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General information
2023-06-20, 1402/03/30
2023-07-30, 1402/05/08
2023-0607-2030 00:00:00
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
Experience of severe psychological distress during the study
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.
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 Experiencereporting experience of severe psychological distress during the study period.
اختلالات روانی و شناختی تشخیص داده شده در پرونده پزشکی
داشتن اختلال بینایی، شنوایی یا گفتاری
مشارکت یا تجربه پیوستن به برنامه های توانمندسازی مشابه
تشدید بیماری نارسایی قلبی
ایجاد استرس روانی شدید حین انجام مطالعه
اختلالات روانی و شناختی تشخیص داده شده در پرونده پزشکی
داشتن اختلال بینایی، شنوایی یا گفتاری
مشارکت یا تجربه پیوستن به برنامه های توانمندسازی مشابه
تشدید بیماری نارسایی قلبی
گزارش کردن تجربه ی استرس روانی شدید در حین انجام مطالعه
اختلالات روانی و شناختی تشخیص داده شده در پرونده پزشکی داشتن اختلال بینایی، شنوایی یا گفتاری مشارکت یا تجربه پیوستن به برنامه های توانمندسازی مشابه تشدید بیماری نارسایی قلبی ایجادگزارش کردن تجربه ی استرس روانی شدید در حین انجام مطالعه
Sharing plan
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
no
undecidedno
undecided
no
undecidedno
undecided
no
undecidedno
undecided
no
undecidedno
undecided
no
undecidedno
There is no further information
empty
There is no further information
اطلاعات بیشتری وجود ندارد
empty
اطلاعات بیشتری وجود ندارد
empty
The collected deidentified IPD including demographic information, medical history, study outcomes, and other relevant variables
The collected deidentified IPD including demographic information, medical history, study outcomes, and other relevant variables
empty
داده های جمع آوری شده شامل اطلاعات دموگرافیک، سابقه پزشکی، پیامدهای مطالعه و سایر متغیرهای مرتبط پس از غیر قابل شناسایی کردن افراد
داده های جمع آوری شده شامل اطلاعات دموگرافیک، سابقه پزشکی، پیامدهای مطالعه و سایر متغیرهای مرتبط پس از غیر قابل شناسایی کردن افراد
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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.
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.
empty
داده ها از 6 ماه پس از انتشار نتایج مطالعه تا یک دوره 5 ساله پس از پایان مطالعه در دسترس خواهند بود.
داده ها از 6 ماه پس از انتشار نتایج مطالعه تا یک دوره 5 ساله پس از پایان مطالعه در دسترس خواهند بود.
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The deidentified IPD and supporting information will be made available to qualified researchers upon reasonable request.
The deidentified IPD and supporting information will be made available to qualified researchers upon reasonable request.
empty
داده های غیر قابل شناسایی افراد و اطلاعات پشتیبان در صورت درخواست معقول در اختیار پژوهشگران واجد شرایط قرار خواهد گرفت.
داده های غیر قابل شناسایی افراد و اطلاعات پشتیبان در صورت درخواست معقول در اختیار پژوهشگران واجد شرایط قرار خواهد گرفت.
empty
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.
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.
empty
دسترسی به داده ها به پژوهشگران واجد شرایط و فقط برای اهداف پژوهشی اعطا خواهد شد. پژوهشگران باید وابسته به یک مؤسسه دانشگاهی یا تحقیقاتی باشند و پروپوزال تأیید شده و مدارک مبنی بر صلاحیت خود، مانند رزومه تحصیلی یا سابقه انتشار مقاله را ارائه دهند. درخواستها توسط نویسنده مسئول بررسی میشود تا اطمینان حاصل شود که با اهداف اصلی و فرعی مطالعه مطابقت دارند.
دسترسی به داده ها به پژوهشگران واجد شرایط و فقط برای اهداف پژوهشی اعطا خواهد شد. پژوهشگران باید وابسته به یک مؤسسه دانشگاهی یا تحقیقاتی باشند و پروپوزال تأیید شده و مدارک مبنی بر صلاحیت خود، مانند رزومه تحصیلی یا سابقه انتشار مقاله را ارائه دهند. درخواستها توسط نویسنده مسئول بررسی میشود تا اطمینان حاصل شود که با اهداف اصلی و فرعی مطالعه مطابقت دارند.
empty
To obtain the deidentified IPD, interested researchers should submit a request to the corresponding author by email.
To obtain the deidentified IPD, interested researchers should submit a request to the corresponding author by email.
empty
برای دسترسی به داده های غیر قابل شناسایی افراد، محققان علاقه مند باید درخواست خود را از طریق ایمیل به نویسنده مسئول ارسال کنند.
برای دسترسی به داده های غیر قابل شناسایی افراد، محققان علاقه مند باید درخواست خود را از طریق ایمیل به نویسنده مسئول ارسال کنند.
empty
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.
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.
