Protocol summary

Summary
In present study, for determining the effect of intervention based on partnership care model on self concept of diabetic patients, 60 participants of adult diabetic type 2 referring to Imam Reza in Mashhad will be selected by convenience sampling and will be allocated to intervention and control groups. Inclusion criteria: age between 21-60 years; at least six months history of disease; not history of hospitalization one month before study. The self concept of participants in both groups will determine at first and three month later by Beck’s Self Concept Test. To conduct this study, the intervention group will divide to three groups include 10 people. Then the interventions will happen by lecture and providing pamphlet, during three months in 6 sessions with two week interval, by teamwork of nurse, physician, and patient in intervention group. The aim of these session is providing care based on partnership care model stages (motivation, preparing, involving and evaluation) and finally improving the self concept of patients. During the intervention, session date will be reminded them by telephone. The control group will receive routine care during three months. The Self Concept questionnaire will offer before and two weeks after last teaching session for patients. The control group will complete the questionnaires in similar time intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015071522682N3
Registration date: 2015-10-09, 1394/07/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-09, 1394/07/17
Registrant information
Name
Mahsa Moazzen Ahmadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3514
Email address
moazzenm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-07-14, 1394/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention based on partnership care model on self-concept promotion in patients with diabetes type 2
Public title
The effect of intervention based on partnership care model on self-concept promotion in patients with diabetes type 2
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in this study; age between 21-60 years; definite diagnosis of diabetes type 2 based on patients dossiers; not history of hospitalization one month before study; at least six months history of disease; absence of physical (cancer, chronic disease, ...) psychological (depression, schizophrenia, ...) disease affecting on self concept; not pregnant; lack of learning disabilities; lack of disasters event in the past six months Exclusion criteria: presence of crisis or unexpected incident during the intervention; giving up for continuing participation in study; absence in more than once training sessions or following.
Age
From 21 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian road border, Gonabad, Khorasan Razavi
City
Gonabad
Postal code
9691793718
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.GMU.REC.1394.23

Health conditions studied

1

Description of health condition studied
diabete type 2
ICD-10 code
E10- E11-
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Self-Concept
Timepoint
before intervention, after intervention
Method of measurement
Beck Self-Concept Test

Secondary outcomes

empty

Intervention groups

1

Description
The interventions will happen by lecture and providing pamphlet, during three months in 6 sessions with two week interval, by teamwork of nurse, physician, and patient in intervention group. The aim of these session is providing care based on partnership care model stages (motivation, preparing, involving and evaluation) and finally improving the self concept of patients.
Category
Other

2

Description
In control group, routine care will be conducted.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam zaman Hospital of Mashhad
Full name of responsible person
Mahdi Heidary Marghzar
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mosa Sajjadi
Street address
Gonabad University of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mousa Sajjadi
Position
PHD in nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
sajjadi1975@gmail.com
Web page address
www.gum.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Heidary Marghzar
Position
Master of nursing
Other areas of specialty/work
Street address
Imam Zaman Hospital
City
Mashhad
Postal code
9177167961
Phone
+98 51 3821 1751
Fax
+98 51 5252 1817
Email
moazzenm2@mums.ac.ir; heidarymarghzar@gmail.com
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Heidary Marghzar
Position
Master of nursing
Other areas of specialty/work
Street address
Imam Zaman Hospital
City
Mashhad
Postal code
9177167961
Phone
+98 51 3821 1751
Fax
+98 51 5252 1817
Email
moazzenm2@mums.ac.ir; heidarymarghzar@gmail.com
Web page address
www.mums.ac.ir

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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