History
# Registration date Revision Id
2 2019-09-27, 1398/07/05 116228
1 2017-02-26, 1395/12/08 22882
Changes made to previous revision
This is the first revision

Protocol summary

Summary
This study is an interventional study with a control group. The sample size was estimated 25 for each group ( totally 50), according to comparison two mean formula based on previous studies.To select samples, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016052828121N1
Registration date: 2017-02-26, 1395/12/08
Registration timing: retrospective

Last update:
Update count: 1
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Simin Salehi Nejad
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5418
Email address
s_salehi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kerman University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surveying the effect of a Web-based Health information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia in Kerman and evaluation of their satisfaction
Public title
Effect of information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in research; caregiver is personally responsible for patient care (the care of his responsibility); internet access (at least twice a week); understanding and ability to work with Internet; interested in receiving information on this disease. Exclusion criteria: unwillingness to continue to cooperate; escrow patient care to other people; patient death.
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Somayeh intersection, In front of the Besaat clinic,
City
Kerman
Postal code
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
IR.KMU.REC.1395.185

Health conditions studied

1

Description of health condition studied
Dementia in Alzheimer disease
ICD-10 code
F00
ICD-10 code description
Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years

2

Description of health condition studied
Vascular dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia is the result of infarction of the brain due to vascular disease, including hypertensive cerebrovascular disease. The infarcts are usually small but cumulative in their effect. Onset is usually in later life

3

Description of health condition studied
Dementia in other diseases classified elsewhere
ICD-10 code
F02
ICD-10 code description
Cases of dementia due, or presumed to be due, to causes other than Alzheimer disease or cerebrovascular disease. Onset may be at any time in life, though rarely in old age

Primary outcomes

1

Description
Care burden
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire

2

Description
Care performance
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire

3

Description
Knowledge
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire

4

Description
Attitude
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care will be present during 2 months (12 sessions) and in forms of text, slides, pictures and video all information which approved by a neurologist.
Category
Other

2

Description
The participants of control group received no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurologists office
Full name of responsible person
Neurology Specialist
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman, University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Somayeh intersection, In front of the Besaat clinic
City
Kerman
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, Kerman, University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Medical Informatics Resaerch Center
Full name of responsible person
Dr. Reza Khajouei
Street address
Unit 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Informatics Resaerch Center
Proportion provided by this source
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
Kerman Medical Informatics Resaerch Center
Full name of responsible person
Simin Salehi Nejad
Position
MS.c
Other areas of specialty/work
Street address
No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
City
Kerman
Postal code
Iran
Phone
+98 34 3132 5418
Fax
Email
s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman Faculty of Management and Health Informatics
Full name of responsible person
Mohammad Aazami
Position
Ph.D of library and information sciences
Other areas of specialty/work
Street address
Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
City
Kerman
Postal code
Iran
Phone
+98 34 3132 5394
Fax
Email
mohammadaazami14@gmail.com; m_azami@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman Medical Informatics Resaerch Center
Full name of responsible person
Simin Salehi Nejad
Position
MS.c
Other areas of specialty/work
Street address
No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
City
Kerman
Postal code
Iran
Phone
+98 34 3132 5418
Fax
Email
s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir
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
Loading...