Protocol summary

Summary
The effect of distant nursing using telephone counseling, on depression and anxiety of family caregivers for patients suffering from stroke in city of Sabzevar purpose of this study is to decrease depression and anxiety among the caregivers looking after the patients suffering from stroke.Inclusion criteria:Loss of cognitive disorders (dementia and delirium)Exclusion criteria : continue to withdraw from participation. The study population was 200 people selected from the caregivers who take care of the survived stroke patients above 60, discharged from hospital in Sabzevar city; of which 154 people were selected using purposive sampling method and were randomly placed in intervention and control groups. The intervention duration was three months. First, a primary home meeting is held for both groups to fill out “Beck depression and anxiety questionnaire” and how to communicate with the researcher and hereinafter distant nursing using telephone counseling will continue in the intervention group only. Calls are made in form of every other day ( during the first month) and two times a week (during the second and third month), and therefore a total of 32 telephone counseling calls are made by the nurse for the family plus calls made by the family for the nurse whenever necessary. Caregivers’ depression and anxiety will be assessed using a questionnaire after the intervention and 6 weeks after the end of the secondary intervention

General information

Acronym
Tele-nursing
IRCT registration information
IRCT registration number: IRCT2015080423493N1
Registration date: 2016-01-15, 1394/10/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Maryam Goudarzian
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
aging@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tele-nursing through telephone counseling practiceson depressionandanxiety in informalcaregivers ofstroke survivorsIn Sabzevar
Public title
The effect of telephone counseling on depression and anxiety in caregivers of patients with stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Loss of cognitive disorders (dementia and delirium)؛Physical ability to participate in the research؛Speaking in Farsi؛ Wherein hearing ability؛ No history of psychiatric hospitalization and psychiatric treatment؛ Lack of experience grief during the last 6 months؛ Consent to participate in research.Exclusion criteria : continue to withdraw from participation؛ psychotherapy sessions simultaneously lower score 8 out of 10 (lower score 7 to 9) Abbreviated Mental Test (AMTS)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
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
University of Social Welfare and Rehabilitation Sciences
Street address
Velenjak-kodakyar
City
Tehran
Postal code
Approval date
2015-10-18, 1394/07/26
Ethics committee reference number
IR.USWR.REC.1394.184

Health conditions studied

1

Description of health condition studied
Depression and anxiety
ICD-10 code
f32, f41.
ICD-10 code description
Generalized anxiety disorder,Depressive episode

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, intervention -Bd and 1/5 month after intervention
Method of measurement
Beck questionnaire

2

Description
Depression
Timepoint
Before the intervention, intervention -Bd and 1/5 month after intervention
Method of measurement
Beck questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First visit home In order to communicate and explain the family and how to advice, questions, how to access the consultant (researcher) in will be, will become. From nursing remotely by telephone only in the intervention group will continue on the basis of Jack and Associates 8195 Initial study sessions, every other day (the first month) and week 8 (the second and third months) and A total of 38 sessions will be conducted by telephone advice from nurses to family, but the family may at any time Need a nurse counselor's phone. During the conversation to the elimination of the need for careful consideration Have taken the time to make phone calls with the consent of the patients between 2 am and 2 pm is determined. And in Other hours may contact the emergency. After the intervention sessions and post-test data By Beck Depression Inventory and Beck Anxiety Inventory will be collected. And 3 weeks after intervention again Questionnaires for depression and anxiety in two groups will collect data on withdrawal times will be, will become
Category
Treatment - Other

2

Description
Control Groups : a meeting will be held to collect questionnaires Beck depression and anxiety
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Training Center of Health Mohammad Vasei
Full name of responsible person
Maryam Goudarzian
Street address
Sabzevar University of Medical Sciences, Vice Chancellor for Research Sabzevar- Khorasan Razavi- Iran
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr masoud fallahi khoshknab
Street address
Velenjak-kodakyar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Goudarzian
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
Tehran-Velenjak-Kodakyar
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
Aging@medsab.ac.ir mary_ac_ir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Dr masoud fallahi khoshknab
Position
Psychiatric Nursing Ph.D.
Other areas of specialty/work
Street address
Tehran-velenjak-kodakyar
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
Msflir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Goudarzian
Position
M.sc student of geriatric nursing
Other areas of specialty/work
Street address
Tehran-Velengak-Kodakyar
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
aging@medsab.ac.irmary_ac_ir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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