NCT04797234

Brief Summary

Chronic Renal Failure (CRF); The result of a decrease in the glomerular filtration value is defined as a chronic and progressive deterioration in the fluid-solute balance of the kidney and metabolic-endocrine functions. Treatment is kidney transplant or dialysis. CRF affects 10-15% of adults worldwide. CRF rate in the general adult population in Turkey is 15.7%. According to the data of the Turkish Nephrology Association, renal replacement therapy (RRT) is applied to a total of 77,311 patients in our country by the end of 2017. The most common (76%) applied RRT type is hemodialysis treatment. In individuals receiving hemodialysis treatment, nausea-vomiting, weakness, fatigue, itching, fluid-solute imbalances, hypotension and pain can be seen due to uremia. This situation reduces the functionality of the patient and the limitation of physical activities brings physical and psycho-social effects with it. The dependence of the individual on the dialysis machine, the healthcare team and the family in treatment programs that last three days a week, on average four hours a day, affects the personal lives of the patients. It can be said that nursing care and education are of great importance in resolving the existing or potential problems of patients who are dependent on hemodialysis as a result of CRF, and in adapting patients to life with their disease. It is the nursing theories that will guide these attempts of nurses. Because nursing theories interpret and define the profession; thus helping nurses in training, practice and research activities as a professional. Nursing Model of Roper, Logan-Tierney (RLT), one of the important theories of nursing, is based on the life model. In this model, the main purpose of nursing is to ensure that people are informed so that they can lead a quality and healthy life. This model, which can be integrated into all service areas of the health care system and handles individual-centered care with a humanistic and holistic approach, supports the participation of the individual in care. It is predicted that the patient education program created using the Nursing Model of RLT will support the increase of the independence levels and self-care abilities of individuals who receive hemodialysis treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

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 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2021

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

March 10, 2021

Last Update Submit

May 20, 2022

Conditions

Keywords

educationhemodialysislife modelself-care

Outcome Measures

Primary Outcomes (1)

  • Self-Care Ability Scale

    It is a scale used to measure an individual's self-care ability or self-care ability. The maximum score is 140. The higher the score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual.

    6 weeks

Secondary Outcomes (1)

  • Modified Barthel Index

    6 weeks

Study Arms (2)

Control

EXPERIMENTAL

There will be no intervention to the control group.

Other: Control

Experiment

EXPERIMENTAL

The experimental group will be trained for 6 weeks.

Other: Experiment

Interventions

ControlOTHER

There will be no intervention to the control group.

Control

The experimental group will be trained for 6 weeks.

Experiment

Eligibility Criteria

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

You may qualify if:

  • years of age and over, who agree to participate in the research, Receiving hemodialysis for 4 hours 3 days a week,
  • Having received hemodialysis treatment for at least 1 year and continuing the treatment,
  • Without cognitive, affective and mental limitations,
  • It will create all hemodialysis patients who do not have a communication problem regarding vision and hearing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mus Alparlan University

Muş, 49250, Turkey (Türkiye)

Location

Study Officials

  • Abdulsamed Kaya

    MUS ALPARLAN UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is carried out to evaluate the effects of the education given to individuals who receive hemodialysis treatment based on Roper, Logan - Tierney's Nursing Model on the independence level and self-care power of the sick individuals in their daily living activities. The research is planned to be conducted as a randomized controlled study determined by simple random method, two groups, pretest - posttest, and experimental research design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

December 16, 2020

Primary Completion

February 6, 2021

Study Completion

May 8, 2021

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations