Determining the effect of comprehensive tele-empowerment program on self-care behaviors, uncertainty and readmission of patients with heart failure
Design
Randomized clinical trial; with control group, parallel groups, without blindness
Settings and conduct
Selection of 96 patients with heart failure referred to Tehran Heart Center 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; Being in a stable state of the disease; Ability to read and write; Absence of diagnosed mental and cognitive disorders; Access and ability to use smart phones. Exclusion criteria: Death or withdrawal; Lack of cooperation during the research; Entry into the acute phase of the disease; Development of severe psychological stress.
Intervention groups
The control group receives routine clinic care and medication instructions. 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 WhatsApp groups and 5 stages of the empowerment program, including 1) needs assessment 2) structured education 3) goal setting 4) self-care plan development 5) evaluation will be repeated for 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
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N30
Registration date:2022-02-25, 1400/12/06
Registration timing:prospective
Last update:2022-02-25, 1400/12/06
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
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-20, 1401/03/30
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
Being in a stable state of the disease
Ability to read and write Persian language
Ability to communicate
Absence of diagnosed mental and cognitive disorders
Not participating in similar empowerment programs
Access and ability to use smart phones and the Internet
Exclusion criteria:
Death or withdrawal of participants from the study
Lack of cooperation during the research (non-participation in more than one online empowerment session or non-participation in the WhatsApp group)
Patient entry into the acute phase of the disease
Development of severe psychological stress during the study
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
Ethics committee of Tehran University of Medical Sciences
Street address
Office building of Tehran University of medical Sciences, Keshavarz St, 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 WhatsApp 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 WhatsApp 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 WhatsApp groups, and in online sessions, a Skyroom link will be placed in the WhatsApp 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) Structured Education 3) Goal Setting 4) Self-Care Plan Development 5) Evaluation which all steps will be repeated by the researcher and through WhatsApp 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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Tehran Heart Center, corner of Jalal Al-Ahmad Highway, North Kargar-Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
thc@tums.ac.ir
Web page address
http://thc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
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)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available