The Effect of Education Hemodialysis Patients According to Roy Adaptation Model

Sponsor
Kırklareli University (Other)
Overall Status
Completed
CT.gov ID
NCT05187234
Collaborator
(none)
107
1
2
12.1
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Education
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Education on Fluid Management, Symptom Control and Quality of Life ın Hemodialysis Patients According to Roy Adaptation Model
Actual Study Start Date :
Dec 9, 2019
Actual Primary Completion Date :
Dec 12, 2020
Actual Study Completion Date :
Dec 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline fluid control [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 [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 [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 Outcome Measures

  1. change from baseline ıntradialytic Weight Gain [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kırklareli University Kırklareli Turkey

Sponsors and Collaborators

  • Kırklareli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özlem Özdemir, PhD, Kırklareli University
ClinicalTrials.gov Identifier:
NCT05187234
Other Study ID Numbers:
  • KırklareliU
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Özlem Özdemir, PhD, Kırklareli University

Study Results

No Results Posted as of Jan 11, 2022