Protocol summary

Summary
This Study Was Conducted With The Goal Of Determining The Effect Of Community Health Nurses’ Educational Intervention On The Self-Care Of The Patients With Type 2 Diabetes Who Referred To Hazrat Ali Clinic In Isfahan. The Inclusion Criteria Were Comprise Patients With Type 2 Diabetes, With A Mean Age Of 40–70 Years, Who Had A Medical Record In The Health Care Center And Were Under The Coverage Of Hazrat Ali Clinic And Exclusion Criteria Were Comprise Unwillingness Of Patient To Continue Cooperation In Educational Intervention. The Study Population Were All Patients With Type 2 Diabetes. Sampling Was Completed With Using The Pocock Formula And The Results Of The Pilot Study And A Total Of 50 Subjects Were Selected And Assigned To Two Groups Of Study And Control(25 In Each Group ). Educational Intervention Was Conducted In The Study Group Through Seven Educational Sessions And The Control Group Underwent An Educational Session And Was Given A Self-Care Educational Booklet. Primary Outcome Was The Mean Score Of Self Care After The Intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014062417315N2
Registration date: 2014-07-23, 1393/05/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-23, 1393/05/01
Registrant information
Name
Batool Hedayati
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7124
Email address
keshvari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Public Health Nurses’ Educational Intervention On Self Care Of The Patients With Type Two Diabetes
Public title
Effect Of Self Care On Type Two Diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Mean Age Of 40-70 Years; All Patients With Diabetes Type Two Had A File In Center; Exclusion Criteria: Lack Of Interest For Continuing The Completion Of Research Tools; Lack Of Participation In Group Discussion Meetings And Educational Partnership Programs;
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University Of Medical Sciences
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Postal code
81726-73461
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
292198

Health conditions studied

1

Description of health condition studied
Diabetes Type Two
ICD-10 code
E11
ICD-10 code description
Diabetes Mellitus

Primary outcomes

1

Description
Mean Score Of Self Care
Timepoint
2 MonthS
Method of measurement
Tobert And Glacow Brief Self Care Activities Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
For Experimental Group, The Educational Intervention Was Planned In Form Of Seven 30-40 Minute Sessions Held Twice A Week On Mondays And Wednesdays. Each Session Was Devoted To Educate One Of The Self Care Skills To The Patients
Category
Lifestyle

2

Description
For Control Group Underwent An Educational Session And Was Given A Self Care Educational Booklet
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Ali Clinic Center
Full name of responsible person
Batool Hedayati
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Kazemi, Ph.D. In Nursing
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Batool Hedayati
Position
Master Student of Community Health Nursing
Other areas of specialty/work
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran
City
Isfahan
Postal code
Phone
+31 52438054
Fax
Email
Parastaran2011@Yahoo.Com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Zandiyeh
Position
MSc Of Nursing
Other areas of specialty/work
Street address
Hezar Jarib Street, Faculty Of Nursing And Midwifery, Isfahan University Of Medical Sciences, Isfahan, Islamic Republic Of Iran.
City
Isfahan
Postal code
Phone
+98 31 3668 7153
Fax
Email
Zandiyeh@Nm.Mui.Ac.Ir
Web page address

Person responsible for updating data

Contact

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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