the effect of counseling based on Roy's adaptation model on fatigue and adherence to treatment in patients with MI.
Design
Controlled random clinical trials with parallel groups with a sample size of 50
Settings and conduct
Consultation sessions will be conducted based on the results of the Roy model evaluation at the heart clinic affiliated to Zanjan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Written consent to participate in the study
Having a history of myocardial infarction for at least three months
Inappropriate fatigue and adherence to inappropriate treatment
Having a acute Myocardial Infarction
Myocardial infarction complications such as heart failure, acute pulmonary edema and ...
Intervention groups
Demographic characteristics, fatigue and adherence to treatment of both groups were evaluated first. Then samples in the intervention group were identified based on ROY compatibility form, maladaptive behaviors, and major, underlying and residual maladaptive behaviors. The care program - counseling including 2-6 sessions of direct and individual intervention was implemented according to the needs of patients for 30-45 minutes at affiliated heart clinic of Zanjan University of Medical Sciences. Telephone follow-up was performed for two months and then post-test. In the control group, in order to control the impact of the presence of medical professional care givers as a confounder variable, during the sessions to complete the questionnaires, general questions of the samples were answered and then, the dependent variables were measured in both groups.
Main outcome variables
The fatigue variable; Adherence variable to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130124012257N9
Registration date:2019-08-30, 1398/06/08
Registration timing:retrospective
Last update:2019-08-30, 1398/06/08
Update count:0
Registration date
2019-08-30, 1398/06/08
Registrant information
Name
Farhad Ramezani-Badr
Name of organization / entity
Zanjan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 24 3527 9412
Email address
ramazanibadr@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-06-20, 1397/03/30
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2019-05-21, 1398/02/31
Scientific title
The effect of counseling based on Roy adaptation model on Multidimensional fatigue and adherence to treatment in patients with myocardial infarction
Public title
The effect of Roy adaptation model on fatigue and adherence to treatment in patients with MI
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having written consent to participate in the study and knowledge of the place and time
ability to communicate and call in the research period
History of myocardial infarction for at least three months
Moderate and severe fatigue, as well as adherence to good to low treatment based on the questionnaires used
Only one doctor is a cardiologist
Exclusion criteria:
There are known psychological disorders
Acute myocardial infarction
Having communication problems such as blindness, deafness and any cognitive impairment
Complications of myocardial infarction, such as heart failure, myocardial rupture, acute pulmonary edema, pericarditis, cardiogenic shock
The presence of any underlying illness that affects dependent variables.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the blocking method will be used. In the blocking technique, blocks are created with a pair size (usually four or six) blocks, in which randomly half the individuals of each block in one group and the other half In the other group. Then the block is chosen so as to reach the required sample size. In this study, to place 50 people in two groups of 25, first all four modes in which half of the subjects are group A and the other half are assigned to group B. These states are written below:
1 b b a a
2 b a b a
3- a b b a
4 a a b b
5- a b a b
6- b a a b
We then assign each of these four combinations one of the digits 1 to 6. In the next step, we need to select 13 random blocks of four blocks and write their combinations in succession. To do this, we need to put 6 samplers in this community 13 times. In this way we will have two groups: 25 in the control group and 25 in the test group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study did not know about belonging to the intervention and control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
First of Jomhore Eslami Blvd, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-05-25, 1397/03/04
Ethics committee reference number
IR.ZUMS.REC.1397.91
Health conditions studied
1
Description of health condition studied
Fatigue
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Adherence to treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue and its dimensions in the studied patients
Timepoint
This variable will be measurement once befor the intervention and again 2 month after the end of intervention.
Method of measurement
Multidimensional fatigue inventory
2
Description
Adherence to treatment
Timepoint
This variable will be measurement once befor the intervention and again 2 month after the end of intervention.
Method of measurement
The scale of adherence to treatment questionnaire of Medical Outcomes Study
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the samples in the intervention group based on the form of exploring and recognizing the pattern of zinc adaptation, incompatible behaviors and the main, underlying and residual impulsive behaviors were identified in each of the four physiological dimensions, self-understanding, role play, autonomy, and dependence . A care program called counseling sessions consisting of 2 to 6 sessions of direct and individual intervention as variables according to patients' needs each time for a period of 45 to 30 minutes by the researcher and other members of the research team at the heart clinic affiliated to the Ayatollah Mousavi Hospital. was planned and implemented. Phone follow up for two months and then post-test.
Category
Behavior
2
Description
Control group: In the control group, in order to control the effect of the professional medical sciences as an interventional variable, during the holding of the sessions to complete the questionnaires, the general questions of the samples, which had no relation to the main intervention of the researcher, were answered. Follow up for two Month and then post-test.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart clinic affiliated to Ayatollah Mousavi Hospital
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Hosseininezhad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 57, Behruz Sharifian Ave., Felestin street, Rasht city
City
Rasht
Province
Guilan
Postal code
4187697461
Phone
+98 13 3382 2166
Email
seyedehmaryam.hsn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farhad Ramezani-Badr
Position
Nursing PhD, associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery , Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515789589
Phone
+98 24 3377 2513
Fax
Email
ramazanibadr@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyyedeh Maryam Hosseininezhad
Position
دانشجو کارشناسی ارشد داخلی - جراحی
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Zanjan University of Medical Sciences, Haj Mahdavi Blv. Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613113
Phone
+98 24 4433 1004
Email
Seyedehmaryam.hsn@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
The data file and report of the study method and results of this study will be published in a peer-reviewed journal.The data file in SPSS software can be presented on request by the relevant journal.
When the data will become available and for how long
2019-2020
To whom data/document is available
Officials, administrators, and supervisors associated with this study at Zanjan University of Medical Sciences have access to the data and documentation of this study while maintaining the confidentiality of the participants and observing ethical considerations.
Under which criteria data/document could be used
The data of this study can be used for decision making by senior managers of Zanjan University of Medical Sciences, while protecting the confidentiality of participants and ethical considerations.
From where data/document is obtainable
Farhad Ramezani Badr- Zanjan University of Medical Sciences
What processes are involved for a request to access data/document
Contact with the author responsible for this study- Farhad Ramezani Badr