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Completed

NCT Number: NCT05187234

The Effect of Education Hemodialysis Patients According to Roy Adaptation Model

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.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli University

Kırklareli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

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.

Primary outcomes

  1. Change from baseline fluid control

    Time frame: At the end of the 1.st and 3 rd month

    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.

  2. Change from baseline in symptom severity in patients

    Time frame: At the end of the 1.st and 3 rd month

    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".

  3. change from baseline quality of life in patients

    Time frame: At the end of the 1.st and 3 rd month

    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').

Secondary outcomes

  1. change from baseline ıntradialytic Weight Gain

    Time frame: At the end of the 1.st and 3 rd month

    Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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