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IRCT20100725004443N30 IRCT 2022-02-25 Tehran University of Medical Sciences The effect of comprehensive tele-empowerment program on self-care, uncertainty and readmission in patients with heart failure The effect of comprehensive tele-empowerment program on self-care behaviours, uncertainty and readmission in patients with heart failure 2023-02-19 anticipated 96 Complete https://irct.ir/trial/61895 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). By using the free website http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block will be set to 4, for the control group letter A and for the case group, the letter B will be considered, and finally, by approving the Randomization Sequence in the system for 24 blocks, The assignment sequence will be created for the 96 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, a Shuffling Envelope will be taken by the researcher accidentally. Finally, the random allocation method will be determined by the research samples. N/A Patients with heart failure. Intervention 1: Control group: These patients do not receive any intervention from the researcher, and after the initial visit by the physician, patients will be provided with routine care in heart failure. Intervention 2: Intervention group: Patients in the intervention group will receive 10 weeks of intervention, including 6 weeks of comprehensive tele-empowerment program and 4 weeks of follow-up. Initially, patients will join virtual groups of 10 to 15 people, and the empowerment program will be done comprehensively and according to the physical, psychological and spiritual needs of patients; through the Internet and on the electronic massaging platform. Each week, a specific topic will be addressed to promote patients' self-care. Topics will include familiarity with heart failure and clinical manifestations monitoring, diet modification, physical activity improvement, drug management, stress management and relaxation techniques, spiritual self-awareness and religious coping strategies. The content of each session will be available to all patients equally for 6 weeks as a combination of online and offline sessions (3 online sessions and 3 offline sessions).In offline sessions, an e-booklet and/or an instructional video will be sent to virtual groups, and in online sessions, a Skyroom link will be placed in the virtual group to hold online group sessions. Online group meetings with members of groups of 10 to 15 people formed on the social network will be held for 45 to 60 minutes via the Skyroom platform. This empowerment program will include 5 steps entitled 1) Needs Assessment 2) Goal Setting 3) Structured Education 4) Self-Care Plan Development 5) Evaluation which all steps will be repeated by the researcher and through the electronic messaging program for all the mentioned sessions for each week. Finally, over the next four weeks, patients will be followed up by a 10-minute phone call and their questions will be answered. Yes - There is a plan to make this available What will be shared: The collected deidentified IPD including demographic information, medical history, study outcomes, and other relevant variables When: Data will be available 6 months after publication of the study results up to a period of 5 years after the end of the study. To whom: The deidentified IPD and supporting information will be made available to qualified researchers upon reasonable request. Conditions: Access to the data will be granted to qualified researchers and for research purposes only. Researchers must be affiliated with an academic or research institution and provide the approved proposal and evidence of their qualifications, such as a curriculum vitae or publication record. Requests will be reviewed by the corresponding author to ensure that they are consistent with the study's original aims and objectives. Where to obtain: To obtain the deidentified IPD, interested researchers should submit a request to the corresponding author by email. How to obtain: To request access to the deidentified IPD, interested researchers should submit a request to the corresponding author including a detailed research plan that outlines the research question(s) being addressed, the specific data being requested, and the analytic methods to be used. Researchers should also provide the approved proposal and also evidence of their qualifications and data protection plans. Requests will be reviewed by the corresponding author to ensure that they are consistent with the study's original aims and objectives. Upon receipt of a request, the corresponding author will review the request and respond within 10 business days. Comments:
public Ali Khanipour-Kencha
Nursing and Midwifery School of Tehran University, Easte Nosrat St., Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 ali.khanipour76@gmail.com Tehran University of Medical Sciences scientific Dr Masoumeh Zakerimoghadam
Nursing and Midwifery School of Tehran University, Easte Nosrat St., Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 mzakerimo@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Medical diagnosis of class II or III heart failure (according to the New York Heart Association [NYHA] classification) based on the patient's medical record Medical diagnosis of heart failure for at least 3 months Ability to read and write Persian language Access and ability to use smart phones and the Internet Willingness to participate and complete intervention sessions, social media group interactions, and data collection measures 18 years 65 years Both Diagnosed mental and cognitive disorders documented in the medical record Having vision, hearing, or speaking deficits Participation in or experience of joining similar empowerment programs Heart failure exacerbation reporting experience of severe psychological distress during the study period. I50 Heart failure Behavior Behavior Control group: These patients do not receive any intervention from the researcher, and after the initial visit by the physician, patients will be provided with routine care in heart failure. Intervention group: Patients in the intervention group will receive 10 weeks of intervention, including 6 weeks of comprehensive tele-empowerment program and 4 weeks of follow-up. Initially, patients will join virtual groups of 10 to 15 people, and the empowerment program will be done comprehensively and according to the physical, psychological and spiritual needs of patients; through the Internet and on the electronic massaging platform. Each week, a specific topic will be addressed to promote patients' self-care. Topics will include familiarity with heart failure and clinical manifestations monitoring, diet modification, physical activity improvement, drug management, stress management and relaxation techniques, spiritual self-awareness and religious coping strategies. The content of each session will be available to all patients equally for 6 weeks as a combination of online and offline sessions (3 online sessions and 3 offline sessions).In offline sessions, an e-booklet and/or an instructional video will be sent to virtual groups, and in online sessions, a Skyroom link will be placed in the virtual group to hold online group sessions. Online group meetings with members of groups of 10 to 15 people formed on the social network will be held for 45 to 60 minutes via the Skyroom platform. This empowerment program will include 5 steps entitled 1) Needs Assessment 2) Goal Setting 3) Structured Education 4) Self-Care Plan Development 5) Evaluation which all steps will be repeated by the researcher and through the electronic messaging program for all the mentioned sessions for each week. Finally, over the next four weeks, patients will be followed up by a 10-minute phone call and their questions will be answered. Self-care behaviors. Timepoint: Before the intervention, immediately after ending the intervention. Method of measurement: Nine-Item European Heart Failure Self-Care Behavior Scale (EHFScBS-9). Uncertainty. Timepoint: Before the intervention, immediately after ending the intervention. Method of measurement: Mishel Uncertainty in Illness Scale - Community form (MUIS-C). Number and duration of emergency hospital readmission of patients. Timepoint: Immediately after ending the intervention. Method of measurement: Self-Report of Patients. Tehran University of Medical Sciences Approved 2022-02-09 Research Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Scien Room 604, Sixth Floor, Office building of Tehran University of medical Sciences, Intersection of Ghods St., Keshavarz Blvd., Tehran. Tehran Tehran Iran (Islamic Republic of)