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Effectives of educational intervention based on temporal self- regulation theory in Adherence to medication in adults with Rheumatoid arthritis in Velayat hospital Qazvin

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History
# Registration date Revision Id
2 2023-05-24, 1402/03/03 267844
1 2018-06-30, 1397/04/09 50914
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  • General information

    Double blinded
    Single blinded
    1
    1
    empty
    200
    empty
    2018-07-02, 1397/04/11
    empty
    2018-09-30, 1397/07/08
    empty
    2019-05-31, 1398/03/10
    empty
    update trial status
    empty
    به روز رسانی وضعیت کارازمایی.
    This study is based on a temporary self-regulation theory, which is one of a number of new theories in changing the behavior of individuals, and studies based on theories are very limited.
    این مطالعه بر اساس تئوری خودتنظیمی موقت صورت میگیرد که یکی از انواع تئوریهای جدید در تغییر رفتار افراد محسوب می شود و مطالعات براساس تئوریها بسیار محدود است
    After filling the consent sheet, the participants are randomly divided into two groups of intervention and control according to the stata software, and none of the companies know which group is involved in intervention or control.
    After filling the consent sheet, the participants are randomly divided into two groups of intervention and control according to the stata software. The research assistants and the biostatistician will be blinded to patient allocation groups.
    شرکت کنندگان پس از پر کردن برگه رضایتنامه بطور تصادفی براساس نرم افزار stata به دو گروه مداخله و کنترل تقسیم بندی می شوند وهیچ یک ازشرکت کنندگان نمی دانند که در کدام گروه مداخله یا کنترل قرار گرفته اند
    پس از تکمیل رضایت نامه، شرکت کنندگان بر اساس نرم افزار stata به طور تصادفی به دو گروه مداخله و کنترل تقسیم می شوند. دستیاران پژوهشی و متخصص آمار زیستی نسبت به گروه های تخصیص بیمار کور خواهند شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Velayat Hospital
    Name of recruitment center - Persian: بیمارستان ولایت
    Full name of responsible person - English: shahnaz asgari ghoncheh
    Full name of responsible person - Persian: شهناز عسگری غنچه
    Street address - English: Qazvin -Minodar - Feb. 22 boulevard-Elahieh
    Street address - Persian: قزوین -مینودر - بلوار 22 بهمن -الهیه
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3414867587
    Phone: +98 28 3379 0610
    Fax:
    Email: sh.asgari63@yahoo.com
    Web page address:
    Name of recruitment center - English: Velayat Hospital
    Name of recruitment center - Persian: بیمارستان ولایت
    Full name of responsible person - English: Shahnaz Asgari Ghoncheh
    Full name of responsible person - Persian: شهناز عسگری غنچه
    Street address - English: Elahiyeh, 22 bahman blvd, Minodar, Qazvin
    Street address - Persian: قزوین -مینودر - بلوار 22 بهمن -الهیه
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3414867587
    Phone: +98 28 3379 0610
    Fax:
    Email: sh.asgari63@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Booali Sina Hospital
    Name of recruitment center - Persian: بیمارستان بوعلی سینا
    Full name of responsible person - English: Shahnaz Asgari Ghoncheh
    Full name of responsible person - Persian: شهناز عسگری غنچه
    Street address - English: Bou Ali Sina
    Street address - Persian: خیابان بوعلی سینا
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3413786165
    Phone: +98 28 3333 2930
    Fax:
    Email: sh.asgari63@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Pakpour Haji Agha
    Full name of responsible person - Persian: امیر پاکپور حاجی آقا
    Street address - English: Ghazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
    Street address - Persian: قزوین - بلوار شهید باهنر - دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: کد پستی : 59811-3419
    Phone: +98 28 3333 6001
    Fax:
    Email: pakpour_amir@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amir Pakpour Haji Agha
    Full name of responsible person - Persian: امیر پاکپور حاجی آقا
    Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazin
    Street address - Persian: قزوین - بلوار شهید باهنر - دانشگاه علوم پزشکی قزوین
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 59811-3419
    Phone: +98 28 3333 6001
    Fax:
    Email: pakpour_amir@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the Effectives of educational intervention based on temporal self- regulation theory in Adherence to medication in adults with rheumatoid arthritis in velayat hospital Qazvin
Design
This research is a randomized controlled trial. 200 patients referred to the rheumatology clinic of Velayat hospital are included in this study. Patients were randomly divided into two groups of control and intervention.Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
200 patients with arthritis rheumatoid who had been referred to the Rheumatology Clinic of Velayat Hospital for following their treatments are enrolled in this study. This study is conducted in Qazvin Velayat Hospital, and patients are randomly assigned to intervention and control groups. This research is two-blinded.
Participants/Inclusion and exclusion criteria
The definite diagnosis of rheumatoid arthritis confirmed by a specialist, the absence psychological problems before the onset of rheumatoid arthritis, the absence of other chronic , satisfaction to participate in the study, have a minimum level of education reading and writing
Intervention groups
In this study, the target group will be trained by the researcher for 3-5 minutes, group sessions for 50 minutes. In the control group, interventions are administered routinely by hospital doctors. These interventions are limited to educational intervention related to increased awareness and sensitivity to regular drug use.
Main outcome variables
The impact on Medication adherence

