Protocol summary
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Study aim
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This study aim is evaluating the efficacy of a Web-based health information program for informal caregivers of patients with dementia through a pilot unblinded randomized controlled trial
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Design
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randomised trial with control group, unblinded intervention and outcome assessment
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Settings and conduct
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for selecting participants, 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.
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Participants/Inclusion and exclusion criteria
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inclusion criteria; personally responsible for patient care (the care was his/her responsibility); to have access to a computer with Internet connection, ability to work with Internet
exclusion criteria: continue participation, assign patient care to other people were our exclusion criteria, and patients death.
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Intervention groups
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We recruit and randomize 50 informal caregivers of patients with dementia in Kerman, Iran. They either receive the Web-based intervention and usual care for 2 months (experimental group, n=25) or only usual care (control group, n=25). Caregivers’ perceived knowledge, care burden, attitude and care function were measure at baseline and at the end of the program
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Main outcome variables
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knowledge
care burden
attitude
care function
General information
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Reason for update
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this trial updating because:
1- update the sampling date: The sampling took longer than originally mentioned due to the drop in the number of samples before starting the intervention. because most of them canceled their cooperation.
2- double blinded changed to un blinded because double blinded did not apply in web interevention.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016052828121N1
Registration date:
2017-02-26, 1395/12/08
Registration timing:
registered_while_recruiting
Last update:
2019-12-31, 1398/10/10
Update count:
1
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Registration date
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2017-02-26, 1395/12/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research, Kerman University of Medical Sciences
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Expected recruitment start date
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2016-11-21, 1395/09/01
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Expected recruitment end date
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2017-05-22, 1396/03/01
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Actual recruitment start date
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2016-11-21, 1395/09/01
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Actual recruitment end date
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2017-05-22, 1396/03/01
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Trial completion date
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2017-11-11, 1396/08/20
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Scientific title
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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
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Public title
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Effect of information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
nclusion 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.
Exclusion criteria:
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Age
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From 15 years old to 90 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the Stratified randomization method was used. By attempting to eliminate heterogeneity of the groups before random allocation by classifying two variables; age and the number of hours in day caring for care recipient
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-08-20, 1395/05/30
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Ethics committee reference number
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IR.KMU.REC.1395.185
Health conditions studied
1
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Description of health condition studied
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Dementia in Alzheimer disease
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ICD-10 code
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F00
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ICD-10 code description
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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
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Description of health condition studied
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Vascular dementia
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ICD-10 code
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F01
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ICD-10 code description
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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
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Description of health condition studied
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Dementia in other diseases classified elsewhere
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ICD-10 code
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F02
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ICD-10 code description
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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
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Description
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Care burden
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Timepoint
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At the begining and 2 months after intervention
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Method of measurement
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Questionnaire
2
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Description
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Care performance
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Timepoint
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At the begining and 2 months after intervention
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Method of measurement
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Questionnaire
3
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Description
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Knowledge
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Timepoint
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At the begining and 2 months after intervention
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Method of measurement
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Questionnaire
4
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Description
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Attitude
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Timepoint
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At the begining and 2 months after intervention
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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The participants of control group received no intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research, Kerman, University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Medical Informatics Resaerch Center
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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the primary outcome measure only
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When the data will become available and for how long
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starting results 6 months after publication
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To whom data/document is available
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Patient and caregiver data will not be available for anybody
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Under which criteria data/document could be used
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Only use the results of the study in future studies
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From where data/document is obtainable
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email: s_salehi@kmu.ac.ir
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What processes are involved for a request to access data/document
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Undecided
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Comments
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