Comparison of the effectiveness of group reality therapy with a routine education program on adherence to the therapeutic regimen and improvement of health indicators in patients with Diabetes Type 2
Effectiveness of group reality therapy in comparison with hospital routine education on adherence to treatment regimen and health indicators in patients with type 2 diabetes
Design
The clinical trial included a control group with randomized parallel groups that was not blinded.
Settings and conduct
The study site is the Diabetes Center of Amir-Almonin Hospital in Ahvaz. After obtaining the code of ethics from the university ethics committee, the researcher selected 60 patients with diabetes based on the inclusion criteria and divided them into two groups of 30, then randomly assigned them to one of the two experimental or control groups. Questionnaires and tests were performed before the intervention. Then, group reality therapy training were performed for the experimental group and routine hospital training were performed for the control group. The instruments were measured again 2 month and 3 months after the intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria:
-Have at least literacy
-Failure to employ yourself, your spouse or first-degree relatives in health centers-Tendency to participate in the study
- At least two months have passed since the diagnosis of diabetes by the doctor -Not having a history of uncontrolled underlying diseases such as epilepsy -The patient has not taken any training in the field of reality therapy before
Exclusion criteria:
-Not attending more than one training session -Psychiatric treatments or the use of psychotropic drugs and substance abuse during research
Intervention groups
the intervention group was the patients with type 2 diabetes who referred to Amir Al-Monin Hospital and received group reality therapy. The control group also included patients who received routine education of hospital.
Main outcome variables
Outcomes include: changing patient health indicators; adherence to diabetes treatment regimens.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181210041915N2
Registration date:2020-10-06, 1399/07/15
Registration timing:retrospective
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Kourosh Zarea
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8071
Email address
zarea_k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-10, 1398/09/19
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
2019-12-10, 1398/09/19
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-03-18, 1398/12/28
Scientific title
Comparison of the effectiveness of group reality therapy with a routine education program on adherence to the therapeutic regimen and improvement of health indicators in patients with Diabetes Type 2
Public title
Group Reality Therapy on adherence to the therapeutic regimen and improvement of health indicators in Diabetes patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having minimum literacy skills
Not working, spouse or first-degree relatives in health centers
Willingness to participate in the study
At least two months have passed since diagnosis of diabetes
Not having a history of uncontrolled underlying diseases such as epilepsy
The patient has never received any training in the field of reality therapy
Exclusion criteria:
Not participating in more than one training session
Psychiatric treatments or the use of psychotropic drugs and substance abuse during study
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:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 60 patients referred to Amir Almonin Hospital in Ahvaz patients were selected based on inclusion criteria. Then they were allocated into two groups of 30 people (intervention group and the control group) by a coin randomly.
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
Ahvaz jundishapur university of medical sciences
Street address
Ahvaz Jundishapur university of medical sciences< Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.AJUMS.REC.1398.657
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Score of adherence to therapeutic regime based on questionnaire of adherence to therapeutic regime in patients with diabetes
Timepoint
The measurement of adherence to therapeutic regime was measured before the study, 1 and 2 months after the start of the group reality therapy.
Method of measurement
Questionnaire of adherence to therapeutic regime in patients with diabetes
2
Description
Primary variable was cholesterol levels.
Timepoint
The measurement of blood cholesterol level before the study, 1 and 2 months after the start of group reality therapy.
Method of measurement
Cholesterol level detection kit in the laboratory
3
Description
Primary variable was Blood Gloucester Hemoglobin( HBA1C) levels.
Timepoint
level of Blood Gloucester Hemoglobin (A1C Hb) before the study, 1 and 2 months after the start of the group reality therapy was measured.
Method of measurement
The HbA1C hemoglobin measurement kit in the laboratory was used
4
Description
Fasting Blood Sugar level
Timepoint
level of Fasting Blood Sugar before of the study, 1 and 2 months after the start of the group reality therapy was measured.
Method of measurement
The Fasting Blood Sugar measurement kit in the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The treatment protocol of the intervention group consisted of 10 sessions of 45 minutes (one session per week) for 2 months in the form of lectures and face-to-face training for the intervention group. Topics discussed in these sessions include information about diabetes, its causes and factors, how to take care of yourself, blood sugar control strategies, psychological support such as stress, anxiety, etc., strengthening positive thinking and ways Success, examining how to live better, etc. During each session, the topics and discussions of the previous sessions were also examined. The program of group reality therapy training sessions was based on the latest articles and books and consultations with experts based on Glaser's theory of choice and the theory of confrontation with the theory and was presented by the researcher with the help of the researcher (clinical psychologist). Then, the educational materials were provided to both groups in the form of educational booklets and CDs after the study. At the end of the training sessions, the intervention group was given the opportunity to apply new skills in their daily lives, during which the researcher contacted them by telephone and was given a telephone number to If necessary, call and raise their problems.
Category
Behavior
2
Description
Control group: In the control group, routine care include patient education, lab checkup that provided by the Diabetes Control Center of Amir-Almomenin hospital was used.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Almomenin hospital of Ahvaz
Full name of responsible person
kourosh zarea
Street address
Ahvaz Jundishapur university of medical sciences< Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8621
Email
zarea_k@ajusm.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur university of medical sciences<
City
Ahvaz
Province
Khouzestan
Postal code
6135864565
Phone
+98 61 3373 8621
Email
zarea_k@ajums.ac.ir
Grant name
Faculty member grant
Grant code / Reference number
NCRCCD-9829
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
kourosh zarea
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur university of medical sciences< Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
8764568981
Phone
+98 61 3373 8621
Email
zarea_k@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
kourosh zarea
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ahvaz Jundishapur university of medical sciences< Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
8764568981
Phone
+98 61 3373 8621
Email
zarea_k@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
kourosh zarea
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvaz Jundishapur university of medical sciences< Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
8764568981
Phone
+98 61 3373 8071
Fax
+98 61 3373 8333
Email
zarea_k@ajums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some sections of data if can not be identified I can provide to whom may use scientific purposes.
When the data will become available and for how long
6months later
To whom data/document is available
Scientific institutions
Under which criteria data/document could be used
No other one
From where data/document is obtainable
Ahvaz Jundishapur University of medical sciences
What processes are involved for a request to access data/document