Due to the meaningful increase in the elderly population in Iran and the high spread of stroke in the elderly and its complicationsand incidence of care burden in caregivers on elderly with stroke, in this regard a study was designed to investigate the effect of tele- nursing on the care burden of caregivers of elderly stroke patient.
Design
The present study is a randomized clinical trial study on caregivers of stroke patients that will be conducted after getting permission .
Settings and conduct
First, elderly 60 years and older patients with a diagnosis of stroke that were hospitalized in the neurology department of Bu-Ali hospital during 1 to 6 past months were extracted and if they have inclusion criteria and fixed caregiver they will be contracted and will enter the study after obtaining the consent letter. Then, participants will be randomly divided into intervention and control groups using a 4-block randomized method.
Participants/Inclusion and exclusion criteria
Study entry for study:
Having the consent
having direct resposibility for the care of the elderly patient
Having a family relationship with the patient
Having a mobile phone
Resident of Qazvin
having a minimum primary education
minimum age 18 years and older
non payment for care
Exclusion criteria for caregivers:
enabling to communicate
simultaneous care of both stroke and non-stroke patients.
Unwillingness to cooperate or disconnect the phone connection
the use of nursing service offices
Mental illness diagnosed
Intervention groups
A training booklet will be provided to both intervention and control groups, then training will be provded during tele-nursing according to the patients problem to the intervention group during phone connection and through social networks. Questionnaires before and after will be filled out in both groups.
Investigation of the Effect of Tele-nursing on Care Burden in Caregivers of Elderly Patients with Stroke
Public title
Tele-nursing and Care Burden in Caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the consent to participate in the study
having direct resposibility for the care of the elderly patient at least 8 hours a day
Having a family relationship with the patient, including the spouse, child, brother, sister that living with the patient.
Having a mobile phone with the capability to install soroush app
Resident of Qazvin
having a minimum primary education
minimum age 18 years and older
non payment for care
Exclusion criteria:
enabling to communicate
simultaneous care of both stroke and non-stroke patients
Unwillingness to cooperate or disconnect the phone connection for two weeks in the first months of intervention(experiment) and for three weeks in the second and third months of intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, the sampling method will be purposeful and accessible. participants will be randomly divided into intervention and control groups using a 4-block randomized method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Given that both groups have got primary education at discharge time, a training booklet will be provided for the intervention and control groups. Also, considering the patients problem, after the needs assessment, training in tele-nursing time will be done in the first contact with the caregiver, then in the intervention group the training will be provided during phone connection through social network.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.QUMS.REC.1399.037
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
The care burden questionnaire was made by zarit etal. to measure care burden. the questionnaire includes 22 questions about personal,social,emotional and economic burdens that will be completed by the researcher through interviews with family caregivers. in this tool,based on the questions the care burden in caregivers is divided into two objective and mental groups.
Timepoint
Measurement of care burden before and 12 weeks after intervention
Method of measurement
Zarit Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:caregivers of elderly stroke patients(above 60 years old) are firstly selected with a diagnosis of stroke then if they have inclusion criteria and consrnt letter, they will participate in the study.An educational booklet will be given to intervention groups and questionnaire will be completed first. Then, training during tele- nursing due to the patients problem after the needs assessment, which will be done in the first contact with the care giver in the intervention group through 12 weeks phone connection and social network. The questionnaire will be filled out again after 12 weeks.
Category
Lifestyle
2
Description
Control group:caregivers of elderly stroke patients(above 60 years old) are firstly selected with a diagnosis of stroke then if they have inclusion criteria and consent letter, they will participate in the study.An educational booklet will be given to intervention groups and questionnaire will be completed first.The questionnaire will be filled out again after 12 weeks without any intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Hoda Baniardalan
Street address
Booali Hospital; Street Booali; Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Hoda.ar485@gmail .com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mahdi Emamjome
Street address
Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 8034
Email
hoda.ar485@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hoda Baniardalan
Position
Master student of eldrly nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Qazvin, University of Medical Sciences,Shahid Bahonar Boulevard,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Hoda.ar485@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Faculty of Nursing and Midwifery,Qazvin,University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419799811
Phone
+98 28 3333 6001
Email
mohammadi1508@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
hoda bani ardalan
Position
Master student of elderly nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery,Qazvin University of Medical Sciences, Shahid Bahonar, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3365 1735
Email
hoda.ar485@gmail.com
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