the end of the research.

Interventions

Based on the Health Belief Model, a "educational booklet on diet and fluid control in individuals receiving hemodialysis treatment" has been prepared. The training content consists of information on the structure and function of the kidneys, information about chronic renal failure, possible complications in case of non-adherence with the desired fluid control and diet, perceived benefits, the information on diet and fluid control consisted of perceived benefits, barriers, coping with barriers, perceived susceptibility in this regard, and information on the development of self-efficacy to improve dietary compliance and fluid control. Individuals in the education group were given individual training by the researcher. The training was conducted in a single meeting of 20-30 minutes in the first hour when haemodialysis started and the patient's condition was stable.

Education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • He is over 18 years old,
  • At least 6 months of hemodialysis treatment,
  • At least primary school graduate,
  • Does not have a condition that interferes with language, hearing or visual communication,
  • Patients who accept to participate in the study are included in the study

You may not qualify if:

  • Those who are included in another training program on the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Atatürk Public Hospital

Zonguldak, Center, 67030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ufuk Demirel

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant: Patients in the control group
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 12, 2023

Study Start

June 30, 2022

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

September 19, 2024

Record last verified: 2023-01

Locations