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

End Stage Renal Disease Clinical Trial

— RCT  

Official title:

Efficiency of Education Based on Health Belief Model in Diet and Fluid Control of Hemodialysis Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05682508
• Other study ID #: 2021/15
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 62
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• That do not meet the inclusion criteria,

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Education 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.

Locations

Country	Name	City	State
Turkey	Zonguldak Atatürk Public Hospital	Zonguldak	Center

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary Knowledge Scale of Hemodialysis Patients	It was developed by Bulantekin Düzalan and Cinar 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.	up to 1 year
Other	Scale for Dietary Behaviours in Haemodialysis Patients	It was developed by Bulantekin Düzalan and Cinar 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.	up to 1 year
Other	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.	up to 1 year
Primary	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	Fluid Control Scale in Haemodialysis Patients	It was developed by Albayrak Cosar and Çinar (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	up to 1 year