Protocol summary

Summary
Aim: The effect of resilience training on mental health of family caregiver of elderly with Alzheimer. The study population: family caregivers of elderly with Alzheimer who live in the Ghaemshahr city. Study design: randomized clinical trial. Sample size: totally 50 patients (25 patients in each group) were participated. The individuals were selected based on the inclusion and exclusion criteria and randomly assigned into two intervention and control groups. Mental health questionnaire was filled out for patients by researcher in both groups, before and after intervention. In this study, resilience training was delivered to the participants through 45-minute educational sessions and pamphlet. These sessions were held once a week for 8 weeks in Razi hospital. The control group received no intervention. After the training program (40 to 45 days later) mental health questionnaire was filled out again for participants in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080829251N1
Registration date: 2017-02-11, 1395/11/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Mehdi Rostami Ghadi
Name of organization / entity
Azahra Faculty of Medical Nursing, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 5151
Email address
m.rostami@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resilience training on the mental health of family caregiver of elderly with alzheimer
Public title
The effect of resilience training on mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Resilience score is less than 50, but The other does not take care to elderly with Alzheimer's، Carers aged at least 30 and a maximum of 55 years، Full care in three areas of financial, emotional and physical done Having the ability to answer the questions. Exclusion criteria: unwillingness to cooperate and Not participating in In two sessions of training sessions.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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 Babol University of Medical Sciences
Street address
Ganjafrooz street، Babol
City
Babol
Postal code
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
IR.MUBABOL.REC.1395.48

Health conditions studied

1

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

Primary outcomes

1

Description
Resilience
Timepoint
Before and 40 days after intervention
Method of measurement
Resilience questionnaire

Secondary outcomes

1

Description
Mental health
Timepoint
Before and 40 days after intervention
Method of measurement
Mental health questionnaire

Intervention groups

1

Description
Intervention group: Resilience training was delivered to the participants through educational sessions and pamphlet. These sessions were held once a week for 8 weeks.
Category
Behavior

2

Description
Control group: individuals in this group didn't receive any intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital and doctors neurologists' offices in Ghaemshahr
Full name of responsible person
Mehdi Rostami
Street address
Bahonar Alley, Juibar street Ghaemshahr
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Mehdi Rostami
Street address
Ganjafrooz Street، Babol
City
Sari
Grant name
Grant code / Reference number
9542031
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rostami
Position
Master Student in Geriatric Nursing
Other areas of specialty/work
Street address
Nursing and medwify alzahra School Ramsar
City
Sari
Postal code
4691714141
Phone
+98 11 3219 9592
Fax
Email
mehdirostami1049@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing Ramsar, Babol University of Medical Sciences
Full name of responsible person
Zahra Fotoukian
Position
Ph.D.in Nursing
Other areas of specialty/work
Street address
Nursing and midwify alzahra school in ramsar
City
Ramsar
Postal code
4691714141
Phone
+98 11 3219 9592
Fax
Email
z.fotoukian@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rostami
Position
Master Student in Geriatric Nursing
Other areas of specialty/work
Street address
Nursing and midwify Alzahra school in nursing Ramsar
City
Sari
Postal code
4691714141
Phone
+98 11 3219 9592
Fax
Email
mehdirostami1049@yahoo.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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