The Effect of Education Hemodialysis Patients According to Roy Adaptation Model

Hemodialysis Clinical Trial

Official title:

The Effect of Education on Fluid Management, Symptom Control and Quality of Life ın Hemodialysis Patients According to Roy Adaptation Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187234
• Other study ID #: KirklareliU
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: December 12, 2020

Study information

• Verified date: December 2021
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was conducted in order to evaluate the effect of the training provided to hemodialysis patients according to Roy Adaptation Model on fluid management, symptom control, and quality of life. The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control) The patients in the experimental group were provided with training based on Roy Adaptation Model, and training booklets were handed out.The control group did not attempt any intervention.

Description:

The most difficult domain for hemodialysis patients is fluid-salt restriction. Patients with inadequate fluid compliance/adherence experience many symptoms that negatively affect their life. The study was carried out as a randomized controlled trial with the participation of 107 patients (53 experimental, 54 control). The data were collected by using "Patient Information From", "Fluid Control in Hemodialysis Patients Scale" (FCHPS), "Dialysis Symptom Index" (DSI), and "Nottingham Health Profile" (NHP). The forms were filled out by having interviews with the patients in the experimental and control groups in the 0th, 1st, and 3rd months. The patients in the experimental group were provided with training based (face to face individual) on Roy Adaptation Model (0th(onset)and 1st month), and training booklets were handed out. The Training was about 30-45 minutes. control group did not attempt any intervention. Routine maintenance of the control and experimental group and continued. When comparing the experimental and control groups, onset 0th month, 1st month and 3rd month measurements were taken into consideration. All scales were administered to the experimental and control groups at month 0 (onset), 1 and 3 months. The data were analyzed by using descriptive statistics methods with NCSS (Number Cruncher Statistical System) 2007 software, Student's t-test, Mann-Whitney U Test, Pearson Chi-square test, Fisher-Freeman-Halton Exact test, Repeated Measures test, Bonferroni testi Significance was accepted as p<0,05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with end-stage chronic kidney disease older than 18 years undergoing routine hemodialysis treatment for at least 3 months having 3 hemodialysis sessions literate volunteered to participate in the study Exclusion Criteria: Patients with acute renal failure previously diagnosed with liver failure and/or malignancy ,patients with New York Heart Society class 3-4 heart failure a history of kidney transplantation

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Other:
• Education
Experimental: intervention group Education and training booklet based on the Roy adaptation model was given to the patients. The training was repeated at the first welcome and after the first month.

Locations

Country	Name	City	State
Turkey	Kirklareli University	Kirklareli

Sponsors (1)

Lead Sponsor	Collaborator
Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline fluid control	Evaluated by "Fluid Control Scale in Hemodialysis Patients". the scale. The lowest score obtained from the scale was 24 and the highest score was 72, and the higher the score, the greater the compliance of the patients with fluid control.	At the end of the 1.st and 3 rd month
Primary	Change from baseline in symptom severity in patients	Evaluated by 'Dialysis Symptom Index' Using this scoring system, the minimum possible total severity score was 0 if none of the 30 symptoms was present and the maximum potential. Score was 150 if all of the 30 symptoms were reported and rated as "very much bothersome". The minimum value is "0" and the maximum value is "150".	At the end of the 1.st and 3 rd month
Primary	change from baseline quality of life in patients	Evaluated by' Nottingham Health Profile'. It includes 38 items divided into six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. for each of the sections range between 0 ('worst health') and 100 ('best health').	At the end of the 1.st and 3 rd month
Secondary	change from baseline intradialytic Weight Gain	Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session	At the end of the 1.st and 3 rd month