NCT05187234

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 24, 2021

Last Update Submit

December 24, 2021

Conditions

Keywords

fluid management,symptom control,life quality

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

EXPERIMENTAL

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

Control

NO INTERVENTION

Education 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.

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

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

Locations