The effect of tele-nursing on the outcome of care by caregivers of patients with head trauma after discharge from hospital This study is conducted on home caregivers of patients with head trauma. Using convenient sampling method, a sample size of 72 patients is selected from among patients presenting with head trauma for the first time, who are then placed in intervention and control groups (36 patients in each) using random block method. Intervention is conducted on patients' family in the form of telephone follow-up and outcomes (readmission or incidence of pressure wounds) on patients are assessed. Data are collected using a checklist comprising "patient's condition" and "outcome of care" sections. Validity and reliability of the checklist are confirmed using content validity and internal consistency with Cronbach's alpha, respectively. A day before patient's discharge, all caregivers (in both intervention and control groups) are trained on how to perform patient care at home, and a booklet is also given to them. The questioner phones caregivers in the intervention group once a week for 12 weeks and collects data on patient’s condition.Caregivers in this group are also able to contact the questioner at any time they require further information about the patient.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014110919868N1
Registration date:2015-12-04, 1394/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-04, 1394/09/13
Registrant information
Name
Atousa Amouzegar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 9303
Email address
a.amouzegar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental, vice chancellor for research of Qazvin University of Medical Sciences.
Expected recruitment start date
2015-05-10, 1394/02/20
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele-nursing on the outcome of care by caregivers of patients with head trauma after discharge from hospital
Public title
The effect of tele-nursing on head trauma patients' situation
Purpose
Supportive
Inclusion/Exclusion criteria
Study inclusion criteria for patients include age range 18-60 years, level of consciousness 11 to 15 based on Glasgow Coma Scale, admission for the first time following head trauma, with no known urinary or respiratory infections and no infectious pressure wounds, no grade 3 or 4 pressure wound,no diagnosed with known diabetes, no tracheostomy, and no PEG. Study inclusion criteria for caregivers are having minimum literacy (reading and writing), Family member who is responsible for the care and at least half of the time of day to take care of patient, availability on the phone (landline or mobile), no speech or hearing impairments, non-employment in healthcare professions, and willingness to take part. Study exclusion criteria is use of caregivers from nursing homes
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients would be allocated to study and control by balanced block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin university of medical sciences
Street address
Nursing & Midwifery School, Qazvin university of medical sciences, Bouvl. Shahid Bahonar, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
D/20/9376
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
VI
ICD-10 code description
Other specified disorders of brain in diseases classified elsewhere
Primary outcomes
1
Description
readmission
Timepoint
For study group telephone follow up every week during 12 weeks period of time, and for controls just telephone contact after 12 weeks.
Method of measurement
Questionnaire
2
Description
pressure wound incidence
Timepoint
For study group telephone follow up every week during 12 weeks period of time, and for controls just telephone contact after 12 weeks.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Caregivers' viewpoints about telenursing
Timepoint
after 12 weeks telephone follow
Method of measurement
Questionnaire
Intervention groups
1
Description
Telephone follow up (via landline or mobile) of patients' condition in 12 weeks period of time through contact with family caregivers once a week
Category
Other
2
Description
Control: During patient discharge and after 12 weeks ,control patients are assessed in terms of readmission and pressure wound incidence.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Atousa Amouzegar
Street address
Hasan Abad Sq, Emam Khomeini St, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Atousa Amouzegar
Street address
End of Boul. Keshavarz, Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Atousa Amouzegar
Street address
Three-way Jalal Ahmad, North Kargar St, Tehran
City
Tehran
4
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Atousa Amouzegar
Street address
Behdari St. Rah ahan Sq, Tehran
City
Tehran
5
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Atousa Amouzegar
Street address
Region 17, municipality, Abuzar Street, Crossroads ghapan, Qazvin Street, Tehran
City
Tehran
6
Recruitment center
Name of recruitment center
Shohada-E-Tajrish hospital
Full name of responsible person
Atousa Amouzegar
Street address
Btween Tajrish Sq and Quds Sq, Shahrdari St, Tajrish Sq, Tehran
City
Tehran
7
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Atousa Amouzegar
Street address
shahid madani St, Emam Hossein Sq, Tehran
City
Tehran
8
Recruitment center
Name of recruitment center
Hazrat-E- Rasool Akram Hospital
Full name of responsible person
Atousa Amouzegar
Street address
Nyayesh street, Satarkhan street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Fatemeh Mohamadi
Street address
Nursing & Midwifery School,Qazvin university of medical sciences, Blvd Bahonar, Qazvin
City
Qazvin
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 of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Atousa Amouzegar
Position
Nursing master degree student
Other areas of specialty/work
Street address
App. 2, N. 52, Golestan 7, Nahid street, Blvd. Marzdaran, Tehran
City
Tehran
Postal code
1461664844
Phone
+98 21 4424 3502
Fax
+98 28 3323 7268
Email
atousa.amouzgar@gmail.com
Web page address
www.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of medical sciences
Full name of responsible person
Akram Shahrokhi
Position
MSc. Faculty member
Other areas of specialty/work
Street address
Room 236, Nursing&Midwifery school,Qazvin University of Medical Sciences, Bahonar Blvd
City
Qazvin
Postal code
3419759811
Phone
+98 28 3333 9569
Fax
+98 28 3323 7268
Email
a.shahrokhi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Atousa Amouzegar
Position
Master degree student,Critical Care Nursing
Other areas of specialty/work
Street address
App. 2, N. 52, Golestan 7, Nahid street, Blvd. Marzdaran, Tehran
City
Tehran
Postal code
1461664844
Phone
+98 21 4424 3502
Fax
Email
atousa.amouzgar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)