In this research we have aimed at studying the effectiveness of group motivational interviewing among type 2 diabetic patients. We wanted to know whether it can be effective on glycemic control as well as the patient’s satisfaction. The main inclusion criteria to this study are diagnosis of type 2 diabetes and glycosylated hemoglobin equal or higher than 7. Exclusion criteria are psychotic or other severe mental disorders.
The research population consists of all patients with diagnosis of type 2 diabetes with age between 30 to 60, that are under treatment during the research in diabetes clinic and other related outpatient centers in Zanjan-Iran. The sample size will be 30 patients. These patients will randomly allocate into two equal experimental and control groups. Intervention would be four weekly sessions of group motivational interview, each session 90 minutes. The assessments includes lab tests (fasting blood glucose and glycosylated hemoglobin), as well as diabetes treatment satisfaction questionnaire. These assessments will be done on both groups, three times including pre-test, post-test, and follow up.
If we find group motivational interview effective in glycemic control of the diabetic patients, we can propose this intervention as a part of diabetes management.
General information
Acronym
MI
IRCT registration information
IRCT registration number:IRCT2015110724923N1
Registration date:2016-07-12, 1395/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Chiman Salimi
Name of organization / entity
University of Science and Culture
Country
Iran (Islamic Republic of)
Phone
+98 21 4421 4713
Email address
chiman@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Social Determinants of Health Research Center. Zanajn University of Medical Sciences
Expected recruitment start date
2016-02-06, 1394/11/17
Expected recruitment end date
2016-02-16, 1394/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Motivational interview as group therapy for glycemic control and treatment satisfaction of type 2 diabetic patients in Zanjan-Iran
Public title
Motivational interview as group therapy for type 2 diabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Diagnosis of type 2 diabetes mellitus by an internist or endocrinologis; tUsing diabetes medications; HbA1C = 7 or higher; Age range between 30 and 60; Education level at least high school;Signing informed written consent
Exclusion criteria:Psychotic or other severe mental problems; Drug abuse; Cognitive deficits; Gestational diabetes
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan univercity of midical seinces, Deputy of research
Street address
Azadi boulevard
City
Zanjani
Postal code
Approval date
2015-09-15, 1394/06/24
Ethics committee reference number
ZUMS.REC.1394.140
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus Type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Glycosylated hemoglobin
Timepoint
pre-test (one week before the first session), post-test (a week after the last session), and follow up (two months after post-test)
Method of measurement
blood test
2
Description
Fasting blood
Timepoint
pre-test (one week before the first session), post-test (a week after the last session), and follow up (two months after post-test)
Method of measurement
blood test
3
Description
Treatment Satisfaction
Timepoint
pre-test (one week before the first session), post-test (a week after the last session), and follow up (two months after post-test)
after the final session of motivational interviewing
Method of measurement
client satisfaction questioner (CSQ)
Intervention groups
1
Description
Intervention would be four weekly sessions of group motivational interview, each session 90 minutes. The assessments includes lab tests (fasting blood glucose and glycosylated hemoglobin), as well as diabetes treatment satisfaction questionnaire. These assessment will be done in three times including pre-test, post-test, and follow up.
The control group does not any receive intervention. The assessments in control group includes lab tests (fasting blood glucose and glycosylated hemoglobin), as well as diabetes treatment satisfaction questionnaire. These assessments will be done in three times including pre-test, post-test, and follow up.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Diabetic Clinic and other related outpatient centers
Full name of responsible person
Chiman Salimi
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Social Determinants of Health Research Center. Zanajn University of Medical Sciences
Full name of responsible person
Mazlomzadeh
Street address
Zanjan, the highway Sheikh Fazlullah Nuri, Vali-Asr Hospital, Institute of Metabolic Diseases, Second Floor, Centre for Research on Social Determinants of Health.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Social Determinants of Health Research Center. Zanajn 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
Zanjan univercity of medical sciences
Full name of responsible person
Chiman Salimi
Position
Mastar of clinical psychology
Other areas of specialty/work
Street address
Behishty hospital
City
Zanjan
Postal code
Phone
+98 24 3354 4001
Fax
Email
Chiman@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan univercity of medical Sciences
Full name of responsible person
Chiman Salimi
Position
Mastar of clinical psychology
Other areas of specialty/work
Street address
Behishti hos[pital
City
Zanjan
Postal code
Phone
+98 24 3354 4001
Fax
Email
chiman@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan Univercity of Medical Sciences
Full name of responsible person
Chiman Salimi
Position
Master of Clinical Psychology
Other areas of specialty/work
Street address
Beheshti Hospital
City
Zanjan
Postal code
Phone
+98 24 3344 0301
Fax
Email
Chiman@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)