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Treatment Adherence and Fatigue in Iron Deficiency

Primary Purpose

Fatigue, Adherence, Medication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient training
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring fatigue, education, anemia, adherence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Individuals under the age of 18 Foreign nationals Those with maling disease Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Modified Morisky Scale
    The scale was created by Morisky et al. (1986) in 1986 to evaluate adherence to antihypertensive drug therapy. Validity and reliability of the Modified Morisky Scale used in many studies for chronic diseases Vural et al. (2012) by The scale consists of 6 questions to evaluate adherence to long-term drug therapy in chronic diseases and can evaluate motivation and knowledge level separately. Scale questions are answered as Yes/No, and yes 1 point, no 0 point; in other questions, yes is calculated as 0 points and no as 1 point. If the total score obtained from questions 1,2 and 6 of the scale is 0 or 1, it indicates low motivation level, and >1 indicates high motivation level. If the total score obtained from the 3,4 and 5 questions of the scale is 0 or 1, it indicates low knowledge level, and >1 indicates high knowledge level.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    June 9, 2023
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05909891
    Brief Title
    Treatment Adherence and Fatigue in Iron Deficiency
    Official Title
    The Effect of Education Given to Individuals With Iron Deficiency Anemia on Treatment Compliance and Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 (Internal Medicine Nursing Book with Case Scenarios, 2019; Turkey Program Guide as Iron). The treatment is iron replacement by oral or parenteral route (Guzelcuk, Ozbek, 2017). 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 (Guzelcuk, Özbek, 2017; Guide, 2019; Çipil, Demircioğlu, 2016). 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 (Internal Medicine Nursing Book with Case Scenarios, 2019). It is the most common anemia in the world and constitutes 50% of anemias (Internal Medicine Nursing Book with Case Scenarios, 2019). It is stated that the incidence is increasing in low-income societies (As Iron Turkey Program Guide; Erduran ,2010). In studies on adults, the frequency of IDA is around 20%, and it is most commonly seen in women due to pregnancy and menstruation (Iron Deficiency and Iron Deficiency Anemia Clinical Protocol, 2020). 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 (As Iron Turkey Program Guide). 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 (Dağ, Kıyak, 2021; Guide, 2019). 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 (Dağ, Kıyak, 2021). Depending on the inability to carry enough oxygen to the muscles, activity intolerance occurs in people (Dağ, Kıyak, 2021). The degree of anemia affects the severity of fatigue (Dağ, Kıyak, 2021). The severity of fatigue also affects the person's ability to perform activities of daily living (Ovayolu, Ovayolu, 2017). Oral or parenteral iron replacements are used in the treatment of anemia that causes fatigue and activity intolerance (Kılavuz, 2019). However, some side effects may be seen in patients due to the use of oral iron drugs (Kılavuz,2019; Çipil, Demircioğlu, 2016). These side effects are stated as tooth discoloration, nausea, vomiting, indigestion, constipation, diarrhea, and darkening of stool color (Kılavuz, 2019; Çipil, Demircioğlu, 2016). Patients cannot continue treatment due to these side effects (Kılavuz,2019; Çipil, Demircioğlu, 2016). Trainings given to patients to increase adherence to treatment can be effective in coping with the treatment process and side effects (Aydemir Geduk, 2018). It is stated that the symptoms experienced by the patients who continue the treatment will decrease in a short time such as 1 month (Çipil, Demircioğlu, 2016; Bolaman, 2004). However, it was stated by the experts that the treatment should be continued for 3-6 months in order to replace the iron stores (Guide, 2019). 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 (Kılavuz, 2019; Dağ, Kıyak, 2021). 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 (Aydemir Geduk, 2018). From past to present, training given to patients by healthcare professionals increases patients' adherence to treatment (Yel, Kardadakovan, 2021).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, Adherence, Medication
    Keywords
    fatigue, education, anemia, adherence

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Patient training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Modified Morisky Scale
    Description
    The scale was created by Morisky et al. (1986) in 1986 to evaluate adherence to antihypertensive drug therapy. Validity and reliability of the Modified Morisky Scale used in many studies for chronic diseases Vural et al. (2012) by The scale consists of 6 questions to evaluate adherence to long-term drug therapy in chronic diseases and can evaluate motivation and knowledge level separately. Scale questions are answered as Yes/No, and yes 1 point, no 0 point; in other questions, yes is calculated as 0 points and no as 1 point. If the total score obtained from questions 1,2 and 6 of the scale is 0 or 1, it indicates low motivation level, and >1 indicates high motivation level. If the total score obtained from the 3,4 and 5 questions of the scale is 0 or 1, it indicates low knowledge level, and >1 indicates high knowledge level.
    Time Frame
    avarage of six mounth
    Title
    Visual Similarity Scale for Fatigue
    Description
    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.
    Time Frame
    avarage of six mounth

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Individuals under the age of 18 Foreign nationals Those with maling disease Pregnant

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment Adherence and Fatigue in Iron Deficiency

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