FatigueNCT05909891
Treatment Adherence and Fatigue in Iron Deficiency
A study testing Patient training in people with Fatigue and Adherence, Medication, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Iron Deficiency Anemia is an important health problem. Iron deficiency anemia constitutes half of the anemia seen in the world, and children and women constitute the group with iron deficiency anemia in our country. The treatment is iron replacement by oral or parenteral route. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue, Adherence, Medication
- What is being tested?
- Patient training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 6 Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orientation to person, place and time
- Having no problems communicating
- To voluntarily agree to participate in the research
- Being diagnosed with iron deficiency anemia
- Being between the ages of 18-65
- Being able to read and write
- Receiving oral iron medication for at least 1 month
- Those with low Morisky scale motivation score
Who cannot join
- Individuals under the age of 18
- Foreign nationals
- Those with maling disease
- Pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University
Erzurum, None Selected, 25240
About this study
Official title: The Effect of Education Given to Individuals with Iron Deficiency Anemia on Treatment Compliance and Fatigue
Iron Deficiency Anemia is an important health problem. Iron deficiency anemia constitutes half of the anemia seen in the world, and children and women constitute the group with iron deficiency anemia in our country. The treatment is iron replacement by oral or parenteral route. Due to the side effects of the drugs given in the treatment, the patients have difficulty in adapting to the treatment and there is a change in their fatigue levels. It is thought that the education given to the patients will increase their compliance with the treatment. It is thought that patients' hospital admissions and fatigue levels may change in the failure to comply with the treatment.
In this study, the effect of the education given on the treatment compliance and fatigue of the patients will be investigated. This research will help patients with iron deficiency anemia whether they need education, the importance of treatment compliance and their fatigue levels.
Read the detailed description
Iron Deficiency Anemia (DEA) is one of the acquired anemia, which is seen as a result of insufficient intake of iron necessary for the body or rapid decrease in iron stores. It is the most common anemia in the world and constitutes 50% of anemias. It is stated that the incidence is increasing in low-income societies. In studies on adults, the frequency of IDA is around 20%, and it is most commonly seen in women due to pregnancy and menstruation.
The aim of the "Turkey Like Iron" program, which was started in our country in 2004, is to try to prevent iron deficiency anemia as new generations are the adults of the future. The most common findings in patients with iron deficiency anemia are fatigue, weakness, activity intolerance, hair loss and thinning, thinning-breaking-flattening of nails, and headache. The reason for fatigue, which is one of these symptoms, is the decrease in the amount of oxygen carried to the tissues as a result of the low hemoglobin level in the blood. Depending on the inability to carry enough oxygen to the muscles, activity intolerance occurs in people. The degree of anemia affects the severity of fatigue. The severity of fatigue also affects the person's ability to perform activities of daily living. Oral or parenteral iron replacements are used in the treatment of anemia that causes fatigue and activity intolerance. However, some side effects may be seen in patients due to the use of oral iron drugs. These side effects are stated as tooth discoloration, nausea, vomiting, indigestion, constipation, diarrhea, and darkening of stool color. Patients cannot continue treatment due to these side effects. Trainings given to patients to increase adherence to treatment can be effective in coping with the treatment process and side effects. It is stated that the symptoms experienced by the patients who continue the treatment will decrease in a short time such as 1 month. However, it was stated by the experts that the treatment should be continued for 3-6 months in order to replace the iron stores. When the increase in the hemoglobin values of the patients who continue the treatment and the oxygen carried to the tissues reach a sufficient level, the symptoms such as fatigue and activity intolerance will decrease and disappear over time.
Considering the authorities and responsibilities of the nursing profession, one of the most important is to provide training in line with the needs of the patient and their relatives. Nurses provide training to individuals in order to protect and improve the health of the individual, family and society, and to gain the right health behaviors to improve in case of illness. From past to present, training given to patients by healthcare professionals increases patients' adherence to treatment.
- Conditions
- Fatigue, Adherence, Medication
- Being tested
- Patient training
- Keywords
- fatigue, education, anemia, adherence
- Medical subject headings
- Fatigue, Medication Adherence, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient trainingOther
A training booklet will be created by scanning the literature on iron deficiency anemia. The training booklet will be evaluated in terms of content and readability, according to the DISCERN measurement tool, while obtaining expert opinion.
The training period will be at least 35-40 minutes, taking into account the educational status of the patient and explaining the importance of compliance with the treatment. After the training, when the patients come to the routine check-ups in the 1st and 2nd months, the level of compliance with the treatment and the fatigue of the patients will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patient selection will be made according to the planned randomization after examining the inclusion and exclusion criteria.
Introductory Form, Morisky Scale and Fatigue Scale will be applied to the individuals in the experimental group included in the study. The same forms will be applied to the patients included in the control group. Individuals in the control group will be followed up by the hospital routinely.
