Protocol summary

Summary
The aim of the study: Evaluate the impact on the burden of caring multi-group family therapy in caregivers of patients with Alzheimer's disease referred to specialty and subspecialty Clinic of Imam Reza City Shiraz was in 1395; Study design: Randomized to the control group; Before and after the intervention and is one month after the intervention; Inclusion criteria: At least 12 months experience caring for elderly family member with Alzheimer's disease; Having at least literacy of Reading and writing; Willing to participate and continue to plan; Exclusion criteria: Feel free to leave group; In the absence of more than two sessions of family therapy; The risk of mental illness, mood disorders and chronic cognitive carers; History of participation in groups and intervention programs and family education about caring for the elderly; Sample size: 110 families; Psychological interventions in the form of 8 sessions of 90-minute classes will run the way of family therapy; A standard questionnaire to determine barmraqbty caregivers Zarit Burden Interview is used to measure the burden of care; we can measure the effect of multiple family group therapy on burden of Alzheimer's family caregivers and if it was effective on burden of caregivers, the education can be used for reducing caregiver's burden.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016083129620N1
Registration date: 2017-03-26, 1396/01/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-26, 1396/01/06
Registrant information
Name
Nazanin Naderi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3730 1263
Email address
nazaninnaderioriginal@gmail.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multiple family group therapy on burden of Alzheimer patient's caregivers in the city of shiraz in 1395.
Public title
The effect of multiple family group therapy on burden of Alzheimer patient's caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least 12 months experience caring for elderly family member with Alzheimer's disease; Having at least literacy of Reading and writing; Willing to participate and continue to plan; Exclusion criteria: Feel free to leave group; In the absence of more than two sessions of family therapy; The risk of mental illness, mood disorders and chronic cognitive carers; History of participation in groups and intervention programs and family education about caring for the elderly
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: 110
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
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Postal code
1433671348
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
ir.sums.rec.1395.65

Health conditions studied

1

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

Primary outcomes

1

Description
The burden of caring
Timepoint
Before intervention; Immediately after intervention and one month after intervention
Method of measurement
Zarit inventory burden of care

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing multiple family group therapy intervention; The educational intervention content and educational planning will be designed based on pre-test results of the two groups
Category
Lifestyle

2

Description
Control group: In control group, there will be no interventions. The burden questionnaire will be answered by the participants in this group and 8 weeks after training finished in intervention group, and 1 month after intervention, burden will be measured by the questionnaire again.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Imam Reza
Full name of responsible person
Dr. Peiman Petramfar
Street address
Specialized clinic of Imam Reza, Square Namazi, Shiraz specialized clinic of Imam Reza
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR. Roxana Jan Ghorban
Street address
Faculty of Nursing and Midwifery, Square Namazi, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yekta Talab
Position
PhD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Square Namazi, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
shahrzadyekta@yahoo.com
Web page address
nurs-midwif.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yekta Talab
Position
PhD in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Square Namazi, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
shahrzadyekta@yahoo.com
Web page address
nurs-midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Nazanin Naderi
Position
MSc Nursing Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Square Namazi, Shiraz
City
Shiraz
Postal code
1311971936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
Nazaninnaderioriginal@gmail.com
Web page address
nurs-midwif.sums.ac.ir

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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