The Effect of Education Hemodialysis Patients According to Roy Adaptation Model

NCT ID: NCT05187234

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2020-12-12

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.

Detailed 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.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Education

Experimental: 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.

Group Type: EXPERIMENTAL

Education

Intervention Type: 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.

Control

Education and training manual based on the Roy adaptation model was not given to the patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kırklareli University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Özdemir

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kırklareli University

Kırklareli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KırklareliU

Identifier Type: -

Identifier Source: org_study_id