Protocol summary

Summary
The aim of this study was to determine the impact of pharmaceutical boxes on medication adherence in patients treated with warfarin. Inclusion criteria included: cardiovascular disease approved by the doctor, taking warfarin, ability to use of drugs, having aged between 40 and 60 years. Exclusion criteria included Failure to provide complete information and incomplete questionnaires. This study is a clinical trial. 70 patients taking warfarin were randomly divided into two groups. The intervention group was given a medication reminder box for 30 day. Then follow the drug warfarin levels and medication adherence.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010914229N4
Registration date: 2016-02-03, 1394/11/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of pharmaceutical box on medication adherence in patients treated with warfarin
Public title
The impact of pharmaceutical box on medication adherence in patients treated with warfarin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included: cardiovascular disease approved by the doctor; taking warfarin; ability to use of drugs; having aged between 40 and 60 years. Exclusion criteria included: Failure to provide complete information; incomplete questionnaires: unwillingness to provide blood samples for testing; and any physical or mental disability.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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 Arak University of Medical Sciences
Street address
Basij Sq. Arak
City
Arak
Postal code
3819693345
Approval date
2015-05-06, 1394/02/16
Ethics committee reference number
IR.ARAKMU.REC.1394.26

Health conditions studied

1

Description of health condition studied
drug adherence
ICD-10 code
Z72.2
ICD-10 code description
Drug use

Primary outcomes

1

Description
Drug adherence
Timepoint
Before and after 30 days
Method of measurement
Medication Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Group 1 (intervention) using medication reminder box to warfarin for 30 days
Category
Prevention

2

Description
Group 2 (control): In this group, do not interfere.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Hadi Jafari Manesh
Street address
Sardasht Sq. Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
Basij Sq. Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com jafarimanesh@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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