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The effect of an Educational Intervention Based on PRECEDE – PROCEED Model on treatment adherence and readmition rate among Patients with heart failure

Protocol summary

Study aim
Determining the effect of educational intervention based on PRECEDE-PROCEED model on treatment adherence and readmission rate in heart failure patients
Design
A controlled clinical trial with parallel groups,without blinding,72 pationts,randomized,randomization by www.randomization.com
Settings and conduct
The research setting is a cardiac clinic in Dehdasht associated with Yasouj University of Medical Sciences.72 patients are selected according to the inclusion criteria and after randomisation,36 people are placed in the intervention group and receive educational intervention; The control group receives routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Patients with heart failure, age over 50 years, history of hospitalization at least once, heart failure of one year and more; Exclusion criteria; Having a psychological illness, Chronic diseases other than hypertension and diabetes
Intervention groups
Intervention group: The educational intervention is designed based on the third phase of the Precede- Proceed Model, educational assessment, among the predisposing, enabling, and reinforcing constructs. Before and after the intervention, a demographic questionnaire, the Madanloo treatment adherence questionnaire, and a researcher-made readmission inventory will be completed. Post-test will be conducted one and three months after training, respectively. The intervention is performed for the experimental group in a month (two sessions per week).Researchers will use PowerPoint slides and educational posters in all sessions. During this time, the intervention group will join a virtual educational channel, and the educational materials will be shared in this channel.Spouse or key person of a meeting Will receive training. control group;The control group will only receive their usual care.
Main outcome variables
treatment Adherence,Readmission

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200922048806N1
Registration date: 2021-03-30, 1400/01/10
Registration timing: registered_while_recruiting

Last update: 2021-03-30, 1400/01/10
Update count: 0
Registration date
2021-03-30, 1400/01/10
Registrant information
Name
Fereshte Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 5907
Email address
8238fereshte.eskandari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an Educational Intervention Based on PRECEDE – PROCEED Model on treatment adherence and readmition rate among Patients with heart failure
Public title
The effect of an Education on treatment adherence and readmition in Patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
History of hospitalization at least once Have at least one year of heart failure Have Class II (mild) and III (moderate) heart failure based on the New York Heart Association classification scale and specialist physician approval Age over 50 years Minimum literacy Living with family The ability to use smartphones
Exclusion criteria:
Having psychological illnesses Chronic diseases other than hypertension and diabetes
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 72 samples are selected based on the inclusion criteria and by convenience sampling method, and are allocated to the control and intervention groups using block random allocation method.. Depending on the sample size, 18 blocks of 4 are required for random block allocation. The intervention group will be displayed with A and the control group with B. Samples can be placed in blocks in 6 different modes. The website https://www.Randomization.com will be used to determine the random sequence of blocks. In order to allocation concealment from the researcher, 72 dark envelopes were prepared and each of the random sequences created was recorded on a card and placed inside the envelope, and finally the envelope lid was pasted. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified.
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 the School of Nursing and Midwifery and the School of Rehabilitation, Tehran Uni
Street address
Tehran University of Medical Sciences., ghods Ave., Keshavarz BLvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.TUMS.FNM.REC.1399.096

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Score of treatment adherence in madanloo questionnaire
Timepoint
Before study, One month after study and Three month after study
Method of measurement
Madanloo treatment adherence questionnaire

2

Description
Percentage of people with readmission
Timepoint
One month after study and Three month after study
Method of measurement
Researcher-made questionnaire on readmission rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The educational intervention is designed based on the third phase of the Precede- Proceed Model, educational assessment, among the predisposing, enabling, and reinforcing constructs. Then, impact evaluation is carried out to examine the immediate effect of the program, including therapy adherence and readmission. Predisposing factors include the knowledge, attitudes, and beliefs of the affected person. Two 60-minute face-to-face sessions will be held to promote patients' awareness. In the first training session, we will discuss the following themes: familiarity of patients with adherence to treatment and medication, their knowledge about the benefits of treatment adherence and how to use medication, the definition of adherence to medication and therapy, and factors affecting these variables, appropriate dietary and lifestyle changes in heart failure according to the existing recommendations, and approaches to control these variables. There will be two 60-minute discussion sessions to assess patients' attitudes and provide the researcher's opinion to the participants. Reinforcing factors in this study include encouragement from the spouse or a family member (a key figure in a person's life). A 60-minute face-to-face meeting will be held with the key person to discuss the family's role in the disease process, encouragement strategies, and methods to motivate the patient. The enabling factors include two 60-minute training sessions to discuss the role of mass media in treatment adherence and the importance of quality of life improvement. Also, the authors will use a virtual social network. Finally, there will be a session to review the issues and resolve the problems and any ambiguities. Researchers will use PowerPoint slides and educational posters in all sessions. The intervention is performed for the experimental group in a month (two sessions per week). During this time, the intervention group will join a virtual educational channel, and the educational materials will be shared in this channel. Before and after the intervention, a demographic questionnaire, the Madanloo treatment adherence questionnaire, and a researcher-made readmission inventory will be completed. Post-test will be conducted one and three months after training, respectively.
Category
Lifestyle

2

Description
Control group: The control group will not receive any intervention and receive routine care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac clinic in Dehdasht associated with Yasouj University of Medical Sciences
Full name of responsible person
Ali akbar Akbarpoor
Street address
Emam Khomeini Hospital., Sepah Ave., Parastar Blvd., Dehdasht, Yasouj
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571888655
Phone
+98 74 3226 5907
Fax
+98 74 3226 8400
Email
Akbarppor.Arshad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeyan
Street address
Tehran University of Medical Sciences., ghods Ave., Keshavarz BLvd., Tehran
City
Theran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Fax
Email
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
Fereshte Eskandari
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam khomaini Hospital., Sepah ave., Parastar Blvd., Dehdasht., Yasouj
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571888655
Phone
+98 74 3226 5904
Email
8238fereshte.eskandari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Pashahipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences., Nosrat st., Tohid sq., TEHRAN., IRAN
City
Theran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4142
Email
sh-pashaeipour@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fereshte Eskandari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam khomaini Hospital., Sepah Ave., Prastar Blvd., Dehdasht., Yasouj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
۸۵۴۳۲۹۷۶۵۰
Phone
+98 912 006 5499
Email
8238fereshte.eskandari@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
No - There is not 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
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