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IRCT20210427051097N1 IRCT 2022-06-15 Iran University of Medical Sciences Evaluation of the using HEART Application in Patients with Heart Failure A Study of the Effectiveness of the HEART Application Use on Clinical Outcomes and Quality of LIfe of Patients with Heart Failure 2021-12-22 anticipated 40 Complete https://irct.ir/trial/58463 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After signing an informed consent, patients will be recruited in the study. This study will have two assigned groups (treatment or T, and control or C). A block with the size of 4 patients will be defined, and all possible balanced combinations of assignment within the blocks will be calculated. Then, patients will be assigned to one of the two groups, using a random number table, by a third person (rather than the physician and the researcher), Blinding description: Participants: Each target and control group participant will receive a file for the assigned intervention (application or the PDF booklet). If a patient needs companionship to receive the file, only one companion will be allowed in the room. To sum up, only the interventionist, the patient, and a maximum of one companion will be present in the room. Patients will be assigned visit times with a 30-minute interval to prevent crowding. With each patient being visited at separately assigned visit times, the goal of a minimum chance of patients seeing each other will be achieved. Patients will receive the required explanations to avoid talking to the physician about the assigned intervention, and in case of speaking of it, only refer to it as the "intervention". After receiving the file (target or control), patients will leave the location. Clinical caregiver: The physician will be blinded to the intervention type in all stages of the intervention including visiting and follow-up till the end of the study. The physician will be instructed to avoid speaking about the type of intervention to the patients, and in case of talking about it, refer to it as the ''intervention''. Data analyst: After gathering all data, the data analyst will receive a version of the data with blinded intervention groups and with no personal information. Then, the data analyst reports the results. Interventionist: The interventionist will be aware of the intervention groups and type of the intervention in both groups. Application developer: Designing the application will be done before patient selection and randomization. The developer will be blinded to the intervention groups until the end of the study. All people involved in the study will be banned from sharing information regarding the assigned groups until the end of the study. N/A congestive heart failure. Intervention 1: Intervention group: using HEART APPLICATION . We are trying to encourage patients with heart failure to better control their weight, blood pressure, and diet, improve their compliance to medication, and increase their physical activity level. We hypothesize that this intervention and these lifestyle modifications will prevent disease progression, hospitalization due to decompensated heart failure, and death. This application will be used daily. Every morning, each patient will enter the information regarding their symptoms including leg swelling, dyspnea, night-time sleep quality, etc., along with the other features of the application. After entering the information, the patients will see their performance based on the score they earn by answering the questions. The performance will display with different colors. If the displayed color is red, the patient must refer to the hospital for seeking medical care, or call the third person of the study for guidance. Also, a reminder will be set to remind the patients twice daily, once in the morning and once at night, to take their medications. The aim of the study is to help the patients adhere to the lifestyle modifications, and no new medication or substance is used in the study. We also do not interfere or change the medication regimen of the patients, and they will take their medications as prescribed by their doctor. Intervention 2: Control group: transferring a pdf file containing healthy life style recommendations for congestive heart failure patients, to the smartphone of patients of the control group. To provide a similar file, the patients in the control group will receive an educational file containing 180 short sentences (lifestyle modification tips), and they will be suggested to read one sentence each day, and try to adapt to that. Same as the intervention group, the patients will not receive any medication or substance. Also, no change will be made in the medication regimen of the patients, and they will take their medications as prescribed by their doctor. Yes - There is a plan to make this available What will be shared: All data of this study will be available, publishable and reachable upon request, with respect to patients' privacy and without revealing their names or personal information. When: Access period starts six months after the results are published To whom: Employees of academic institutions and people working in industry Conditions: Only those in charge will have access to the data. Where to obtain: Arefeh Zavari Phone Number: 0098 21 9214341399 Email Address: zavari.hd@gmail.com How to obtain: Introduce yourself and your job position Authentication Submission of a letter from the legal authorities to the responsible person Review the application for a maximum of 6 months Sending requests after a written commitment not to misuse information scientifically and financially Comments:
public Morteza Hassanzadeh
Rasool-E-Akram Hospital, Niyayesh Ave, Sattarkhan Blvd, Tehran
Tehran Iran (Islamic Republic of) 1445613131 0098 21 64351 drmhxim@gmail.com Iran University of Medical Sciences scientific Morteza Hassanzadeh
Rasool-E-Akram Hospital, Niyayesh Ave, Sattarkhan Blvd, Tehran
Tehran Iran (Islamic Republic of) 1445613131 0098 21 64351 drmhxim@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Having Heart Failure According to AHA Criteria Age between 50 to 75 years old At Least 1 Year has Passed from Diagnosis Having Access to a Smartphone and knowledge to Use it 50 years 75 years Both Lack of Access to Smartphone Having Heart Failure with Preserved Ejection Fraction Having Rare Disease such s HIV, Liver Transplantation and ... I50.32 Chronic diastolic (congestive) heart failure Lifestyle Lifestyle Intervention group: using HEART APPLICATION . We are trying to encourage patients with heart failure to better control their weight, blood pressure, and diet, improve their compliance to medication, and increase their physical activity level. We hypothesize that this intervention and these lifestyle modifications will prevent disease progression, hospitalization due to decompensated heart failure, and death. This application will be used daily. Every morning, each patient will enter the information regarding their symptoms including leg swelling, dyspnea, night-time sleep quality, etc., along with the other features of the application. After entering the information, the patients will see their performance based on the score they earn by answering the questions. The performance will display with different colors. If the displayed color is red, the patient must refer to the hospital for seeking medical care, or call the third person of the study for guidance. Also, a reminder will be set to remind the patients twice daily, once in the morning and once at night, to take their medications. The aim of the study is to help the patients adhere to the lifestyle modifications, and no new medication or substance is used in the study. We also do not interfere or change the medication regimen of the patients, and they will take their medications as prescribed by their doctor. Control group: transferring a pdf file containing healthy life style recommendations for congestive heart failure patients, to the smartphone of patients of the control group. To provide a similar file, the patients in the control group will receive an educational file containing 180 short sentences (lifestyle modification tips), and they will be suggested to read one sentence each day, and try to adapt to that. Same as the intervention group, the patients will not receive any medication or substance. Also, no change will be made in the medication regimen of the patients, and they will take their medications as prescribed by their doctor. Score of SF-36 (Short-Form-36) questionnaire. Timepoint: calculating the score of SF-36 questionnaire during a 6 month period. Method of measurement: using SF-36 questionnaire. Score of MLHFQ questionnaire (Minnesota Living with Heart Failure Questionnaire). Timepoint: calculating the score of MLHFQ questionnaire during a 6 month period. Method of measurement: using MLHFQ questionnaire. Score of EHF.ScB-9 questionnaire (European Heart Failure Self-care Behavior Scale-9). Timepoint: calculating the score of EHF.ScB-9 questionnaire during a 6 month period. Method of measurement: using EHF.ScB-9 questionnaire. Iran University of Medical Sciences Approved 2021-02-21 Ethics committee of Iran University of Medical Sciences NO 52, first west 12 metri, second south 16 metri, west chaharbagh Blvd, south Jannat Abad Tehran Tehran Iran (Islamic Republic of)