Hemodialysis ComplicationNCT04797234
The Effect of Patient Education Based on Nursing Model on Life Activities and Self-Care of Hemodialysis Patients
A study testing Experiment in people with Hemodialysis Complication, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2020to 8 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Roper, Logan and Tierney Nursing Model Based Patient Education Program on the Daily Living Activities and Self-Care Power of Hemodialysis Patients
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.
Read the detailed description
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. CRF is an irreversible, progressive disease involving many systems. Its treatment is kidney transplant or dialysis. CRF affects 10-15% of adults worldwide. In other words, one out of every six adults has CRF. 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 as of 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 person on the dialysis machine, the healthcare team and the family in the treatment programs that last three days a week, an average of 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 whose CRF result is due to hemodialysis, 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, 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. In the "Nursing Model" developed by RLT based on the Life Model, they focused on providing nursing care based on human characteristics, believed in the necessity of observations and measurable events and activities, and based their nursing services on these beliefs. 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. In this study, it is planned to evaluate the effect of the education given to individuals receiving hemodialysis based on Roper, Logan-Tierney's Nursing Model on the level of independence and self-care ability in daily living activities.
Research for the development of the nursing profession contributes to the knowledge of nursing science by developing and testing nursing models / theories. In the literature, it is seen that the use of the Nursing Model of RLT is limited only by mentioning the content of the theory in certain parts of the study rather than reflecting it on the whole study. There are no extensive explanations about the model and enough information about how it can be used in practice. It has been determined that postgraduate studies conducted using the Nursing Model of RLT are mostly descriptive studies. However, nursing theories and models should be used effectively in research and practice. When the studies on individuals who receive hemodialysis treatment are examined, it has been determined that the use of the Nursing Model of RLT is very low. It is predicted that the patient education program created using this Nursing Model will support the increase of the independence levels and self-care abilities of individuals who receive hemodialysis treatment.
At the end of the patient education program based on the Nursing Model of RLT, individuals who receive hemodialysis treatment will increase their independence levels and self-care abilities in daily living activities. It will be ensured that caregiving healthcare professionals perform hemodialysis treatment with less stress.
- Conditions
- Hemodialysis Complication
- Being tested
- Control, Experiment
- Keywords
- education, hemodialysis, life model, self-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
There will be no intervention to the control group.
ExperimentOther
The experimental group will be trained for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | There will be no intervention to the control group. Receives: Other: Control |
| Experiment | Experimental | The experimental group will be trained for 6 weeks. Receives: Other: Experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Modified Barthel Index
The Modified Barthel Index is a comprehensive scale that can be used to measure patients' physical abilities. The total score that can be obtained from the Modified Barthel Index is between 0 and 100, with 0 points showing full dependency and 100 points showing full independence.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start16 Dec 2020
- Primary completion6 Feb 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdulsamed Kaya, Principal investigator, MUS ALPARLAN UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797234
- Sponsor's protocol ID
- 10879717-050.01.04
- Status last verified
- May 2022
- First submitted
- 10 Mar 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Roper, Logan and Tierney Nursing Model Based Patient Education Program on the Daily Living Activities and Self-Care Power of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04797234
- Acronym / sponsor ID
- 10879717-050.01.04
- Conditions
- Hemodialysis Complication
- Keywords
- education, hemodialysis, life model, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. CRF is an irreversible, progressive disease involving many systems. Its treatment is kidney transplant or dialysis. CRF affects 10-15% of adults worldwide. In other words, one out of every six adults has CRF. 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 as of 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 person on the dialysis machine, the healthcare team and the family in the treatment programs that last three days a week, an average of 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 whose CRF result is due to hemodialysis, 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, 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. In the "Nursing Model" developed by RLT based on the Life Model, they focused on providing nursing care based on human characteristics, believed in the necessity of observations and measurable events and activities, and based their nursing services on these beliefs. 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. In this study, it is planned to evaluate the effect of the education given to individuals receiving hemodialysis based on Roper, Logan-Tierney's Nursing Model on the level of independence and self-care ability in daily living activities.
Research for the development of the nursing profession contributes to the knowledge of nursing science by developing and testing nursing models / theories. In the literature, it is seen that the use of the Nursing Model of RLT is limited only by mentioning the content of the theory in certain parts of the study rather than reflecting it on the whole study. There are no extensive explanations about the model and enough information about how it can be used in practice. It has been determined that postgraduate studies conducted using the Nursing Model of RLT are mostly descriptive studies. However, nursing theories and models should be used effectively in research and practice. When the studies on individuals who receive hemodialysis treatment are examined, it has been determined that the use of the Nursing Model of RLT is very low. It is predicted that the patient education program created using this Nursing Model will support the increase of the independence levels and self-care abilities of individuals who receive hemodialysis treatment.
At the end of the patient education program based on the Nursing Model of RLT, individuals who receive hemodialysis treatment will increase their independence levels and self-care abilities in daily living activities. It will be ensured that caregiving healthcare professionals perform hemodialysis treatment with less stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlThere will be no intervention to the control group. |
| Experiment | Experimental | Other: ExperimentThe experimental group will be trained for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlThere will be no intervention to the control group. | Other | Control |
| ExperimentThe experimental group will be trained for 6 weeks. | Other | Experiment |
Primary outcome
Self-Care Ability Scale
Time frame: 6 weeks
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.
1 secondary outcome
Modified Barthel Index
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulsamed Kaya principal investigator
MUS ALPARLAN UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment in people with Hemodialysis Complication, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care Ability Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.