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IRCT20210314050700N1 IRCT 2021-04-28 Qazvin University of Medical Sciences The effectiveness of mindfulness intervention on improve medication adherence in patients with heart failure The effectiveness of mindfulness intervention on improve medication adherence in patients with heart failure 2021-04-21 anticipated 120 Complete https://irct.ir/trial/55462 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After preparing a list of the patients with heart failure and considering the entry and exit criteria using a table of random numbers and one by one, individuals will be assigned to the experimental group and control group. N/A Condition 1: Mindfulness intervention. Condition 2: Heart failure. Condition 3: Medication adherence. Intervention 1: Intervention group: it is includes 50 individuals of the patients heart failure whom will participate in mindfulness sessions.the eight- week training intervention will include: raising awareness of behavior, identifying the patient's problem, building self-efficacy and commitment in the patient, creating the right plan, evaluating the training program, and finally maintaining behavior change. Introducing mindfulness and its various exercises will also be part of the intervention.It will include eight sessions and The duration of each course will be 40-50 minutes. Intervention 2: Control group: It is includes 50 individuals of the patients heart failure for whom will be performed traditional teachings.In the control group, the questionnaires will be completed again one month and three months later without any intervention. Yes - There is a plan to make this available What will be shared: All of individual' s data then accomplish unrecognizable,is shared When: Start the access period is six months after the results were published To whom: Data will only be available to researchers working in academic and scientific institutions. Conditions: The data are only for the promotion of adherence to treatment. And interfering in the drug composition of patients is not ethical. Where to obtain: Amir Pakpour Haghi Agha and Easa Mohammadizeidi and Zeynep Alimoradi and Zohre Ebadian apakpour@qums.ac.ir zohre.ebadian2020@gmail.com easamohammadizeidi@gma il.com Z.alimoradi@qums.ac.ir How to obtain: By mail: apakpour@qums.ac.ir easamohammadizeidi@gma il.com Z.alimoradi@qums.ac.ir Comments:
public Zohre Ebadian
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 info@qums.ac.ir Qazvin University of Medical Sciences scientific Amir Pakpour HajI Agha
Shahid Bahonar Boulevard
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 Amir.pakpour@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent and voluntary participation in the study Have a heart failure diagnosed by cardiologist No mental disorders or addiction Level of education No more than 70 years old Having digital literacy and familiarity with social networks no limit 70 years Both Reluctance to participate in the study Severe psychological or physical consequences Drug addiction History of attending or participating in a mindfulness training program related to medication adherence Patient who is responsible for the timely use of his drugs Taking drugs that somehow affect the patient's consciousness Lack of literacy I50 Heart failure Behavior Behavior Intervention group: it is includes 50 individuals of the patients heart failure whom will participate in mindfulness sessions.the eight- week training intervention will include: raising awareness of behavior, identifying the patient's problem, building self-efficacy and commitment in the patient, creating the right plan, evaluating the training program, and finally maintaining behavior change. Introducing mindfulness and its various exercises will also be part of the intervention.It will include eight sessions and The duration of each course will be 40-50 minutes. Control group: It is includes 50 individuals of the patients heart failure for whom will be performed traditional teachings.In the control group, the questionnaires will be completed again one month and three months later without any intervention. Assessing the behavior of medication adherence. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Medication Adherence Rating Scale. Self-efficacy. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Health Action Process Approach Questionnaire. Assessing the perceived risk of non-adherence medication. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Health Action Process Approach Questionnaire. Assessing planned behavior. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Health Action Process Approach Questionnaire. Behavioral intention. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Health Action Process Approach Questionnaire. Outcome expectations. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Health Action Process Approach Questionnaire. Quality of life. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Minnesota Living with Heart Failure Questionnaire. Severe insomnia. Timepoint: At the beginning of the study and one month and three months after the educational intervention. Method of measurement: Insomnia severity index Questionnaire. Qazvin University of Medical Sciences Approved 2021-03-13 Ethics committee of Qazvin University of Medical Sciences Deputy of Research and Technology, Qazvin University of Medical Sciences, Movadat Alley, Shahid Beheshti Boulevard Qazvin Qazvin Iran (Islamic Republic of)