Applied objective: can be by combining such training programs with encouraging patients, including providing information about the medication regimen, to take steps to improve adherence to the medication regimen.it will save on medical costs and, as a result, the occupancy rate of hospital beds, especially in cardiac units, reduce mortality and reduce individual and social treatment costs and reduce the course progression of the disease and delaying their complications.
Specific Objectives:
Determining and comparing the patient of self-efficacy andplaning for the patients about treatment adherence behavior between control and experimental groups before and after the intervention
Design
Clinical trial with control and experimental groups; simple randomization will be performed on 100 patients. G-Power soft ware is used for randomization.
Settings and conduct
Firoozgar and Tehran Heart Center Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: signing informed consent and voluntary participation; suffering from heart failure; no mental disorders or addiction, the power of reading and writing, age not older than 70 years old.
Exit criterion: A patient who is not responsible for taking his medication on time.
Intervention groups
Intervention group: it is includes 50 individuals of the patients heart failure whom will participate in mindfulness sessionsinclude eight sessions and The duration of each course will be 40-50 minutes. its content will include: raising awareness of behavior, identifying the patient's problem, building self-efficacy and commitment in the patient, creating the right plan, evaluating the training program, and finally maintaining behavior change. In the control group, the questionnaires will be completed again one month and three months later without any intervention.
Main outcome variables
Assessing the behavior of medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210314050700N1
Registration date:2021-04-28, 1400/02/08
Registration timing:prospective
Last update:2021-04-28, 1400/02/08
Update count:0
Registration date
2021-04-28, 1400/02/08
Registrant information
Name
Zohre Ebadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5572 0721
Email address
zohre.ebadian2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
2021-05-23, 1400/03/02
Actual recruitment end date
2021-06-23, 1400/04/02
Trial completion date
2021-11-22, 1400/09/01
Scientific title
The effectiveness of mindfulness intervention on improve medication adherence in patients with heart failure
Public title
The effectiveness of mindfulness intervention on improve medication adherence in patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent and voluntary participation in the study
Have a heart failure diagnosed by cardiologist
No mental disorders or addiction
Level of education
No more than 70 years old
Having digital literacy and familiarity with social networks
Exclusion criteria:
Reluctance to participate in the study
Severe psychological or physical consequences
Drug addiction
History of attending or participating in a mindfulness training program related to medication adherence
Patient who is responsible for the timely use of his drugs
Taking drugs that somehow affect the patient's consciousness
Lack of literacy
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
After preparing a list of the patients with heart failure and considering the entry and exit criteria using a table of random numbers and one by one, individuals will be assigned to the experimental group and control group.
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 Qazvin University of Medical Sciences
Street address
Deputy of Research and Technology, Qazvin University of Medical Sciences, Movadat Alley, Shahid Beheshti Boulevard
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.QUMS.REC.1399.558
Health conditions studied
1
Description of health condition studied
Mindfulness intervention
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
3
Description of health condition studied
Medication adherence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Assessing the behavior of medication adherence
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Medication Adherence Rating Scale
2
Description
Self-efficacy
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Health Action Process Approach Questionnaire
3
Description
Assessing the perceived risk of non-adherence medication
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Health Action Process Approach Questionnaire
4
Description
Assessing planned behavior
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Health Action Process Approach Questionnaire
5
Description
Behavioral intention
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Health Action Process Approach Questionnaire
Secondary outcomes
1
Description
Outcome expectations
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Health Action Process Approach Questionnaire
2
Description
Quality of life
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Minnesota Living with Heart Failure Questionnaire
3
Description
Severe insomnia
Timepoint
At the beginning of the study and one month and three months after the educational intervention
Method of measurement
Insomnia severity index Questionnaire
Intervention groups
1
Description
Intervention group: it is includes 50 individuals of the patients heart failure whom will participate in mindfulness sessions.the eight- week training intervention will include: raising awareness of behavior, identifying the patient's problem, building self-efficacy and commitment in the patient, creating the right plan, evaluating the training program, and finally maintaining behavior change. Introducing mindfulness and its various exercises will also be part of the intervention.It will include eight sessions and The duration of each course will be 40-50 minutes.
Category
Behavior
2
Description
Control group: It is includes 50 individuals of the patients heart failure for whom will be performed traditional teachings.In the control group, the questionnaires will be completed again one month and three months later without any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Zohre Ebadian
Street address
Beh Afarin Street, Karim Khan Zand Street, Vali Asr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1000
Fax
+98 21 8894 2622
Email
h-firoozgar@yahoo.com
2
Recruitment center
Name of recruitment center
Tehran Heart Hospital
Full name of responsible person
Zohre Ebadian
Street address
Corner of Jalal-e-Al-e-Ahamad Highway Street,Noth Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
email@thc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Peyman Namdar
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Zohre Ebadian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3333 5162
Email
info@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour HajI Agha
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
Amir.pakpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour Haji Agha
Position
University profession
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
Email
Amir.pakpour@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of individual' s data then accomplish unrecognizable,is shared
When the data will become available and for how long
Start the access period is six months after the results were published
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data are only for the promotion of adherence to treatment. And interfering in the drug composition of patients is not ethical.
From where data/document is obtainable
Amir Pakpour Haghi Agha and Easa Mohammadizeidi and Zeynep Alimoradi and Zohre Ebadian apakpour@qums.ac.ir zohre.ebadian2020@gmail.com
easamohammadizeidi@gma il.com Z.alimoradi@qums.ac.ir
What processes are involved for a request to access data/document
By mail: apakpour@qums.ac.ir
easamohammadizeidi@gma il.com Z.alimoradi@qums.ac.ir