Protocol summary

Summary
This study aims to determine the effects of implementing empowerment program and empowerment with telenursing on self-efficacy, quality of life and Glycosylated hemoglobin of type 2 diabetes . The most important inclusion criteria are the presence of type 2 diabetes (at least one year), the age range of 30-70 years, and residence in Tabriz city. The most important exclusion criteria are hospitalization during the study period, disconnection for 2 weeks In the first month of intervention and 3 weeks in the second and third months of the study. The sample size in this study is based on the level of observed effect size through empowerment intervention on the self-efficacy score of the diabetic patients in the previous similar studies, which with the power of 90%, was calculated 43 for each group, and considering 20% loss, it will increase to 52 people. Using the sites related to stratified random sampling, the qualified individuals will be classified in three groups 1 (empowerment), the intervention group 2 (empowerment program with telenursing ) and the control group. For groups 1 and 2, the empowerment program will be held for 2 weeks following the application of pretest. For the intervention group 2, telenursing program will be held for 12 weeks. Post-test for the three groups will be held after 14 weeks. In other words, three variables of self-efficacy, quality of life and glycosylated hemoglobin are measured in weeks 0 and 14.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608276918N25
Registration date: 2017-08-22, 1396/05/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Medical University of Sincece
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of empowerment program implementation with and Without telenursing on Self-efficacy and Quality of life of and Glycosylated hemoglobin index in Type II Diabetic patients : A double-blind randomized clinical trial
Public title
Implementation of empowerment program along with telenursing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with type II diabetes aged 30 to 70 years; having diabetes for at least one year; conscious patients able to communicate; lack of speech and hearing problems, lack of participation in educational programs of other diabetes educational centers; residing in Tabriz; having access to regular phone or mobile phones. Exclusion criteria: being hospitalized during the study period; disconnecting the phone for 2 weeks during the first month of intervention and 3 weeks during the second and third months of the study; people suffering from mental or psychological problems according to the patient; taking psychotropic drugs according to the patient; and in cases where the individuals have some reason not to attend the sessions
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tabriz University of Medical Science
Street address
Tabriz, Daneshgah St.
City
Tabriz
Postal code
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.TBZMED.REC.1396.436

Health conditions studied

1

Description of health condition studied
ِDiabet
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before intervention and 14 Week After Intervention
Method of measurement
Diabetes Self-efficacy Scale

Secondary outcomes

1

Description
Quality of life
Timepoint
Before intervention and 14 week after intervention
Method of measurement
Diabetis spesific QOL Questionnaire

2

Description
Glycosylated hemoglobin
Timepoint
Before intervention and 14 week after intervention
Method of measurement
Bionik kits, unit: percent

Intervention groups

1

Description
Educating of empowerment program without telenursing
Category
Behavior

2

Description
Educating of empowerment program with telenursing
Category
Behavior

3

Description
Without intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital in Tabriz
Full name of responsible person
Hadi Azhdari
Street address
Shariety South St. Tabriz Faculty of Nursing and Midwifery Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz, Azadi Street, Golgasht Street , headquarters of Tabriz University of Medical Sciences
City
Tabriz
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 of Tabriz 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
Tabriz Faculty of Nursing and Midwifery
Full name of responsible person
Hadi Azhdari
Position
Msn student
Other areas of specialty/work
Street address
Shariety South St. Faculty of Nursing & Midwifery
City
Tabriz
Postal code
5138947979
Phone
+98 41 3477 0648
Fax
Email
Hadiazhdari69@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shariety South St. Faculty of Nursing & Midwifery
Full name of responsible person
Faranek Jabbarzadeh Tabrizi
Position
PhD of Nursing
Other areas of specialty/work
Street address
Tabriz Faculty of Nursing & Midwifery
City
Tabriz
Postal code
5138947979
Phone
+98 41 3477 0648
Fax
Email
jabbarzadehf@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Azhdari
Position
Msn student
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing and Midwifery of Tabriz
City
Tabriz
Postal code
5138947979
Phone
+98 41 3477 0648
Fax
Email
hadiazhdari69@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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