Determination the Effect of follow up care model on self-management in Patients With chronic Heart Failure disease
Design
Randomized control Trial for 90 participants divided into two groups study and control by Block Random Assignment
Settings and conduct
AL-Imam AL-Hussain Medical City in Karbala Iraq was the setting of the current study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who were diagnosed with heart failure since 6 month and more
2. Patients who were accepted to attended in study
3. patients who were conscious
4. patients with stage three and four heart failure.
Exclusion criteria:
1. patients who were reluctant to attended in the study.
2. patients without mental disorders
Intervention groups
Control group: The patients in the control group received the usual care at Al-Imam Al-Hussain Medical City
Study group: The patients in the study group received an educational booklet based on heart failure self-management. The intervention consisted of providing two training sessions, each of which was scheduled to last one hour. Patients in the study group were contacted by phone and sent weekly messages for a period of three months for the purpose of following up with them. Twelve contacts were established with each patient over the course of three months. Additionally, each patient received 24 messages over the course of 12 weeks, divided between two messages per week. Finally, the success of the intervention was evaluated by using SCHFI questionnaire for measuring and comparing self-management. One, two and three months after the intervention, a questionnaire were completed for both groups.
Main outcome variables
Self-maintenance; self-care management; self-care confidence; symptoms perception; number or re-hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230829059300N1
Registration date:2023-09-18, 1402/06/27
Registration timing:retrospective
Last update:2023-09-18, 1402/06/27
Update count:0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Mohammed Khanjary
Name of organization / entity
Alameed University
Country
Iraq
Phone
+964 771 948 5553
Email address
ac_milan515@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
2022-12-01, 1401/09/10
Actual recruitment end date
2023-05-05, 1402/02/15
Trial completion date
2023-05-05, 1402/02/15
Scientific title
Effect of implementation of follow-up care model on self-management in patient with chronic heart failure disease
Public title
Effect of of follow-up care on self management for heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who were diagnosed with heart failure since 6 month and more
Patients who were accepted to attended in study
Patients who were conscious
Patients with stage three and four heart failure.
Exclusion criteria:
Patients who were reluctant to attended in the study.
Patients without mental disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size, the patients were assigned into blocks each block containing the same number of participants. Blocks were then randomly chosen to determine the patients’ assignment into the control and study groups.
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 ethical committees of school of nursing and midwifery and rehabilitation - TUMS
Street address
Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.TUMS.FNM.REC.1401.090
Health conditions studied
1
Description of health condition studied
Heart failure ( can be attributed to various cardiovascular diseases, however, it consistently leads to the same cardiac irregularities, regardless of whether they affect the heart's contractile capacity (systole), filling capacity (diastole), or both.
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
self-management: is the control and responsibility that an individual takes on for the management of their conditions and behaviors
Timepoint
before the intervention and one, two three month after the intervention
Method of measurement
the self management measured by the selfcare of heart failure index version 7.2 scale
Secondary outcomes
1
Description
number of re-hospitalizations in last three months for the heart failure patients
Timepoint
before the intervention and after three month
Method of measurement
the demographic questionnaire
Intervention groups
1
Description
Intervention group: The patients in the intervention group received an educational booklet based on heart failure self-management. The intervention consisted of providing two training sessions, each of which was scheduled to last one hour and take place at a training facility located within Al-Imam AL-Hussain Medical City in Karbala. Sessions cover topics such as understanding the disease's progression, the importance of medication and getting to know the drugs, the best way to take them, and any potential side effects, as well as managing the disease through changes in diet, fluid intake, daily weight, exercise, and symptom management. Patients in the research group were contacted by phone and sent weekly messages for a period of three months for the purpose of following up with them. The number of contacts that were made with the patient was sufficient to allow for the establishment of weekly communication with each patient. The duration of each patient's phone call varied based on their individual circumstances and the number of questions they had about their condition. Twelve contacts were established with each patient over the course of three months. Additionally, each patient received 24 messages over the course of 12 weeks, divided between two messages per week. Patients and their fellows were provided a written outline of the training sessions' contact schedule during the study. Finally, the success of the intervention was evaluated by using the SCHFI questionnaire for measuring and comparing self-management. One, two, and three months after the intervention, a questionnaire was completed for both groups.
Category
Other
2
Description
Control group: The patients in the control group received the usual care at Al-Imam Al-Hussain Medical City but at the end of the intervention, they had access to the educational material.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Imam AL-Hussain medical city
Full name of responsible person
Taqwa Khudair Abdel Karim
Street address
al-shuhdaa st.
City
Karbala
Postal code
56001
Phone
+964 781 195 5595
Email
soudadalzabidey@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Lali Syadai
Street address
Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 933 199 9322
Email
ursing_intl@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
Alireza Nikbakht Nasrabadi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 912 205 5362
Email
nikbakht@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoh Varaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 912 218 6498
Email
shvaraei@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoh Varaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 912 218 6498
Email
shvaraei@sina.tums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
in IPD the Demographic information including age, gender, marital status, level of education, stage of heart failure, duration of heart disease, side of heart failure, number of hospitalizations during the last three months, and occupation Status will be shared.
When the data will become available and for how long
when the research is published and won't be removed
To whom data/document is available
researcher and the health care provider
Under which criteria data/document could be used
the data will be available for all researchers and the health care provider without any criteria
From where data/document is obtainable
contact with this Email: ac_milan515@yahoo.com
What processes are involved for a request to access data/document
data will sent to the applicant after receiving his request