This study is a clinical trial which will be conducted aiming at the examining the impact of telenursing on diabetic foot patients treatment control. Inclusion criteria are accessing of patients to the cell phone, internet and social network software. Also the patients must provide informed consent. Pregnancy and participating in another ongoing intervention study are the exclusion criteria. In this study, the trial phase and blinding are not applicable. The sample size is 70 patients that randomly will be assigned to control and intervention groups. The patients in intervention group will receive health and medical orders via cell phones and smartphones after first visit in the wound clinic until their next visits while those in the control group will receive no intervention during the study. Eventually the impact of telenursing on controlling diabetic foot ulcer is being surveyed by two questionnaires: one is assessment of wound healing and other is telenursing impact on controlling diabetic foot ulcer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090229643N1
Registration date:2016-09-22, 1395/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Ghasem Deimazar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
gh.deimazar@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Science
Expected recruitment start date
2016-10-11, 1395/07/20
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey on telenursing impacts on treatment control of patients with diabetic foot ulcer
Public title
Telenursing impacts on treatment control of patients with diabetic foot ulcer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with diabetic foot ulcer; using phone cell; accessing to the internet; using social network software and signing informed consent.
Exclusion criteria: pregnancy and participating in another ongoing intervention study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethic committee of Semnan University of Medical Sciences
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.SEMUMS.REC.1395.90
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10.5
ICD-10 code description
Diabetes mellitus, with peripheral circulatory complications
Primary outcomes
1
Description
Diabetic foot ulcer
Timepoint
Since first visit until their next visits
Method of measurement
Wound healing assesment questionnaire
Secondary outcomes
1
Description
Telenursing impact
Timepoint
Since first visit until their next visits
Method of measurement
Telenursing impact on controlling diabetic foot ulcer questionnaire
Intervention groups
1
Description
The intervention group includes patients with diabetic foot ulcer who refer to a private wound clinic and will receive health and medical orders via cell phone until their last visit.
Category
Other
2
Description
The control group includes patients with diabetic foot ulcer who refer to a private wound clinic and will be followed with no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Marham Nusring center
Full name of responsible person
Shahrokh Khojaste far
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidi-Pour
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ghasem Deimazar
Position
Faculty member of Semnan University of medical Sciences
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
gh.deimazar@semums.ac.ir; gh.deimazar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ghasem Deimazar
Position
Faculty member of Semnan University of medical Sciences
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
gh.deimazar@semums.ac.ir; gh.deimazar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ghasem Deimazr
Position
MS of Medical Informatics
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
gh.deimazar@semums.ac.ir; gh.deimazar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)