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برای درخواست دسترسی به داده های غیر قابل شناسایی افراد،، محققان علاقهمند باید درخواستی را به نویسنده مسئول ارسال کنند که شامل یک طرح تحقیق مفصل است که در آن سؤال(های) تحقیق مورد بررسی، دادههای خاص درخواست شده و روشهای تحلیلی مورد استفاده توضیح داده شود. محققان همچنین باید پروپوزال تایید شده و همچنین مدارکی مبنی بر صلاحیت خود و برنامه خود برای حفاظت از داده ها ارائه دهند.
درخواستها توسط نویسنده مسئول بررسی میشود تا اطمینان حاصل شود که با اهداف و اهداف اصلی مطالعه مطابقت دارند. پس از دریافت درخواست، نویسنده مربوطه درخواست را بررسی کرده و ظرف 10 روز کاری پاسخ خواهد داد.
برای درخواست دسترسی به داده های غیر قابل شناسایی افراد،، محققان علاقهمند باید درخواستی را به نویسنده مسئول ارسال کنند که شامل یک طرح تحقیق مفصل است که در آن سؤال(های) تحقیق مورد بررسی، دادههای خاص درخواست شده و روشهای تحلیلی مورد استفاده توضیح داده شود. محققان همچنین باید پروپوزال تایید شده و همچنین مدارکی مبنی بر صلاحیت خود و برنامه خود برای حفاظت از داده ها ارائه دهند. درخواستها توسط نویسنده مسئول بررسی میشود تا اطمینان حاصل شود که با اهداف و اهداف اصلی مطالعه مطابقت دارند. پس از دریافت درخواست، نویسنده مربوطه درخواست را بررسی کرده و ظرف 10 روز کاری پاسخ خواهد داد.
Protocol summary
Study aim
Determining the effect of comprehensive tele-empowerment program on self-care behaviors, uncertainty and readmission of heart failure patients
Design
Randomized clinical trial; with control group, parallel groups, without blindness
Settings and conduct
Selecting 96 patients with heart failure referred to Imam Khomeini Hospital in Tehran and dividing them into two groups of control and intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of class II or III heart failure according to the New York Heart Association classification; Diagnosis of heart failure for at least 3 months; Ability to read and write; Access and ability to use smartphones and the Internet; Willingness to participate and complete intervention. Exclusion criteria: Mental and cognitive disorders; Having vision, hearing or speaking deficits; Participation in similar programs; Heart failure exacerbation; Experience of severe psychological distress.
Intervention groups
The control group receives usual care. the intervention group will receive 10 weeks of intervention including 6 weeks of comprehensive tele-empowerment program and 4 weeks of follow-up. Empowerment program will be implemented weekly through the Internet (online and offline) with the following topics: Familiarity with heart failure, clinical manifestations monitoring, diet modification, physical activity improvement, drug management, stress management, spiritual self-awareness and offering religious coping strategies. Simultaneously, patients will join virtual groups on the electronic messaging app and 5 stages of the empowerment program, including 1) needs assessment 2) goal setting 3) structured education 4) self-care plan development 5) evaluation will be repeated each week. Finally, patients will be followed up by telephone and their questions will be answered.
Main outcome variables
Self-care behaviors and uncertainty
General information
Reason for update
The sampling time was updated.
Because of more cooperation, the recruitment center was changed to Imam Khomeini Hospital in Tehran.
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N30
Registration date:2022-02-25, 1400/12/06
Registration timing:prospective
Last update:2023-07-13, 1402/04/22
Update count:3
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-07-30, 1402/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of comprehensive tele-empowerment program on self-care behaviours, uncertainty and readmission in patients with heart failure
Public title
The effect of comprehensive tele-empowerment program on self-care, uncertainty and readmission in patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Scien
Street address
Room 604, Sixth Floor, Office building of Tehran University of medical Sciences, Intersection of Ghods St., Keshavarz Blvd., Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.TUMS.FNM.REC.1400.194
Health conditions studied
1
Description of health condition studied
Patients with heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
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)
2
Description
uncertainty
Timepoint
Before the intervention, immediately after ending the intervention
Method of measurement
Mishel Uncertainty in Illness Scale - Community form (MUIS-C)
Secondary outcomes
1
Description
Number and duration of emergency hospital readmission of patients
Timepoint
Immediately after ending the intervention
Method of measurement
Self-Report of Patients
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Keshavarz Blvd., Ghods St., Central Organization of the University, 6th floor of Research and Technology Department
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
Email
vcr@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Khanipour-Kencha
Position
Master Student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Tehran University, Easte Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
ali.khanipour76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Zakerimoghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Tehran University, Easte Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
mzakerimo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Khanipour-Kencha
Position
Master Student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Tehran University, Easte Nosrat St., Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
Email
ali.khanipour76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The collected deidentified IPD including demographic information, medical history, study outcomes, and other relevant variables
When the data will become available and for how long
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 data/document is available
The deidentified IPD and supporting information will be made available to qualified researchers upon reasonable request.
Under which criteria data/document could be used
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.
From where data/document is obtainable
To obtain the deidentified IPD, interested researchers should submit a request to the corresponding author by email.
What processes are involved for a request to access data/document
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.