This is a randomized controlled clinical trial study to examine the effect of participation in support groups on the grief experience, quality of sleep and the fatigue of the family caregivers of people with Alzheimer's disease. The study population includes the family caregivers referring to the Alzheimer's Association. Eighty caregivers out of the population are selected based on the inclusion criteria, including having at least one year experience in patient care, having the least literacy and the absence of specified mental illnesses. If the caregiver wishes not to continue cooperation, the patient dies or participates less than three sessions in the support group, he or she will be excluded. During a meeting before the intervention starts, grief experience questionnaire, quality of sleep and fatigue will be filled in. Then eight sessions of one and a half to two hours a support group of two nurses, a psychologist, a doctor and a social worker will be formed. At the end of the eighth session and a month after that the relevant questionnaire will be filled in. Finally, the data are collected analyzed by SPSS 16 software and the results will be extracted and interpreted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410267212N2
Registration date:2015-06-22, 1394/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Elham Navab
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 1319
Email address
enavab@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, School of Nursing and Midwifery, Student
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participating in support groups on grief experience, quality of sleep and fatigue of family caregivers of persons with Alzheimer.
Public title
The effect of participating in support groups on grief experience, quality of sleep and fatigue .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All family caregivers of people with Alzheimer's, without considering the age requirement; having at least one year experience of caring for Alzheimer's patients; least literate; a willingness to participate in a support group; not having a marked mental illness.
Exclusion criteria:
Not wanting to continue working; death of the person with Alzheimer's; changing the primary caregiver of someone with Alzheimer's; participating in supportive groups; attending in less than three days of support groups meetings.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St., Islamic Enghelab St., Tehran
City
Tehran
Postal code
1417614411
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
93/د/130/1223
Health conditions studied
1
Description of health condition studied
Alzheimer
ICD-10 code
G30
ICD-10 code description
Alzheimer Disease
Primary outcomes
1
Description
Grief Experience
Timepoint
Before the intervention,The final session of intervention,One month after the intervention.
Method of measurement
MM Caregiver Grief Inventory - Short Form
2
Description
Quality of sleep
Timepoint
Before the intervention,The final session of intervention,One month after the intervention.
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
3
Description
fatigue
Timepoint
Before the intervention,The final session of intervention,One month after the intervention.
Method of measurement
Piper Fatigue Scale (PFS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Attending in support group, 8 sessions, one and a half to two hours once a week.
Category
Other
2
Description
Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Alzheimer's Association
Full name of responsible person
Samira Kianipour
Street address
Ekbatan, the mobilization, beginning nursing outlet north, next to the Municipal District 6 Zip code 1396853111
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
vice- chancellor for Research of Tehran University of Medical Science
Street address
Sixth Floor, Centeral Organization Of Univercity,At the corner of Qods Street , Keshavarz Boulevard,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Tehran University of Medical Sciences, School of N ursing and Midwifery