Protocol summary

Summary
This clinical trial study aimed to determine the effects of telenursing on HbA1C in elderly with diabetes type 2. All of elderly with diabetes at least 60 years old are the research population. Include criteria are the participants with past history of diabetes at least 6 months and without any cognitive disorders. If a change in type or dose of him/her drugs, hospitalization during the study and have an HbA1C less than 7 they will exclude from the study. Eighty people with abnormal HbA1C trough randomized classified sampling method using random numbers table, design in two groups 1&2 So that the participants do not already know which control or intervention group will take place. In this study participants and researcher are blind. For group 1, telenursing with using telephone follow-up will conduct at least 3 months and group 2 will receive only usual cares. HbA1C will check in two times, before and after the intervention. Average changes of HbA1C in before and after intervention in two groups will discuss at a significant level.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060628289N1
Registration date: 2017-11-07, 1396/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Mohammad Esmaeilpour-Bandboni
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13565071
Email address
m_esmaeilpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Telenursing on HbA1c in elderly patients with type II diabetes
Public title
Tاhe effects of telenursing on diabetes control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age>60y; past history of diabetes at least 6 months; willingness to participate in study; have a good literacy with a call number; and without any cognitive disorders; speech and hearing problems Exclusion criteria: Change in type or dose of him/her drugs; hospitalization during study; have a HbA1C less than7
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethical commitee of Guilan University of Medical Sciences
Street address
Building of Vice chancellor for research, Facing Sepah Bank, West Shahid Beheshti Blvd, Rasht, Guilan, Iran
City
Rasht
Postal code
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
IR.GUMS.REC.1396.72

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
A1C
Timepoint
Before intervention and 3 month later
Method of measurement
Blood sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: They will receive 12 weeks telephone follow up, which will include eight times. Each time, for last 15 minutes, and we will talk regarding eight educational items according to the Iranian health ministry diabetes educational package. This educational package includes: types of diabetes, a diet that increases and decreases blood glucose, diabetic diet planning, blood glucose measurements, complications of diabetes, preventing complications of diabetes, self-care in diabetes, and the last one is the exercise in diabetes. Through every call, we should talk regarding one educational topic and so answer to him/her questions.
Category
Other

2

Description
Control group: During the twelve weeks, the control group received only the usual care for their treatment and intervention was not taken.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi-Internal Medicine Hospital of Guilan University
Full name of responsible person
Anosh Dehnadi
Street address
Razi-Internal Medicine Hospitalof Guilan University, Sardar AVE, Rasht, Guilan, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr shadman Nemati
Street address
Building of Vice chancellor for research, Facing Sepah Bank, West Shahid Beheshti Blvd, Rasht, Guilan, Iran
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences, Rasht, Iran
Full name of responsible person
Dr Mohammad esmaeilpour-Bandboni
Position
PhD
Other areas of specialty/work
Street address
Central Office of Guilan University of Medical Sciences, Parastar St., Rasht, I.R. Iran
City
Rasht
Postal code
4477163485
Phone
+98 13 3332 4168
Fax
+98 13 3332 4169
Email
esmaeilmmm@yahoo.com
Web page address
http://www.gums.ac.ir/3025/About-us.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences, Rasht, Iran
Full name of responsible person
Dr Mohammad Esmaeilpour-Bandboni
Position
PhD
Other areas of specialty/work
Street address
Guilan University of Medical Sciences, Rasht, Iran
City
Rasht
Postal code
Phone
+98 13565071
Fax
Email
esmaeilmmm@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences, Rasht, Iran
Full name of responsible person
Dr Mohammad Esmaeilpour-Bandboni
Position
PhD
Other areas of specialty/work
Street address
Guilan University of Medical Sciences,َAzodi street, Rasht, Iran.
City
Rasht
Postal code
Phone
00
Fax
Email
esmaeilmmm@yahoo.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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