Objective: Determining the family-oriented training on the quality of life of the patients with type 2 diabetes.
The studied group was the patients with type 2 diabetes. The sample size is 40 patients in every group. The samples were selected using random sampling method and divided into control and test groups randomly. The training course includes three 1-hour and thirty minutes session in 3 successive days. The phone follow up continues until the post-test implementation three months after the intervention. The inclusion criterion for this study is the patients with type 2 diabetes with the minimum age of 18 years old. The exclusion criterion is the absence of the patient and his family from one of the training sessions. The training curriculum includes three successive sessions with the patient and one of his family members in the test group and the patient himself in the control group. To compare the test and control groups after three months, the effect of the training course on quality of life of the patients will be investigated using post-test. The primary outcome is the patient’s quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092210899N1
Registration date:2013-02-01, 1391/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-01, 1391/11/13
Registrant information
Name
Zahra Ashrafi
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 3600
Email address
n_ashrafi.nursing@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-25, 1391/04/05
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the impact of family-based education on quality of life of patients with type 2 diabetes
Public title
Impact of family education on quality of life of diabetic patient
Purpose
Other
Inclusion/Exclusion criteria
The inclusion criteria: the doctor and the diagnostic tests’ results should confirm the disease diagnosis. At least, 6 months should have passed the diagnosis. The patient or one of his family members should be educated. They should understand Persian language. The patient or his family members should not have received any formal education. The patient should not suffer type 1 diabetes. The minimum age of the patient should be 18 years old. The exclusion criteria: the patient and his family do not want to cooperate anymore. The patient and his family do not attend one of the training sessions. The patient and his family have attended other organizations’ formal training.
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples are allocated to groups control and interventional.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of TUMS, Keshavarz Blvd, Tehran, Iran
The training course consists of three successive sessions with the patient and one of his family members in the test group and the formulated content would be taught in three 1-hour and thirty minutes sessions in 3 successive days. The training content includes: explaining the disease and its implications and the importance of having information to control the disease; the increase and decrease of blood sugar level (first session); how to take the medication; how to inject insulin (the way to calculate the doses, the way to fill the syringe and so on); how to use the urine sugar test strips and glucometer (second session); diet and exercise and their role in controlling diabetes; and preventing the disease complications (third session). Afterwards, phone follow up would continue every two weeks. In order to compare the test and control groups after three months, the effect of training course on quality of life will be investigated through posttest.
Category
Other
2
Description
In the control group, the training course includes three successive sessions with the patient. The formulated content would be taught in three 1-hour and thirty minutes sessions in three successive days and at the beginning of the first session pretest and at the end the posttest would be taken from the topics of interest to confirm the effect of the presented training. The training content includes explaining the disease and its implications and the importance of being informed to control the disease, and reduce the symptoms and increasing of the blood sugar level (first session); how to take the medication, how to inject insulin (how to calculate the doses, how to fill the syringe and so on); how to use the urine sugar test strips and glucometer (second session); diet and exercise and their role in controlling diabetes; and preventing the disease complications (third session). Afterwards, phone follow up would continue every two weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Daryadokht Masror Rudsary
Street address
Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Sixth Floor, Central Organization of TUMS, Keshavarz Blvd, Tehran, Iran
City
Tehran
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, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Daryadokht Masror Rodsari
Position
Faculty member of Nursing and Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Fax
Email
Daryadokht_masror@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Ashrafi
Position
Master of Science
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Fax
Email
n_ashrafi.nursing@yahoo.com/z-ashrafi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Daryadokht Masror Rodsari
Position
Faculty member of Nursing and Midwifery of TUMS
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq. Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6693 3600
Fax
Email
Daryadokht_masror@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)