In addition to the routine follow-ups for the patients in the experimental group, the training material created by the researchers will be individually presented as an average of 35-40 minutes, and a session will be given in the form of mutual question and answer. After the training, a sample booklet, which is the training material, will be given to the patient as a reminder.
Adaptation and fatigue tests will be re-applied at the first control of the patients after the training. Receives: Other: Patient training |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morisky Medication Adherence Scale (MMAS 4)
The scale was developed in 1986 by Morisky et al. to evaluate adherence to antihypertensive drug treatment. The validity and reliability study of the Morisky Adherence to Medication Scale, which is used in many studies for chronic diseases, was conducted by Yılmaz (2004) for our country to measure adherence to antipsychotic treatment. Muslu used this scale to evaluate adherence to treatment in schizophrenia patients in 2010. The scale has a 4-question design that can evaluatethe motivation and knowledge levels separately to evaluate adherence to long-term drug treatment in chronic diseases. The questions of the scale are answered as "Yes/No", and "Yes" is calculated as "0" points and "No" as "1" points. The highest total score obtained from the scale is "4", and as the score increases, treatment adherencealso increases. The score obtained from the scale indicates adherence to treatment as 0-1 = Low level, 2-3 = Moderate level, and 4 = High
Measured: avarage of six mounth
Visual Similarity Scale for Fatigue
The Turkish validity and reliability scale was made by Yurtsever, and it was created by Lee et al. (1990) in 1990. The scale consists of 18 items, fatigue (1. 2. 3. 4. 5. 11. 12. 13. 14. 15. 16. 17. and 18. items) and energy level (6. 7. 8. 9 and 10. items) consists of sub-dimensions. There are 10 cm lines in each statement of the scale, and there is a positive statement at one end of the line and a negative statement at the other. These statements are scored between 0 and 10. The items of the fatigue subscale range from the most positive to the most negative, while the items of the energy subscale range from the most negative to the most positive. An increase in the fatigue subscale score indicates an increase in the severity of fatigue, and an increase in the energy subscale score indicates an increase in energy. Getting a high score on the fatigue questions and a low score on the energy questions indicate that the severity of fatigue is high.
Measured: avarage of six mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Polat, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909891
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/416
- Status last verified
- Jan 2025
- First submitted
- 9 Jun 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Houston BL, Hurrie D, Graham J, Perija B, Rimmer E, Rabbani R, Bernstein CN, Turgeon AF, Fergusson DA, Houston DS, Abou-Setta AM, Zarychanski R. Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 5;8(4):e019240. doi: 10.1136/bmjopen-2017-019240.
PubMed 29626044Jogu P, Kamran MT. Iron-Deficiency Anemia. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448065/
PubMed 28846348Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
PubMed 26408108
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Individuals with Iron Deficiency Anemia on Treatment Compliance and Fatigue
- ClinicalTrials.gov ID
- NCT05909891
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/416
- Conditions
- Fatigue, Adherence, Medication
- Keywords
- fatigue, education, anemia, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 18 Jun 2023 (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.
Iron Deficiency Anemia is an important health problem. Iron deficiency anemia constitutes half of the anemia seen in the world, and children and women constitute the group with iron deficiency anemia in our country. The treatment is iron replacement by oral or parenteral route. Due to the side effects of the drugs given in the treatment, the patients have difficulty in adapting to the treatment and there is a change in their fatigue levels. It is thought that the education given to the patients will increase their compliance with the treatment. It is thought that patients' hospital admissions and fatigue levels may change in the failure to comply with the treatment.
In this study, the effect of the education given on the treatment compliance and fatigue of the patients will be investigated. This research will help patients with iron deficiency anemia whether they need education, the importance of treatment compliance and their fatigue levels.
Detailed description
Iron Deficiency Anemia (DEA) is one of the acquired anemia, which is seen as a result of insufficient intake of iron necessary for the body or rapid decrease in iron stores. It is the most common anemia in the world and constitutes 50% of anemias. It is stated that the incidence is increasing in low-income societies. In studies on adults, the frequency of IDA is around 20%, and it is most commonly seen in women due to pregnancy and menstruation.
The aim of the "Turkey Like Iron" program, which was started in our country in 2004, is to try to prevent iron deficiency anemia as new generations are the adults of the future. The most common findings in patients with iron deficiency anemia are fatigue, weakness, activity intolerance, hair loss and thinning, thinning-breaking-flattening of nails, and headache. The reason for fatigue, which is one of these symptoms, is the decrease in the amount of oxygen carried to the tissues as a result of the low hemoglobin level in the blood. Depending on the inability to carry enough oxygen to the muscles, activity intolerance occurs in people. The degree of anemia affects the severity of fatigue. The severity of fatigue also affects the person's ability to perform activities of daily living. Oral or parenteral iron replacements are used in the treatment of anemia that causes fatigue and activity intolerance. However, some side effects may be seen in patients due to the use of oral iron drugs. These side effects are stated as tooth discoloration, nausea, vomiting, indigestion, constipation, diarrhea, and darkening of stool color. Patients cannot continue treatment due to these side effects. Trainings given to patients to increase adherence to treatment can be effective in coping with the treatment process and side effects. It is stated that the symptoms experienced by the patients who continue the treatment will decrease in a short time such as 1 month. However, it was stated by the experts that the treatment should be continued for 3-6 months in order to replace the iron stores. When the increase in the hemoglobin values of the patients who continue the treatment and the oxygen carried to the tissues reach a sufficient level, the symptoms such as fatigue and activity intolerance will decrease and disappear over time.
