MotivationNCT05398432
The Effect of Hemodialysis Treatment on Self-Care Power and Disease Adjustment of Patients
A study testing motivational interview in people with Motivation and Hemodialysis Complication, run by Abdullah Gerçek at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of self-care supported motivational interviewing on patients receiving hemodialysis treatment on self-care power, disease compliance and metabolic variables. The study was completed with 77 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motivation, Hemodialysis Complication, Patient Compliance
- What is being tested?
- motivational interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2020to 15 Mar 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
- Receiving hemodialysis treatment for at least three months at the time of the study,
- HD treatment for 3-4 hours 2 or 3 days a week,
- 18 years old and above,
- Open to communication and cooperation,
- Not visually or hearing impaired,
- Being a reader and writer,
Show all 9Show fewer
- Not having any psychiatric diagnosis and/or not using any psychiatric medication,
- Have not received motivational interviewing training before,
- Individuals who agreed to participate in the study were included in the study.
Who cannot join
- who are under the age of 18,
- Having a communication problem,
- Individuals who did not want to participate in the study or did not want to continue were excluded from the study.ı
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Care Supported Motivational Interviewing on Patients' Self-Care Strength and Disease Adjustment in Patients Receiving Hemodialysis Treatment
The study was conducted to determine the effect of self-care supported motivational interviewing on patients receiving hemodialysis treatment on self-care power, disease compliance and metabolic variables.
The study was completed with 77 patients. In the collection of data; Personal Information Form, Self-Care Strength Scale, Chronic Disease Adjustment Scale and Patient-Specific Metabolic Variables Form were used.
Read the detailed description
The study was conducted as a randomized controlled, repeated measurement, experimental research design.
The research was carried out in Muş Provincial Health Directorate Muş State Hospital Hemodialysis Unit between October 2020 and March 2021. There are 6 nurses, 7 dialysis technicians, 5 assistant health personnel, 2 specialist physicians, 28 patient beds and 28 hemodialysis machines in the hemodialysis unit where the research was conducted. In the hemodialysis unit, there are 1 waiting room where patients and their attendants wait, 4 private rooms and 2 large halls where patients receive hemodialysis treatment. There is no attempt at motivational interviewing in the hemodialysis center where the research was conducted.
The population of the study consisted of 97 patients who received hemodialysis treatment at the Muş Provincial Health Directorate, Muş State Hospital, Hemodialysis Unit on the specified dates. The sample of the research is "G. Using the "Power-3.1.9.2" program and based on similar articles, 80% power was determined at an effect size of 0.70 and it was calculated to have a minimum of 68 subjects in total. In the hemodialysis unit where the research was conducted, 85 patients who met the research criteria and volunteered to participate in the research were formed because 2 patients did not attend hemodialysis treatment regularly, 4 patients did not want to participate in the study, 3 patients had poor general health conditions, 2 patients had hearing problems, and 1 patient was transferred to another dialysis center. . Using the simple random sampling method, 45 patients were assigned to the experimental group and 40 patients to the control group. However, during the research period, the study was completed with 37 patients in the control group, as 40 patients in the experimental group and 3 patients in the control group died due to the death of 2 patients from the experimental group, the death of 2 patients and the transfer of 1 patient to another hemodialysis center during the research period.
- Conditions
- Motivation, Hemodialysis Complication, Patient Compliance
- Being tested
- motivational interview
- Keywords
- hemodialysis, self care, motivational interview
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewOther
After the pre-test data were applied to all patients, before starting the motivational interview seans, the patients were informed about the interview intervals, duration, and how many times they would be held. In the second week, motivational interview seans were started with the patients. seans with patients took place during the hemodialysis seans. A total of 6 seans were held, one seans per week. After the first seans of the self-care supported motivational interview, the "Self-Care and Adaptation to Disease Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Self-care training was given in the first, second and third seans. Motivational interviews were conducted in the fourth, fifth and sixth seans. Motivational interviewing techniques were used for patients to realize their self-care activities. seans were held individually with the patients and each seans lasted approximately 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | The control group did not intervene Receives: Other: motivational interview |
| experiment | Experimental | Initial data were collected after meeting the patients. Then, a total of 6 seans, 1 seans per week, were performed on the patients. Self-care training was given in the 1st, 2nd and 3rd seans. Motivational interviews were conducted in the 4th, 5th and 6th seans. After the first seans of the self-care supported motivational interview, the "Self Care and Adaptation Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Second data were collected from patients after 6 weeks. Follow-up data were collected for 4 weeks without any intervention. Receives: Other: motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
self care power scale
ıt is a scale used to measure an invidual's self-care abilit. the maximum score is 140. the hiğher the score obtained from the scale indicates the hiğh level of self-care ability and power of the invidual.
