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CompletedNCT05682508RCTUpdated Sep 19, 2024

Effect of Educution in Control Nutrition and Fluid Control of Hemodialysis Patient

An interventional study of Education group in End Stage Renal Disease, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Ege University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • End Stage Renal Disease

Keywords

  • hemodialysis
  • education
  • Health Belief Model
  • nursing
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 62 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • That do not meet the inclusion criteria,
  • Those who are included in another training program on the subject
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Education group

    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

  • No intervention
    Control grup

    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

  • OtherEducation group

    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.

06

What researchers measure

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.

    Time frame: up to 1 year

Secondary outcomes

  1. Fluid Control Scale in Haemodialysis Patients

    It was developed by Albayrak Coşar and Çınar (2012) to measure the knowledge, behaviours and attitudes of haemodialysis patients about fluid restriction. The scale was prepared in the form of a 3 point Likert-type scale. The participants were asked to respond to each item as "agree", "indecisive", or "don't agree". When assessing positive items, "agree" was scored 3, "indecisive" 2, and "don't agree" 1. The negative items (6, 7, and 18-24) are reversely scored. The lowest score obtained from the scale is 24 and the highest score is 72. As the score obtained from the scale increases, patients' compliance with fluid control also increases

    Time frame: up to 1 year

Other outcomes

  1. Dietary Knowledge Scale of Hemodialysis Patients

    It was developed by Bulantekin Düzalan and Cınar Pakyuz in 2014. It was developed to evaluate the dietary knowledge of patients with ESRD receiving haemodialysis treatment. The scale consists of 18 items and is 3-point Likert type . The scoring was as follows: True: "1" point; False: "0" points; and I don't know: "0" points. The lowest and highest scores were 0 and 18 points, respectively. The scale consisted of a single sub-dimension and there was one reverse-scored item (12th item). The scale did not contain a cut-off score and the interpretation was "a good level of knowledge" for higher scores.

    Time frame: up to 1 year

  2. Scale for Dietary Behaviours in Haemodialysis Patients

    It was developed by Bulantekin Düzalan and Cınar Pakyuz in 2014. The scale was developed as a five-point Likert scale with these options: "strongly disagree, disagree, not sure, agree, and strongly agree", ranging from 1 to 5 points, respectively. The scale consisted of a single sub-dimension and there were no reverse-scored items. The lowest and highest scores were 13 and 65 points, respectively. The scale did not contain a cut-off score and the interpretation was "a good behavioural status" for higher scores.

    Time frame: up to 1 year

  3. Clinical Parameter Monitoring Form

    The form was prepared by the investigators to record blood pressure, interdialytic weight gain, dry weight, ultrafiltration value and biochemistry values of the patients. The data in the patient file will be used for the relevant laboratory values of the patient and no new tests will be requested.

    Time frame: up to 1 year

07

Study locations

1 site
  • Zonguldak Atatürk Public Hospital
    Zonguldak, Center 67030, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05682508
Lead sponsor
Ege University
Responsible party
Ufuk DEMİREL (Lecturer, Ege University) — Principal investigator
First posted
Jan 12, 2023
Start date
Jun 30, 2022
Primary completion
Mar 20, 2023
Completion
Mar 20, 2023
Last update
Sep 19, 2024

Study contacts

Ufuk Demirel
principal investigator · Ege University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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