Considering the authorities and responsibilities of the nursing profession, one of the most important is to provide training in line with the needs of the patient and their relatives. Nurses provide training to individuals in order to protect and improve the health of the individual, family and society, and to gain the right health behaviors to improve in case of illness. From past to present, training given to patients by healthcare professionals increases patients' adherence to treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Patient trainingPatient selection will be made according to the planned randomization after examining the inclusion and exclusion criteria. Introductory Form, Morisky Scale and Fatigue Scale will be applied to the individuals in the experimental group included in the study. The same forms will be applied to the patients included in the control group. Individuals in the control group will be followed up by the hospital routinely. In addition to the routine follow-ups for the patients in the experimental group, the training material created by the researchers will be individually presented as an average of 35-40 minutes, and a session will be given in the form of mutual question and answer. After the training, a sample booklet, which is the training material, will be given to the patient as a reminder. Adaptation and fatigue tests will be re-applied at the first control of the patients after the training. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Orientation to person, place and time
- Having no problems communicating
- To voluntarily agree to participate in the research
- Being diagnosed with iron deficiency anemia
- Being between the ages of 18-65
Key exclusion criteria (4 listed)
- Individuals under the age of 18
- Foreign nationals
- Those with maling disease
- Pregnant
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 |
|---|---|---|
| Patient trainingA training booklet will be created by scanning the literature on iron deficiency anemia. The training booklet will be evaluated in terms of content and readability, according to the DISCERN measurement tool, while obtaining expert opinion. The training period will be at least 35-40 minutes, taking into account the educational status of the patient and explaining the importance of compliance with the treatment. After the training, when the patients come to the routine check-ups in the 1st and 2nd months, the level of compliance with the treatment and the fatigue of the patients will be evaluated. | Other | Experimental Group |
Primary outcome
Morisky Medication Adherence Scale (MMAS 4)
Time frame: avarage of six mounth
The scale was developed in 1986 by Morisky et al. to evaluate adherence to antihypertensive drug treatment. The validity and reliability study of the Morisky Adherence to Medication Scale, which is used in many studies for chronic diseases, was conducted by Yılmaz (2004) for our country to measure adherence to antipsychotic treatment. Muslu used this scale to evaluate adherence to treatment in schizophrenia patients in 2010. The scale has a 4-question design that can evaluatethe motivation and knowledge levels separately to evaluate adherence to long-term drug treatment in chronic diseases. The questions of the scale are answered as "Yes/No", and "Yes" is calculated as "0" points and "No" as "1" points. The highest total score obtained from the scale is "4", and as the score increases, treatment adherencealso increases. The score obtained from the scale indicates adherence to treatment as 0-1 = Low level, 2-3 = Moderate level, and 4 = High
Visual Similarity Scale for Fatigue
Time frame: avarage of six mounth
The Turkish validity and reliability scale was made by Yurtsever, and it was created by Lee et al. (1990) in 1990. The scale consists of 18 items, fatigue (1. 2. 3. 4. 5. 11. 12. 13. 14. 15. 16. 17. and 18. items) and energy level (6. 7. 8. 9 and 10. items) consists of sub-dimensions. There are 10 cm lines in each statement of the scale, and there is a positive statement at one end of the line and a negative statement at the other. These statements are scored between 0 and 10. The items of the fatigue subscale range from the most positive to the most negative, while the items of the energy subscale range from the most negative to the most positive. An increase in the fatigue subscale score indicates an increase in the severity of fatigue, and an increase in the energy subscale score indicates an increase in energy. Getting a high score on the fatigue questions and a low score on the energy questions indicate that the severity of fatigue is high.
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 17 Jan 2025.
- Background: PubMed 29626044Houston BL, Hurrie D, Graham J, Perija B, Rimmer E, Rabbani R, Bernstein CN, Turgeon AF, Fergusson DA, Houston DS, Abou-Setta AM, Zarychanski R. Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomised controlled trials. BMJ Open. 2018 Apr 5;8(4):e019240. doi: 10.1136/bmjopen-2017-019240.
- Background: PubMed 28846348Jogu P, Kamran MT. Iron-Deficiency Anemia. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448065/
- Background: PubMed 26408108Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient training in people with Fatigue and Adherence, Medication, run by Ataturk 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 8 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 17 Jan 2025. 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?
Morisky Medication Adherence Scale (MMAS 4) (time frame: avarage of six mounth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909891, which also lists 3 linked publications.
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 17 Jan 2025.