The effect of telenursing training on the basis of family-center empowerment model on the compliance to regimen treatment rate among patients with type 2 diabetes: a randomized clinical trial
The effect of tele-nursing training on the basis of family-center empowerment model on the compliance to regimen treatment rate among patients with type 2 diabetes: a randomized clinical trial
Design
This study is a non-blinded clinical trial. The study population will be included all patients who referring to the diabetes ward of Al-Zahra hospital of Gilane Gharb city. Sixty eligible patients will be selected conveniently and randomly will be assigned to two intervention groups.
Settings and conduct
This study which will be conducted in Al-Zahra hospital of Gilane Gharb city is a nonblinded one. Questionnaire of compliance to regimen treatment will be provided to the patients at the beginning and at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least six months passed from the diagnosis of type 2 diabetes; age between 30-55 years old; definitive diagnosis of type 2 diabetes by a doctor. Exclusion criteria: severe debilitating complications associated with diabetes.
Intervention groups
The intervention group over 16 sessions (2 times per week for telenursing weeks) for 20 to 30 minutes will receive telenursing training. The control group will not receive any training.
Main outcome variables
Adherence to the regimen treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N115
Registration date:2019-03-06, 1397/12/15
Registration timing:prospective
Last update:2019-03-06, 1397/12/15
Update count:0
Registration date
2019-03-06, 1397/12/15
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telenursing training on the basis of family-center empowerment model on the compliance to regimen treatment rate among patients with type 2 diabetes: a randomized clinical trial
Public title
The effect of telenursing training on the basis of family-center empowerment model on the compliance to regimen treatment rate among patients with type 2 diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months passed from the diagnosis of type 2 diabetes
Age between 30-55
Definitive diagnosis of type 2 diabetes by doctor
The patient lives with the family
Exclusion criteria:
Severe debilitating complications associated with diabetes
Age
From 30 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
ir.kums.rec.1397.1010
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Adherence to the regimen treatment
Timepoint
At the beginning and at the end of the study (2 months after the start of the study)
Method of measurement
Using questionnaires of adherence to treatment
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group over 16 sessions (2 times per week for 8 weeks) for 20 to 30 minutes will receive telenursing training.
Category
Lifestyle
2
Description
The control group will not receive any training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Negar Shahabi
Street address
Basij Boulevard
City
GilanGharb
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 4322 3502
Email
shahabi.neg@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Negar Shahabi
Position
MSc Student Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 8588
Email
shahabi.neg@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parvin Abassi
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 8588
Email
p_abasi2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negar Shahabi
Position
MSc Student Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 8588
Email
shahabi.neg@yahoo.com
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail