Protocol summary

Summary
This study is a randomized clinical trial .the aim of this study was to determin the effect of problem oriented coping strategies education on quality of life and perceived stress of family care givers of elderly with Alzheimer in city of kerman. Research community consist of family care givers of elderly with Alzheimer that refer to the public hospital. .sample size According to previous studies and statistical formulas were 36 person in each group. Participants were randomly assigned to an control group and intervention group. Before intervention , Demographic questionnaire , Quality of Life Questionnaire sf 36 and Cohen Perceived Stress Questionnaire Were completed by caregivers. In intervention group: Eight 45-minute sessions one day a week teaching problem solving and In control group :Two sessions of training in relation to Alzheimer's disease were conducted . Two weeks after intervention, information about the quality of life and perceived stress were re-collect and analyze

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050327736N1
Registration date: 2016-08-10, 1395/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-10, 1395/05/20
Registrant information
Name
shahin heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5351
Email address
sh.heidari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of problem oriented coping strategies education on quality of life and perceived stress of family care givers of elderly with Alzheimer
Public title
Impact on quality of life and perceived stress problem solving skills
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being a member of the family؛ taking care of patients at home ؛have at least read and writing؛ patient care for a year or more؛ without having cognitive disease and No previous training in the ways of coping exclusion criteria: Alzheimer's patient dies؛ non-cooperation and careful happening severe stressful event such as a divorce or the death of loved ones ... in the last three months
Age
No age limit
Gender
Both
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
175

Health conditions studied

1

Description of health condition studied
Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer disease

Primary outcomes

1

Description
quality of life
Timepoint
two week
Method of measurement
Questionnaire

2

Description
perceived stress
Timepoint
two week
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group: Eight 45-minute sessions one day a week teaching problem solving disease
Category
Lifestyle

2

Description
In control group :Two45-minute sessions of training in relation to Alzheimer's
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Maryam Heydari Nejad
Street address
Afzalipour hospital, Highway Imam Khomeini, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebe Mirzaei
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Maryam Heydari Nejad
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3273 9856
Fax
Email
Maryam.heydari6693@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahin Hrydari
Position
Master of nursing
Other areas of specialty/work
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3325 5900
Fax
Email
Kermanshah3252@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Maryam Heydari Nejad
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Postal code
Phone
Fax
Email
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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