Protocol summary

Summary
The purpose of this study is to enhance the independence and communication skills among elder people through educating of their families. Inclusion criteria: the elderly people should be physically active and have the ability to do their daily works without depending on others and they should be able to participate in the study. Exclusion criteria: death during the study, being absence for more than one session in educational sessions, physical illnesses with the instability conditions (stroke and heart attack, leading to paralysis and Parkinson's, Alzheimer's), Chronic diseases such as uncontrolled diabetes, and severe birth defects and limiting skeletal disorders, Having uncontrolled mental illness, family members' unwillingness to participate in the study are excluded of this study. Sixty elder people, aged 60 years or older, and their families who are eligible for this study are selected This study is conducted as a pre test-post tests, two-group, interventionl study. After filling out the informed consent form, seniors and their families are divided into intervention and control groups. Loyola Generativity Scale will be filled out by seniors. The intervention group (families of the elder people) receive seven group-training sessions (two 30-40 minute sessions per week) on these topics: elder people and mental changes, the role of family relationships in the health of the elderly, the principles associated with the elderly, social interactions and support systems, communication skills and ways to improve them, communication barriers in the elderly and dealing with it . After finishing the study, post-test will be done for families and seniors and post test will be done after one month. Generativity and communication skills will be measured among elder people based on educating of their families

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016041627414N1
Registration date: 2016-06-16, 1395/03/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Sara Rahmanian Koshkaki
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stud1817297376@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of holding communication skill training course to seniors family on seniors creativity:a clinical trial
Public title
The effect of communication skills training to raise the creators of seniors family
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Adults over 60 years old, be physically active and have the ability to do daily tasks without dependence on others . Exclusion criteria : death of samples during the study , being absence for more than one session in educational sessions , physical illnesses with the instability conditions (stroke and heart attack, leading to paralysis and Parkinson's, Alzheimer's) , Chronic diseases such as uncontrolled diabetes, and severe birth defects and limiting skeletal disorders , Having uncontrolled mental illness, family members' unwillingness to participate in the study.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University oF Medical Science
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.SUMS.REC.1395.12

Health conditions studied

1

Description of health condition studied
Generativity in older adults
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Generativity
Timepoint
one month after intervention
Method of measurement
Loyola questionnair

Secondary outcomes

1

Description
Family Relationship
Timepoint
two sessions a week for 30 to 40 minutes)Till 4 Week
Method of measurement
Loyola questionnaire

Intervention groups

1

Description
Control group: At first fill out a questionnaire by the elderly and after one month, the researchers examine them again. They will left without any education.
Category
Behavior

2

Description
Intervention Groups: filled out The questionnaires Loyola by elderly population .This study involved two groups of pre test – post test. in the study elderly and their families are selected randomly and after Pre-test and control groups and tested during the 7 sessions A team (two sessions a week for 30 - 40 minutes)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sorosh aging daily center in shiraz
Full name of responsible person
Ladan Zarshenas
Street address
Tachara street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University Of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Street address
Zand Street, Shiraz .
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
School of Nursing And Midwifery, Shiraz University Of Medical Sciencec
Full name of responsible person
Zarshenas Ladan
Position
Assistant Professor
Other areas of specialty/work
Street address
School Of Nursing And Midwifery, Shiraz University Of Medical Sciences
City
Shiraz
Postal code
1978-71345
Phone
+98 71336474257
Fax
+98 71 9361 3119
Email
zarshenas@sums.ac.ir; stud1817297376@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz University Of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
Assistant Professor
Other areas of specialty/work
Street address
Zand Street, Shiraz University Of Medical Science
City
Shiraz
Postal code
1978-71345
Phone
+98 71336474257
Fax
Email
zarshenas@sums.ac.ir; stud1817297376@sums.ac.ir
Web page address

Person responsible for updating data

Contact

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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