Reduce anxiety and blood sugar in the elderly diabetic patients
Design
Two intervention and control groups with a sample size of 100 people randomly divided into two groups
Settings and conduct
Training sessions at the Qotb al-Din Diabetes Association
Participants/Inclusion and exclusion criteria
Diagnosed type II diabetes; not receiving training in life skills since diagnosis; ability to attend group meetings; at least six months have been diagnosed as having an elderly type 2 diabetes
Intervention groups
Stress management training is to the intervention group that has 60-year-olds with type 2 diabetes
Main outcome variables
Anxiety , blood sugar level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111017007816N17
Registration date:2018-08-14, 1397/05/23
Registration timing:registered_while_recruiting
Last update:2018-08-14, 1397/05/23
Update count:0
Registration date
2018-08-14, 1397/05/23
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-09, 1396/02/19
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping with stress on anxiety and quality of life in elderly patients with diabetes referring to Shiraz health centers in 2017-18
Public title
The effect training of on anxiety and quality of life in elderly patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed type II diabetes
Not receiving training in life skills since diagnosis
Ability to attend group meetings
At least six months have been diagnosed as having an Elderly type 2 diabetes
Exclusion criteria:
Type 1 diabetes
Under 60 years old
Do not tend to attend meetings
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.SUMS.REC.1397.151
Health conditions studied
1
Description of health condition studied
Type II diabetes
ICD-10 code
F00-09
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
Anxiety treatment
Timepoint
Before and 3 month after intervention
Method of measurement
Questionair
Secondary outcomes
1
Description
Blood glucose
Timepoint
Before and 3 month after intervention
Method of measurement
Lab test
Intervention groups
1
Description
Intervention group: in this group is for 6 sessions, each session lasting an hour and a half and just 1 session per week of interactive lectures practices and partnerships with educational aids, pamphlets, booklets .
Category
Lifestyle
2
Description
Control group: in control group was not intervention performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qutb al-Din clinic
Full name of responsible person
دکتر نسیمی
Street address
Shiraz Fakhr Abad Street
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3821 9638
Email
Tayebe.dastbas@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Street address
School of Public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Fax
+98 71 3752 6022
Email
manazari@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Tayyibeh Rahmani
Position
MSc. student
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
School of Public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 913 606 3537
Fax
+98 71 3752 6022
Email
Tayebe.dastbas@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahin Nazari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Eeducation & Promotion, School of Public Health , Shiraz University of Mediccal Sciences
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Fax
+98 71 3752 6022
Email
manazari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tayebe Rahmni
Position
MSc
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
School of Public Health, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 1725 1006
Fax
+98 71 3752 6022
Email
Tayebe.dastbas@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
The total number of people referring to the magazine in which the article was published
Under which criteria data/document could be used
Supervisor
From where data/document is obtainable
Dr. Mahin Nazari
Email manazari@sums.ac.ir
What processes are involved for a request to access data/document
The coordinator's author takes about 1 week to 1 month