General information

Reason for update
update trial status
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038271N1
Registration date: 2018-06-30, 1397/04/09
Registration timing: prospective

Last update: 2023-06-12, 1402/03/22
Update count: 1
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Shahnaz Asgari ghoncheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3367 4283
Email address
sh.asgari63@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-03, 1396/11/14
Expected recruitment end date
2018-08-05, 1397/05/14
Actual recruitment start date
2018-07-02, 1397/04/11
Actual recruitment end date
2018-09-30, 1397/07/08
Trial completion date
2019-05-31, 1398/03/10
Scientific title
Effectives of educational intervention based on temporal self- regulation theory in Adherence to medication in adults with Rheumatoid arthritis in Velayat hospital Qazvin
Public title
Effectives of Adherence to medication in Rheumatoid arthritis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of rheumatoid arthritis with confirmation by a specialist No known psychological problems including depression Treated psychedelic drugs before having rheumatoid arthritis Lack of chronic and other dangerous diseases Have at least reading and writing skills
Exclusion criteria:
Cancellation Participate in other educational studies Inability to read and write Inability to take medication independently
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 200
Actual sample size reached: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done individually and its tool is Stata statistical software
Blinding (investigator's opinion)
Single blinded
Blinding description
After filling the consent sheet, the participants are randomly divided into two groups of intervention and control according to the stata software. The research assistants and the biostatistician will be blinded to patient allocation groups.
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
Qazvin University of Medical Sciences, Shahid Bahonar Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.QUMS.REC.1396.388

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.611
ICD-10 code description
Rheumatoid arthritis of right shoulder with involvement of other organs and systems

Primary outcomes

1

Description
Medication of Adherence for rheumatoid arthritis
Timepoint
Before the intervention, 3 and 6 months after the intervention began
Method of measurement
Medication of Adherence questionnaire

Secondary outcomes

1

Description
Quality of life Index
Timepoint
Before the intervention, 3 and 6 months after the intervention began
Method of measurement
Quality of Life Questionnaire 12 questions

2

Description
Anxiety and depression Index
Timepoint
Before the intervention, 3 and 6 months after the intervention began
Method of measurement
Anxiety Inventory - Depression

3

Description
Disability Index
Timepoint
Before the intervention, 3 and 6 months after the intervention began
Method of measurement
Health Assessment Questionnaire-Disability Index

4

Description
Temporary self-regulatory Index
Timepoint
Before the intervention, 3 and 6 months after the intervention began
Method of measurement
Temporary self-regulatory questionnaire

Intervention groups

1

Description
"Intervention group": Patients referring to Rheumatology Clinic of Velayat Hospital. Interventions are provided as training sessions for treating patients with rheumatoid arthritis
Category
Behavior

2

Description
"Control group": Patients referring to Rheumatology Clinic of Velayat Hospital In the control group, brief training is given on the disease
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Shahnaz Asgari Ghoncheh
Street address
Elahiyeh, 22 bahman blvd, Minodar, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3414867587
Phone
+98 28 3379 0610
Email
sh.asgari63@yahoo.com

2

Recruitment center
Name of recruitment center
Booali Sina Hospital
Full name of responsible person
Shahnaz Asgari Ghoncheh
Street address
Bou Ali Sina
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Email
sh.asgari63@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Pakpour Haji Agha
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazin
City
Qazvin
Province
Qazvin
Postal code
59811-3419
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.com
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
Amir Pakpour Haji Agha
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.com

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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Bahonar Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
pakpour_amir@yahoo.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effectives of educational intervention based on temporal self- regulation theory in Adherence to medication in adults with Rheumatoid arthritis in Velayat hospital Qazvin. Participants data file and clinical report and report will be available to enthusiasts after the end of the work in general and after unidentified people.
When the data will become available and for how long
Start the access period 12 months after printing the results
To whom data/document is available
The data will only be available to scholars working in academic and scientific institutions
Under which criteria data/document could be used
Overall analysis and comparison and correct referral
From where data/document is obtainable
To the researcher, please refer to sh.asgari63@yahoo.com
What processes are involved for a request to access data/document
First, give a request to the researcher and the researcher will inform the supervisor and then the data will be available to the interested party.
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