Evaluation the effect of participating in support groups on the depression, loneliness and quality of life of family caregivers of Alzheimer’s persons.
The aim of this study is evaluation the effect of participation in the support groups on the depression, loneliness and quality of life of family caregivers of Alzheimer’s persons referring to Iran Alzheimer
Association.
Design: Randomization, with control group, Before and after 0f intervention.
Inclusion criteria:
All family caregivers of Alzheimer’s persons, without considering the age range.
Having at least one year of experience caring of Alzheimer’s person.
Having at least literacy of Reading and writing.
Having a desire to participate in a support group.
Lack of identified mental illness.
Exclusion criteria:
Lack of desire for maintaining participation.
Death of Alzheimer’s person.
Change of the primary caregiver of Alzheimer’s person.
Participation in support groups.
Participating in less than three sessions of support groups.
Sample size: 80.
Intervention: support group.
length of the intervention: 8 session within eight weeks and every session takes 1.5-2 hours.
Primery outcome:
Depression,
loneliness,
quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108037212N1
Registration date:2012-04-17, 1391/01/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-17, 1391/01/29
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, Vice chancellor for Research
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of participating in support groups on the depression, loneliness and quality of life of family caregivers of Alzheimer’s persons.
Public title
The effect of participating in support groups on the depression, loneliness and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All family caregivers of Alzheimer’s persons, without considering the age range.
Having at least one year of experience caring of Alzheimer’s person.
Having at least literacy of Reading and writing.
Having a desire to participate in a support group.
Lack of identified mental illness.
Exclusion criteria:
Lack of desire for maintaining participation.
Death of Alzheimer’s person.
Change of the primary caregiver of Alzheimer’s person.
Participation in support groups.
Participating in less than three sessions of support groups
Age
From 18 years old to 90 years old
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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Quods St., Keshavarz Av.
City
Tehran
Postal code
Approval date
2014-08-23, 1393/06/01
Ethics committee reference number
1222
Health conditions studied
1
Description of health condition studied
Quality of Life
ICD-10 code
G30
ICD-10 code description
Alzheimer disease
Primary outcomes
1
Description
Depression
Timepoint
before intervention and one month after intervention
Method of measurement
Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
2
Description
Loneliness
Timepoint
before intervention and one month after intervention
Method of measurement
short form of the social and emotional loneliness scale for adults (SELSA-S),
3
Description
Quality of life
Timepoint
before intervention and one month after intervention
Method of measurement
SF- 36 standard questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Eight sessions of support group will be held for every participant. Every session would be 1/5-2 hours in length and the researcher will attend all sessions as a nurse.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Alzheimer Association,Iran
Full name of responsible person
Elham Navab
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, PO Box: 14155-6446, Tehran, Iran
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 Sciences, Vice chancellor for research
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
Full name of responsible person
Elham Navab
Position
PhD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery ,Nosrat St., Tohid Sq.,Tehran
City
Tehran
Postal code
Phone
+98 21 2610 1319
Fax
Email
enavab@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Elham Navab
Position
PhD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Nosrat St., Tohid Sq.,Tehran
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
enavab@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Eham Navab
Position
PhD of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 2610 1319
Fax
Email
enavab@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)