Measured: 6 week
Secondary outcomes (1)
Chronic Disease Adjustment Scale
The scale was developed to measure the level of compliance of individuals with chronic diseases. The total score that can be obtained from the scale is 125. An increase in the scores obtained from the sub-dimensions and/or the whole scale means that the patients' level of compliance with the disease also increases.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start2 Feb 2020
- Primary completion20 Nov 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotivationStudies 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
- randomized controlled trial design
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdullah Gerçek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdullah Gerçek, Muş Alparslan University
- Investigators
- abdullah gerçek, doktora, Principal investigator, Muş Alparslan Universityserap parlar kılıç, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398432
- Sponsor's protocol ID
- MUŞ ALPARSLAN UNIVERSITY
- Status last verified
- May 2022
- First submitted
- 27 Sep 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no, not shared with other people
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Care Supported Motivational Interviewing on Patients' Self-Care Strength and Disease Adjustment in Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT05398432
- Acronym / sponsor ID
- MUŞ ALPARSLAN UNIVERSITY
- Conditions
- Motivation, Hemodialysis Complication, Patient Compliance
- Keywords
- hemodialysis, self care, motivational interview
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Abdullah GerçekUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 1 Jun 2022 (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.
The study was conducted to determine the effect of self-care supported motivational interviewing on patients receiving hemodialysis treatment on self-care power, disease compliance and metabolic variables.
The study was completed with 77 patients. In the collection of data; Personal Information Form, Self-Care Strength Scale, Chronic Disease Adjustment Scale and Patient-Specific Metabolic Variables Form were used.
Detailed description
The study was conducted as a randomized controlled, repeated measurement, experimental research design.
The research was carried out in Muş Provincial Health Directorate Muş State Hospital Hemodialysis Unit between October 2020 and March 2021. There are 6 nurses, 7 dialysis technicians, 5 assistant health personnel, 2 specialist physicians, 28 patient beds and 28 hemodialysis machines in the hemodialysis unit where the research was conducted. In the hemodialysis unit, there are 1 waiting room where patients and their attendants wait, 4 private rooms and 2 large halls where patients receive hemodialysis treatment. There is no attempt at motivational interviewing in the hemodialysis center where the research was conducted.
The population of the study consisted of 97 patients who received hemodialysis treatment at the Muş Provincial Health Directorate, Muş State Hospital, Hemodialysis Unit on the specified dates. The sample of the research is "G. Using the "Power-3.1.9.2" program and based on similar articles, 80% power was determined at an effect size of 0.70 and it was calculated to have a minimum of 68 subjects in total. In the hemodialysis unit where the research was conducted, 85 patients who met the research criteria and volunteered to participate in the research were formed because 2 patients did not attend hemodialysis treatment regularly, 4 patients did not want to participate in the study, 3 patients had poor general health conditions, 2 patients had hearing problems, and 1 patient was transferred to another dialysis center. . Using the simple random sampling method, 45 patients were assigned to the experimental group and 40 patients to the control group. However, during the research period, the study was completed with 37 patients in the control group, as 40 patients in the experimental group and 3 patients in the control group died due to the death of 2 patients from the experimental group, the death of 2 patients and the transfer of 1 patient to another hemodialysis center during the research period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial design
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Other: motivational interviewThe control group did not intervene |
| experiment | Experimental | Other: motivational interviewInitial data were collected after meeting the patients. Then, a total of 6 seans, 1 seans per week, were performed on the patients. Self-care training was given in the 1st, 2nd and 3rd seans. Motivational interviews were conducted in the 4th, 5th and 6th seans. After the first seans of the self-care supported motivational interview, the "Self Care and Adaptation Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Second data were collected from patients after 6 weeks. Follow-up data were collected for 4 weeks without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Receiving hemodialysis treatment for at least three months at the time of the study,
- HD treatment for 3-4 hours 2 or 3 days a week,
- 18 years old and above,
- Open to communication and cooperation,
- Not visually or hearing impaired,
Key exclusion criteria (3 listed)
- who are under the age of 18,
- Having a communication problem,
- Individuals who did not want to participate in the study or did not want to continue were excluded from the study.ı
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 |
|---|---|---|
| motivational interviewAfter the pre-test data were applied to all patients, before starting the motivational interview seans, the patients were informed about the interview intervals, duration, and how many times they would be held. In the second week, motivational interview seans were started with the patients. seans with patients took place during the hemodialysis seans. A total of 6 seans were held, one seans per week. After the first seans of the self-care supported motivational interview, the "Self-Care and Adaptation to Disease Training Guide" prepared by the researcher in line with the literature was given to the experimental group. Self-care training was given in the first, second and third seans. Motivational interviews were conducted in the fourth, fifth and sixth seans. Motivational interviewing techniques were used for patients to realize their self-care activities. seans were held individually with the patients and each seans lasted approximately 15-20 minutes. | Other | control, experiment |
Primary outcome
self care power scale
Time frame: 6 week
ıt is a scale used to measure an invidual's self-care abilit. the maximum score is 140. the hiğher the score obtained from the scale indicates the hiğh level of self-care ability and power of the invidual.
1 secondary outcome
Chronic Disease Adjustment Scale
Time frame: 6 week
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 1 Jun 2022.
- Individual participant dataSharing planned: No. no, not shared with other people
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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.
abdullah gerçek, doktora principal investigator
Muş Alparslan University
serap parlar kılıç study director
Inonu 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 motivational interview in people with Motivation and Hemodialysis Complication, run by Abdullah Gerçek 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 9 inclusion and 3 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 1 Jun 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 power scale (time frame: 6 week). 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 1 Jun 2022.