The Effect of Education Hemodialysis Patients According to Roy Adaptation Model
The Effect of Education on Fluid Management, Symptom Control and Quality of Life ın Hemodialysis Patients According to Roy Adaptation Model
1 other identifier
interventional
107
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
1 active site
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
December 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2020
CompletedFirst Submitted
Initial submission to the registry
December 24, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedJanuary 11, 2022
December 1, 2021
1 year
December 24, 2021
December 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
change from baseline ıntradialytic Weight Gain
At the end of the 1.st and 3 rd month
Study Arms (2)
Education
EXPERIMENTALExperimental: intervention group The patients were interviewed 3 times, initially at the 1st month and at the 3rd month. All forms were initially administered to patients in the intervention group. Patients were randomly assigned to the intervention group and participated in a one-on-one Roy Adaptation Model-based training program consisting of an initial 30-45 minute session. Hemodialysis Patient Education Manual prepared by the researchers was applied to the patients in the intervention group during the training. All forms were re-administered to the patients in the intervention group in the 1st and 3rd months.
Control
NO INTERVENTIONEducation and training manual based on the Roy adaptation model was not given to the patients.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kırklareli University
Kırklareli, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 24, 2021
First Posted
January 11, 2022
Study Start
December 9, 2019
Primary Completion
December 12, 2020
Study Completion
December 12, 2020
Last Updated
January 11, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share