The effects of nurse-led telephone follow-up (tele nursing) versus no follow-up on self-efficacy and quality of life in diabetic patients: a randomized clinical trial
To assess the effect of nurse-led telephone follow-up (tele nursing) versus no follow-up on self-efficacy and quality of life in diabetic patients
Design
This is a randomized clinical trial, phase II, in which 58 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible diabetic patients who will refer to telenursingDiabetes Center of Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Diabetes;
Access to telephone at home;
Residence of Hamadan City
Exclusion criteria:
Hearing problem
Intervention groups
Intervention group: Routine care and phone contact and training the patient for 5 to 10 minutes twice a week in the first month and then once a week in the second and third month
Control group: Just routine care
Main outcome variables
Primary outcome:
Assessing self-efficacy
Assessing the quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N249
Registration date:2018-11-18, 1397/08/27
Registration timing:prospective
Last update:2018-11-18, 1397/08/27
Update count:0
Registration date
2018-11-18, 1397/08/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of nurse-led telephone follow-up (tele nursing) versus no follow-up on self-efficacy and quality of life in diabetic patients: a randomized clinical trial
Public title
The effects of nurse-led telephone follow-up (tele nursing) versus no follow-up on self-efficacy and quality of life in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Diabetes;
Access to telephone at home;
Residence of Hamadan City
Exclusion criteria:
Hearing problem
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.UMSHA.REC.1397.439
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications
Primary outcomes
1
Description
Assessing self-efficacy
Timepoint
In the first, second and third months of follow-up
Method of measurement
Using standard questionnaire
2
Description
Assessing quality of life
Timepoint
In the first, second and third months of follow-up
Method of measurement
Using standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care and phone contact and training the patient for 5 to 10 minutes twice a week in the first month and then once a week in the second and third month
Category
N/A
2
Description
Control group: Just routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Hamadan City
Full name of responsible person
Soheila Shadi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
s.arshia@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Soheila Shadi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
00989180174844
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
s.arshia@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shamsizadeh
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mortezashamsizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available