Protocol summary

Summary
The high prevalence of diabetes and the importance of it"s long term monitoring in the elderly propound a low cost prevention and a practical method witch cause the depletion of chronic complication of the diseases. In between the Telenursing is counted as a simple and effective method. This study is a randomize clinical trial has will be running on the elderly who suffer from diabetes . Diabetic elderly divided in to 2groups by simple randomization. The control group which receive the normal aims and next group is called intervention group who in addition to take the normal care will take the telephone care for 3months. The telenursing content are related to diabetes issues and each patients complaining. After 3 months 2groups will compare.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061822320N4
Registration date: 2017-10-25, 1396/08/03
Registration timing: na

Last update:
Update count: 0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Not enough for processing
Funding source
Rafsanjan university of medical science
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the Effect of telenursing on glycemic control of diabetes in elderly patients
Public title
Survey of the Effect of telenursing on glycemic control of diabetes in elderly patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion:elderly with diabetes from rafsanjan (age above-60-years) -having telephone-auditory and speaking system is right- exclusion:Hospitalization at study time-no answer to telephone for 2 weeks at first month and 3 weeks at second and third month.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
After the first interview and taking FBS patients divided to two groups by simple randomization.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees of Rafsanjan university of medical sciences
Street address
Rafsanjan nursing and midwifery
City
Rafsanjan
Postal code
7718796755
Approval date
2017-05-09, 1396/02/19
Ethics committee reference number
IR.RUMS.REC.1396.39

2

Ethics committee
Name of ethics committee
Ethics Committees of Rafsanjan university of medical sciences
Street address
Nursing and midwifery
City
Rafsanjan
Postal code
7718796755
Approval date
2017-05-09, 1396/02/19
Ethics committee reference number
IR.RUMS.REC.1396.39

3

Ethics committee
Name of ethics committee
Ethics Committees of Rafsanjan university of medical sciences
Street address
Rafsanjan nursing and midwifery
City
Rafsanjan
Postal code
7718796755
Approval date
2017-05-09, 1396/02/19
Ethics committee reference number
IR.RUMS.REC.1396.39

Health conditions studied

1

Description of health condition studied
Diabetes mellituse
ICD-10 code
4
ICD-10 code description
E10-E14

2

Description of health condition studied
Diabetes
ICD-10 code
4
ICD-10 code description
E10-E14

Primary outcomes

1

Description
diabetes
Timepoint
3months
Method of measurement
mg per decilitere

2

Description
HbA1C-FBS
Timepoint
before intervention-3months after intervvention
Method of measurement
mg per decilitere

3

Description
HbA1C-FBS
Timepoint
before hntervention-3months after
Method of measurement
mg per decilitere

Secondary outcomes

1

Description
BMI
Timepoint
befor intervention-3months after
Method of measurement
divided weight to height

2

Description
age
Timepoint
3months
Method of measurement
year

3

Description
BMI
Timepoint
before intervention-3months after intervention
Method of measurement
weight divided heihht

Intervention groups

1

Description
diabetes control edjucation
Category
Prevention

2

Description
education diabetes control
Category
Prevention

3

Description
diabetes control edjucation
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan diabetes clinic
Full name of responsible person
Ali ravari
Street address
emam ali blv
City
Rafsanjan

2

Recruitment center
Name of recruitment center
dibetes clinic
Full name of responsible person
ali ravari
Street address
emam ali bulvarde
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for reseach of Rafsanjan university of medical sciences
Full name of responsible person
Ali ravari
Street address
emam ali blv
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for reseach of Rafsanjan university of medical sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
vice chancellor for reseach of Rafsanjan university of medical sciences
Full name of responsible person
Ali ravari
Street address
emam ali blv
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for reseach of Rafsanjan university of medical sciences
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
vice chancellor for reseach of Rafsanjan university of medical sciences
Full name of responsible person
Ali ravari
Street address
emam ali bulvarde
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for reseach of Rafsanjan university of medical sciences
Proportion provided by this source
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan university of medical science
Full name of responsible person
Ali ravari
Position
nursing phd
Other areas of specialty/work
Street address
emam ali bulvarde-central institute
City
Rafsanjan
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
ravary4776@yahoo.com
Web page address
www.rums.ac.ir

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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