HemolysisNCT06215339
Diet Therapy in Hemodialysis Patients
A study testing diet therapy training in people with Hemolysis and Diet, run by Dilan aktepe coşar at 1 site in Turkey (Türkiye).
Trial summary
This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemolysis, Diet, Symptoms and Signs
- What is being tested?
- diet therapy training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2023
- 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
- Being ≥18 years old,
- Agreeing to participate in the research,
- Being literate,
- Being able to communicate verbally,
- Receiving outpatient HD treatment three sessions a week at the same institution,
- No impairment in mental and cognitive functions,
- Has been receiving HD treatment for at least three months (to be defined as a chronic HD program)
Who cannot join
- Refusal to participate in the research,
- Being on peritoneal dialysis,
- Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
- The general condition (hemodynamically) is unstable (heart rate < 100 mm/Hg or diastolic BP< 60 mm/Hg),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane Üniversitesi
Gümüşhane, Kelkit, 2900
About this study
Official title: The Effect of Hemodialysis Patients' Attitudes Towards Diet Therapy on Dialysis Symptoms: A Randomized Controlled Clinical Study
This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.
Read the detailed description
Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.
- Conditions
- Hemolysis, Diet, Symptoms and Signs, Healthy
- Being tested
- diet therapy training
- Keywords
- Hemolysis, Diet, Healthy, Symptoms and Signs
- Medical subject headings
- Hemolysis, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet therapy trainingBehavioural
Also called Group without diet education
diet education
| Study group | Role | What they receive |
|---|---|---|
| group where diet education is given | Experimental | Patients in the experimental group were given face-to-face diet education by the researcher in the waiting room for approximately 15 minutes and an "Information Brochure" was given.
Pre-training (pre-test) for hemodialysis patients Data collection tools were applied. All data collection tools were applied to these patients, except for the structured Patient Information Form for post-training measurements (intermediate measurement) 1 month after the training was given. Receives: Behavioral: diet therapy training |
| Control group | No intervention | No treatment was performed on hemodialysis patients in this group. Only data collection forms were applied to the patients before the study (pretest), at the 1st week (intermediate measurement/1st measurement) and at the end of the study. (8th week) 3 times in total for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodialysis Patients' Attitude Scale Towards Diet Therapy (HDTO)"
"HDTÖ" (HD Dietary Attitude Scale):
Each item is scored as 1-Strongly Agree, 2-Agree, 3-Disagree, 4-Strongly Disagree. The scale comprises three sub-dimensions:
Measured: 4 week
Secondary outcomes (1)
"Dialysis Symptom Index (DSI)"
this scale assesses the emotional and physical symptoms of dialysis patients and the severity of these symptoms, consisting of a total of 30 items
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- using G\*Power 3.1.9.2. The sample size was deemed sufficient (experiment=30; control=30), and the study was concluded. Participants were selected using a lottery method, and data were collected through a singleblind randomization process.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilan aktepe coşar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilan aktepe coşar, Gümüşhane Universıty
- Investigators
- Dilan aktepe coşar, lecture, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215339
- Sponsor's protocol ID
- Hm20231001
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hemodialysis Patients' Attitudes Towards Diet Therapy on Dialysis Symptoms: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06215339
- Acronym / sponsor ID
- Hm20231001
- Conditions
- Hemolysis, Diet, Symptoms and Signs, Healthy
- Keywords
- Hemolysis, Diet, Healthy, Symptoms and Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dilan aktepe coşarUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Jan 2024 (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.
This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.
Detailed description
Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- using G*Power 3.1.9.2. The sample size was deemed sufficient (experiment=30; control=30), and the study was concluded. Participants were selected using a lottery method, and data were collected through a singleblind randomization process.
| Arm | Type | Receives |
|---|---|---|
| group where diet education is given | Experimental | Behavioral: diet therapy trainingPatients in the experimental group were given face-to-face diet education by the researcher in the waiting room for approximately 15 minutes and an "Information Brochure" was given. Pre-training (pre-test) for hemodialysis patients Data collection tools were applied. All data collection tools were applied to these patients, except for the structured Patient Information Form for post-training measurements (intermediate measurement) 1 month after the training was given. |
| Control group | No intervention | –No treatment was performed on hemodialysis patients in this group. Only data collection forms were applied to the patients before the study (pretest), at the 1st week (intermediate measurement/1st measurement) and at the end of the study. (8th week) 3 times in total for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being ≥18 years old,
- Agreeing to participate in the research,
- Being literate,
- Being able to communicate verbally,
- Receiving outpatient HD treatment three sessions a week at the same institution,
Key exclusion criteria (4 listed)
- Refusal to participate in the research,
- Being on peritoneal dialysis,
- Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
- The general condition (hemodynamically) is unstable (heart rate < 100 mm/Hg or diastolic BP< 60 mm/Hg),
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 |
|---|---|---|
| diet therapy trainingAlso: Group without diet educationdiet education | Behavioural | group where diet education is given |
Primary outcome
Hemodialysis Patients' Attitude Scale Towards Diet Therapy (HDTO)"
Time frame: 4 week
"HDTÖ" (HD Dietary Attitude Scale): Each item is scored as 1-Strongly Agree, 2-Agree, 3-Disagree, 4-Strongly Disagree. The scale comprises three sub-dimensions:
1 secondary outcome
"Dialysis Symptom Index (DSI)"
Time frame: 4 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 22 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Dilan aktepe coşar, lecture principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet therapy training in people with Hemolysis and Diet, run by Dilan aktepe coşar 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 7 inclusion and 4 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 22 Jan 2024. 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?
Hemodialysis Patients' Attitude Scale Towards Diet Therapy (HDTO)" (time frame: 4 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 22 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.