Protocol summary

Study aim
The effect of Need-Based Education on Clinical Outcomes in Patients under treatment with Direct oral anticoagulants (DOACs) drugs in Hospital Affiliated to Shiraz University of Medical Sciences
Design
Clinical trial with control group, with parallel groups, unblinded, randomized, on 92 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
By referring to Namazi and Shahid Fagihi hospitals, two intervention and control groups are randomly selected from among the referring patients who meet the conditions for entering the study, and blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being between 18 and 80 years old; Receiving oral anticoagulants; The client's ability to learn the instructions and perform the self-care process. Exclusion criteria: Presence of active bleeding; The presence of mental illnesses and the use of psychotropic drugs according to the patient's statement.
Intervention groups
Intervention group: For the educational group, need-based training in the form of educational pamphlets and face-to-face training will be conducted on the day of the interview, the second and fourth week, in person and by phone. Control group: will only receive the usual training and care.
Main outcome variables
Medication adherence, The international normalized ratio (INR)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231204060260N1
Registration date: 2024-01-24, 1402/11/04
Registration timing: registered_while_recruiting

Last update: 2024-01-24, 1402/11/04
Update count: 0
Registration date
2024-01-24, 1402/11/04
Registrant information
Name
Fariba Bakhshayesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8355 4810
Email address
faribabakhshayesh815@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Need-Based Education on Clinical Outcomes in Patients under treatment with Direct oral anticoagulants (DOACs) drugs in Hospital Affiliated to Shiraz University of Medical Sciences
Public title
Effect of Need-Based Education on Clinical Outcomes in Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 80 years old Receiving oral anticoagulants The client's ability to learn the instructions and perform the self-care process
Exclusion criteria:
Presence of active bleeding The presence of mental illnesses and the use of psychotropic drugs according to the patient's statement
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be convenience; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
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 Shahid Beheshti University of Medical Sciences
Street address
Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-11-13, 1402/08/22
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.153

Health conditions studied

1

Description of health condition studied
Patients treated with Oral Anticoagulation Drug
ICD-10 code
T45.61
ICD-10 code description
Poisoning by, adverse effect of and underdosing of thrombolytic drugs

Primary outcomes

1

Description
Prothrombin Time and International Normalized Ratio (PT/INR)
Timepoint
Before and six weeks after the intervention
Method of measurement
Blood test

2

Description
Medication Adherences
Timepoint
Before and one month after the intervention
Method of measurement
Moriski medication adherence questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, basic and advanced trainings will be implemented based on the need and according to the results of the score obtained from the knowledge questionnaire of anticoagulant drugs. These trainings are related to the time to see a doctor, INR level check periods, the time to apply activity restrictions and the time to return to daily activities, drug side effects, self-care, patients' awareness of the drug, and factors affecting the treatment process with the help of pamphlets and face-to-face training on the interview day. In the second and fourth week, the applicants will receive training by phone.
Category
Other

2

Description
Control group: will receive only usual training and care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Fariba Bakhshayesh
Street address
Namazi Square, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
faribabakhshayesh815@gmail.com

2

Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Fariba Bakhshayesh
Street address
next to the Faculty of Medicine, Karim Khan Zand Blvd. Shiraz,
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۶۱۱۴
Phone
+98 71 3235 1099
Email
faribabakhshayesh815@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
urm@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Bakhshayesh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
faribabakhshayesh815@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsa Boozaripoor
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr St., Niayesh Highway Intersection, Opposite Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
emettis@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fariba Bakhshayesh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tehran, Vali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
faribabakhshayesh815@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
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