Protocol summary

Summary
Objective: To determine the effect of group spiritual care on caregiving burden and quality of life in family caregivers of elders with Alzheimer's disease. Inclusion criteria include: moslem, minimum one year experience of care, personal statement on the role of primary caregiver for the elderly, without diagnose mental disorder. Study population include family caregivers of elders with Alzheimer's disease of Iran Alzheimer Association in 2014. Participants will 100 family caregivers who select from study population based on inclusion criteria and randomly allocate in three control and intervention groups. Interventions consist of five sessions of Spiritual training based on Richards and Bergin’s technique in five days. Each session continue for 45 to 60 minutes. Caregiving burden and quality of life measure before, after intervention. Rate of caregiving burden and quality of life compare before and after intervention in intervention and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111119898N1
Registration date: 2014-12-26, 1393/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-26, 1393/10/05
Registrant information
Name
Behrooz Mahdavi
Name of organization / entity
University of Social Welfare and Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
behroozmahdavi84@gmail.com
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group spiritual care on caregiving burden and quality of life in family caregivers of elders with Alzheimer's disease
Public title
The effect of spiritual care on caregiver burden and quality if life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Acceptance to be as a research participants; literacy to read and write in Persian; ability to talking with Persian language; moslem; minimum one year experience of care; personal statement on the role of primary caregiver for the elderly; Exclusion criteria: Absence of more than two sessions; if you are under the care of elderly people die during the study; caregivers who has medical background of depression or schizophrenia; caregivers who doesn’t complete their questionnaires
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran
City
tehran
Postal code
Approval date
2014-06-10, 1393/03/20
Ethics committee reference number
USWR.REC.1393165

Health conditions studied

1

Description of health condition studied
Alzheimer
ICD-10 code
G30.9
ICD-10 code description
Alzheimer disease, unspecified

Primary outcomes

1

Description
Caregiver Burden
Timepoint
Before intervention and five sessions after interventions
Method of measurement
Robinson Caregiver Strain Index

2

Description
Quality Of Life
Timepoint
Before intervention and five sessions after interventions
Method of measurement
Caregiver's QOL Scale

Secondary outcomes

1

Description
Age, Gender, Education, Economic situation
Timepoint
Befor intervention
Method of measurement
Demographic Questionnaire

Intervention groups

1

Description
Intervention group: The intervention will include of five sessions of spiritual-religious group therapy with emphasis on the Richards and Bergin’s spiritual therapy technique and based on Islamic Zikrs (holy Quran and Hadith with positive approach). Each session including 5-7 people and last from 45 min to one hour in average of five days.
Category
Behavior

2

Description
Control 1 group: This group without special intervention will participate in team meetings for 5 weeks, 45-60 minutes per session. Just to talk about everyday issues.
Category
N/A

3

Description
Control 2 group: Without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzheimer's Association of Iran
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr.Roshanak Vameghi
Street address
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran
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
Behrooz Mahdavi
Position
MSc student
Other areas of specialty/work
Street address
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran
City
tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
behroozmahdavi84@gmail.commahdavib67@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Masoud Fallahi khoshknab
Position
PhD
Other areas of specialty/work
Street address
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran
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
Behrooz Mahdavi
Position
MSc student
Other areas of specialty/work
Street address
Koodakyar Ave, Daneshjoo Blv, Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
00
Fax
Email
behroozmahdavi84@gmail.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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