Counseling and education of continuous self-care is one of controller factors of diabetes, as implementing this model have had positive effects on sleep quality of hemodialysis patients and chemical warfare victims with bronchiolitis obliterans. We decided to assess the effect of implementing continuous care model on sleep quality of patients with type 2 diabetes in Gonabad. Material and method: in this clinical trial 80 patients with type 2 diabetes who have sleep disturbances and other inclusion criteria will enter the study and randomly assigned to two intervention and control groups. The continuous care model will be implemented for the intervention group and the sleep quality will be assessed after 3 mounths later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202269140N1
Registration date:2012-04-11, 1391/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-11, 1391/01/23
Registrant information
Name
Somayyeh Golchin Rahni
Name of organization / entity
Gonabad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 1359
Email address
golchin.s@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Gonabad Univesity of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevalence of sleep disorder in type 2 Diabetics and effect of implementing continuous care model on sleep quality and disease control in 2012.
Public title
Prevalence of sleep disorder in type 2 Diabetics and effect of implementing continuous care model on sleep quality and disease control .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- patients with type 2 diabetes; 2- having sleep disorders; 3- having no acute complications and able to response to questionnaire; 4- having no psychological disease; 5- not taking sedatives; 6- having willingness to participate in the study; 7- having no known effective disease on sleep; 8- not having a neonate or any person which is needing frequent noctural wakes up; 9- not having any night shift; 10- not having a habbit of day sleeping; 11- not having frequent trips which effect on normal sleeping; 12- not pregnant; 13- ages between 50-70 years old; 14- have diploma up to BA degree. Exclusion criteria: 1- no willingness to continue the study, 2- researcher found the exchange of educated information between two intervention and control groups, 3- change in activity, dietary habits and medications.
Age
From 50 years old to 70 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad Univesity of Medical Sciences
Street address
Next to Asian Road, Gonabad Univesity of Medical Sciences
City
Gonabad
Postal code
9691793718
Approval date
2012-02-25, 1390/12/06
Ethics committee reference number
90/4/9/ک
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
e10-e14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Sleep quality
Timepoint
Before and 3 mounths after intervention
Method of measurement
Pitzburg Questionary
Secondary outcomes
1
Description
Blood glucose, Urea, Creatinine
Timepoint
Before and 3 mounths after intervention
Method of measurement
Pitzburg Questionary,Clinical tests
Intervention groups
1
Description
In control group: measuring blood glucose and urea and creatinine and at the end of intervention assessment for sleep quality.
Category
N/A
2
Description
In intervention group: measuring blood glucose and urea and creatinine and then implementing continuous care model for 6 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad Health Center
Full name of responsible person
Mrs Zohreh Ahrari
Street address
22 Bahman Hospital, Naser khosro Street
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Gonabad Univesity of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Next to Asian Road, Gonabad Univesity 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
Vice Chancellor for Research, Gonabad Univesity 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
Somayyeh Golchin Rahni
Position
Bsc. in Nursing- Msc. student in nursing
Other areas of specialty/work
Street address
No 4, Under Left, The first Two Floors Bulding, 23/1 Saadi Street, Gonabad, Khorasan-e-Razavi
City
Gonabad
Postal code
9691737958
Phone
+98 53 3722 1359
Fax
Email
somayyehgolchin@gmail.com
Web page address
www.gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad university of medical sciences
Full name of responsible person
Shahla Khosravan Doctor
Position
MD of Nursing
Other areas of specialty/work
Street address
Vice Chancellor for Research, Gonabad Univesity of Medical Sciences, Gonabad
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 0578
Fax
Email
mma_khosravan@yahoo.com
Web page address
www.gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad university of medical sciences
Full name of responsible person
Somayyeh Golchin Rahni
Position
MS student of MA nursing
Other areas of specialty/work
Street address
No 4, Under Left, The first Two Floors Bulding, 23/1 Saadi Street, Gonabad, Khorasan-e-Razavi
City
Gonabad
Postal code
9691793718
Phone
+98 53 3722 1359
Fax
Email
somayyehgolchin@gmail.com
Web page address
www.gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)