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IRCT20230221057476N1 IRCT 2023-06-28 Shahid Beheshti University of Medical Sciences Effectiveness of combined training program in patients with heart failure Investigating the Efficacy of a combined training program on Clinical Outcome of Patients with Heart Failure 2023-06-22 anticipated 136 Complete https://irct.ir/trial/68706 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: it is of random block type into intervention and control groups, the list of blocks was obtained by a statistical consultant. 34 cards are created in random order from 1 to 34, each card contains a combination of 4 in 34 different envelopes. it is transparent. in order to maintain the random sequence the outer surface of the envelopes has been numbered in the same order. in this way after the arrival of each patient according to the block prepared in the previous step the patient is randomly placed in the intervention or control group, Blinding description: the study was blinded and the data analyst was blinded. N/A Heart failure. Intervention 1: Intervention group: For 8 weeks, every week in a group they will receive an educational content related to various aspects of the disease including drug treatment, diet, physical activity, etc on the platform of one of the available mass messengers, but the feedback from the content presented individually will be taken from the patients every week in the same messenger and also questions related to the symptoms experienced related to the disease during the last week will be asked to monitor the health status of the patients so that they can contact the patients if necessary. they should be taken on the phone and their clinical condition will be evaluated so that the patient can be referred to the treatment center if necessary.Patients enter the study at the time of visiting the clinic, and until the next visit, which takes an average of 2 to 3 months, during this time, the researcher does not have face-to-face training. All training communication is done and tracked on a virtual and remote platform. Intervention 2: Control group: during the period of 8 weeks they will not receive any training or follow up either through messengers or through phone calls and they will be visited only if they go to the clinic in person and they will receive the necessary recommendations according to the previous routine at the time of the visit. at the end of the study and after completing the questionnaires all the content taught to the intervention group will be available to the members of the control group as well. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Zohreh Shahbazi
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1996835119 02188655366-70 nrszohreshahbazi@gmail.com Shahid Beheshti University of Medical Sciences scientific Zohreh Shahbazi
Faculty of Nursing, Shahid Beheshti University of Medical sciences
Tehran Iran (Islamic Republic of) 1996835119 02188655366-70 nrszohreshahbazi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having at least 18 years old of age with confirmation of the diagnosis of heart failure Class 1 to 3 heart failure based on NYHA functional classification Access to a smart phone and the internet and the ability to use it Not suffering from other chronic and major disorders such as cancer, depression, mental disability and vision or hearing problems. 18 years no limit Both Facing severe physical problems or death during study Hospitalization of the patient for any reason or change in treatment process I50 Heart failure Lifestyle Lifestyle Intervention group: For 8 weeks, every week in a group they will receive an educational content related to various aspects of the disease including drug treatment, diet, physical activity, etc on the platform of one of the available mass messengers, but the feedback from the content presented individually will be taken from the patients every week in the same messenger and also questions related to the symptoms experienced related to the disease during the last week will be asked to monitor the health status of the patients so that they can contact the patients if necessary. they should be taken on the phone and their clinical condition will be evaluated so that the patient can be referred to the treatment center if necessary.Patients enter the study at the time of visiting the clinic, and until the next visit, which takes an average of 2 to 3 months, during this time, the researcher does not have face-to-face training. All training communication is done and tracked on a virtual and remote platform. Control group: during the period of 8 weeks they will not receive any training or follow up either through messengers or through phone calls and they will be visited only if they go to the clinic in person and they will receive the necessary recommendations according to the previous routine at the time of the visit. at the end of the study and after completing the questionnaires all the content taught to the intervention group will be available to the members of the control group as well. Adherence to treatment. Timepoint: Before the start of the intervention and one month after the end of the intervention. Method of measurement: Morisky Medication Adherence Scale. Self care in patients with heart failure. Timepoint: Before the start of the intervention and one month after the end of the intervention. Method of measurement: European Heart Failure Self-Care Behavior Scale. Shahid Beheshti University of Medical Sciences Approved 2023-06-22 Ethics Committee in Biomedical Research Shahid Beheshti University of Medical Sciences Tehran, Shahid Chahmran Highqway, Yaman St, Arabi St Tehran Tehran Iran (Islamic Republic of)