Protocol summary

Summary
The main purpose of the project including evaluation of the effects of education based on health belief model on medication adherence in diabetic patients. This study is a randomized controlled trial, cross training trials on 130 patients referred to the diabetic clinic Arak city. Inclusion criteria including Diabetic patients 30 to 55 years; Diabetic patients without chronic complications such as retinopathy, nephropathy, neuropathy; Use of insulin; The use of anti-diabetic pills; Use of insulin and anti-diabetic pills; Exclusion criteria including if the patient is not willing to continue to cooperate; If the patient is moved from the city; the absence of ongoing diabetes education sessions; the unavailability of patients during the post-test questionnaire. The present study is done through the following steps: samples selection, pre-test using the questionnaire and determine the distribution of knowledge, severity, perceived benefits, perceived barriers, manuals, self-efficacy and performance of Compliance medication regimen before the intervention, intervention for a month, post - test through redistribution of questionnaires and interviews to determine the level of knowledge, severity, perceived benefits, perceived barriers, manuals, self-efficacy and performance in patients diabetes is 3 months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014082018522N2
Registration date: 2015-01-02, 1393/10/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-02, 1393/10/12
Registrant information
Name
Fahimeh Dastjani Farahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 255 8830
Email address
fahimeh.d6850@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Arak University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-08-27, 1393/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of education based on health belief model on medication adherence in diabetic pationts
Public title
The effect of education on adherence to drug regimen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients 30 to 55 years; Diabetic patients without chronic complications such as retinopathy, nephropathy, neuropathy and ...; Use of insulin; The use of anti-diabetic pills; Use of insulin and anti-diabetic pills; Exclusion criteria: if the patient is not willing to continue to cooperate; If the patient is moved from the city; the absence of ongoing diabetes education sessions; the unavailability of patients during the post-test questionnaire.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 130
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
Arak University of Medical Sciences
Street address
Vice Chancellor for Education and Research, Pardis Educational Complex, Basij Sq, Sardashat, Arak
City
Arak
Postal code
38481-7-6941
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
92-159-9

Health conditions studied

1

Description of health condition studied
Diabete
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

2

Description of health condition studied
Diabete
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

3

Description of health condition studied
Diabete
ICD-10 code
E13
ICD-10 code description
Other specified diabetes mellitus

4

Description of health condition studied
Diabete
ICD-10 code
E14
ICD-10 code description
Unspecified diabetes mellitus

Primary outcomes

1

Description
Self Efficacy
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

2

Description
External Practice Guide
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

3

Description
Perceived Barriers
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

4

Description
Perceived Benefits
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

5

Description
Internal Practice Guide
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

6

Description
Perceived Susceptibility
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

7

Description
Perceived Severity
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

8

Description
Adherence To Medication
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

9

Description
Glycosylated Hemoglobin
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Blood Biochemical Tests

10

Description
Fasting Blood Sugar
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Blood Biochemical Tests

11

Description
Awareness
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Awareness
Timepoint
Before The Experiment And Three Months After The Itervention
Method of measurement
Questionnaire

2

Description
Adherence To Medication
Timepoint
Before The Experiment And Three Months After The Itervention
Method of measurement
Questionnaire

3

Description
Glycosylated Hmoglobin
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Blood Biochemical Tests

4

Description
Fasting Blood Sugar
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Blood Biochemical Tests

5

Description
Perceived Susceptibility
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

6

Description
Perceived Severity
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

7

Description
Perceived Barriers
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

8

Description
Perceived Benefits
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

9

Description
Internal Practice Guide
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

10

Description
External Practice Guide
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

11

Description
Self Efficacy
Timepoint
Before The Experiment And Three Months After The Intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Education based on health belief model in case group consist of four sessions through lecture, and group discussion and dialog (question and answer). Data collection through self-reported questionnaires distributed at the pre-intervention and three months after intervention.
Category
Prevention

2

Description
Nonintervention in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Dr Mohsen Shamsi
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiee
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research 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
Msc
Full name of responsible person
Fahimeh Dastjani Farahani
Position
Arak University of Medical Sciences
Other areas of specialty/work
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3368 4615
Fax
Email
fahimeh.d6850@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
Dr Mohsen Shamsi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Public Health, Golestan Alley, Mustafa Khomeini Settlements, Arak
City
Arak
Postal code
Phone
+98 86 3368 6443
Fax
Email
mohsenshamsi1360@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Dastjani Farahani
Position
Msc
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij SQ, Sardashat
City
Arak
Postal code
Phone
00
Fax
Email
fahimeh.d6850@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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