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Effect of Educution in Control Nutrition and Fluid Control of Hemodialysis Patient (RCT)

Primary Purpose

End Stage Renal Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education group
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease focused on measuring hemodialysis, education, Health Belief Model, nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zonguldak Atatürk Public Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education group

Control grup

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 1, 2023
Last Updated
January 4, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05682508
Brief Title
Effect of Educution in Control Nutrition and Fluid Control of Hemodialysis Patient
Acronym
RCT
Official Title
Efficiency of Education Based on Health Belief Model in Diet and Fluid Control of Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
hemodialysis, education, Health Belief Model, nursing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant: Patients in the control group
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control grup
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Personal Information Form
Description
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 Outcome Measure Information:
Title
Fluid Control Scale in Haemodialysis Patients
Description
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 Pre-specified Outcome Measures:
Title
Dietary Knowledge Scale of Hemodialysis Patients
Description
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
Title
Scale for Dietary Behaviours in Haemodialysis Patients
Description
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
Title
Clinical Parameter Monitoring Form
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ufuk Demirel
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zonguldak Atatürk Public Hospital
City
Zonguldak
State/Province
Center
ZIP/Postal Code
67030
Country
Turkey

12. IPD Sharing Statement

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

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