The empowerment and support of family caregivers is important; so the aim of this study is to investigate the effect of information support on anxiety and quality of life of family caregivers with dementia elderly.
In this quasi-experimental and interventional two-grouped and three-stage study, 70 family caregivers with dementia elderly ask to participate through a call in neurologic and psychologic clinics affiliated to Shiraz University of Medical Sciences. Caregivers should be above 18 years old, experience in patient care for at least three consecutive months, and access to the mobile and social networks. They should also get average score of anxiety caregivers obtained from Spielberger questionnaire more than 31; and the score of quality of life obtained from Thomas quality of life questionnaire less than 80. Referring the elderly to long-term care centers, the occurrence of a crisis events or severe stress such as the death of loved ones and divorce for the caregiver during the study; and the caregiver’s attendance in training sessions on the care of the elderly with dementia over the past 6 months leads to caregiver’s exclusion from the study. The caregivers divide into two experimental (35 people) and control (35 people) groups by random block allocation. The experimental group receive information support in two distinct parts including training (elderly with dementia care and self-care in seven 90-minute training sessions) and information-counseling support (by phone, SMS, video call with virtual messenger programs or email for 4 weeks, 3 hours a day). Blinding is not done in this study.
The control group receive no information support during the study.
In this study, family caregiver’s anxiety and quality of life measure, compare and evaluate in three stages: pre-study, immediately after the last counseling session and three months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080915426N4
Registration date:2017-10-03, 1396/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Maryam Hazrati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 3949
Email address
hazratim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of informational support on anxiety and quality of life in family caregivers of elders with dementia
Public title
Effects of informational support on elder family caregivers
Purpose
Supportive
Inclusion/Exclusion criteria
• Inclusion criteria: The caregiver’s willingness to participate in the research and to complete the self-consent form; taking the main responsibilities towards the patient; having the caregiver’s reading and writing skills; being the caregiver’s age above than 18 years old; the caregiver’s access to phone, mobile, and social networks; experience in patient care for at least three consecutive months; having at least six months to five years dementia disease history; getting average score of anxiety caregivers obtained from Spielberger questionnaire more than 31; and the score of quality of life obtained from Thomas caregiver quality of life questionnaire less than 80.
• Exclusion criteria:
The caregiver physical and mental illnesses during the study; taking liquors or psychotropic drugs by the caregiver; referring the patient to long-term care centers during the study; the occurrence of a crisis events or severe stress such as the death of loved ones and divorce for the caregiver during the study; the caregiver’s attendance in training sessions on the care of the elderly with dementia over the past 6 months; the elderly’s suffering from other disabling diseases such as heart failure, asthma or uncontrolled diabetes before or during the study; the caregiver’s responsibility of taking care of someone else in the family.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
71348-14336
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.SUMS.REC.1396.76
Health conditions studied
1
Description of health condition studied
Dementia in Alzheimer disease
ICD-10 code
G30.1
ICD-10 code description
Alzheimer disease with late onset
2
Description of health condition studied
Vascular dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia
3
Description of health condition studied
Dementia in other diseases
ICD-10 code
F02
ICD-10 code description
Dementia in other diseases classified elsewhere
Primary outcomes
1
Description
Anxiety
Timepoint
Before, exactly and 3 months after intervention
Method of measurement
Spielberger questionnaire
2
Description
Quality Of life
Timepoint
Before, exactly and 3 months after intervention
Method of measurement
Thomas caregivers quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The case group receive informative support in two distinct parts, including: in-person training (caring elder with dementia and self-care; in seven 90-minute training sessions) and Informative-counseling support: (by phone, SMS, video call with virtual messenger programs or email for 4 weeks, 3 hours a day). Also a book that approved by university professors give to the caregivers.
Category
Other
2
Description
The control group received no informative support during the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Ganj Karimi
Street address
Namazi square
City
Shiraz
2
Recruitment center
Name of recruitment center
Ebn Sina hospital
Full name of responsible person
Shojaee Ali
Street address
Hafez street
City
Shiraz
3
Recruitment center
Name of recruitment center
Professor Moharrery psychological hospital
Full name of responsible person
Homayoonfar Farzad
Street address
Next to Shiraz agriculture college
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Hashemi Seyed Basir
Street address
Zand street
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
Dr. Maryam Hazrati
Position
Assistant professor
Other areas of specialty/work
Street address
Namazi square
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
hazratim@sums.ac.ir
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
Dr Hazrati Maryam
Position
Assistant professor
Other areas of specialty/work
Street address
Namazi square
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
hazratim@sums.ac.ir
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
Zarepour Abdorahman
Position
student of post graduate in geriatric nursing
Other areas of specialty/work
Street address
Namazi square
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
abd.zarepour@gmail.com
Web page address
www.igncare.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)