Protocol summary

Summary
This study was a randomized non-blinded controlled clinical trial. We enrolled 100 elderly people who were under the support of Ilam Welfare Organization, western Iran in 2013. Balanced block randomization method was used to randomize the participants into case and control groups. Inclusion criteria :Age over 60 years; No risk of dementia; ability to communicate visually and verbally and participate in the reminiscence classes. exclusion criteria: Cognitive state assessment scores less than 10. In the case group participated in a group reminiscence program consisted of two one-hour sessions per week for 8 consecutive weeks. Data were collected using Mini Mental State Examination. The questionnaire was completed four times by the participants; before, immediately after, two and three months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405147531N7
Registration date: 2014-06-19, 1393/03/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-19, 1393/03/29
Registrant information
Name
Iran Jahanbin
Name of organization / entity
University of Medical Sciences Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 917 313 7399
Email address
jahanbii@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-10-10, 1392/07/18
Expected recruitment end date
2014-06-06, 1393/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Group Reminiscence on the Cognitive Status of Elderly
Public title
The Effect of Group Reminiscence on the Cognitive Status of Elderly People Supported by Ilam Welfare Organization in 2013
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria :Age over 60 years ;No risk of dementia; ability to communicate visually and verbally and participate in the reminiscence classes. exclusion criteria: Cognitive state assessment scores less than 10.
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2013-04-28, 1392/02/08
Ethics committee reference number
92-6922

Health conditions studied

1

Description of health condition studied
Cognitive
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder

Primary outcomes

1

Description
Cognitive
Timepoint
The questionnaire was completed four times by the participants; before, immediately after, two and three months after the intervention.
Method of measurement
Standard questionnaire Mini Mental State Examination

Secondary outcomes

empty

Intervention groups

1

Description
Elderly people in the case group participated in a group reminiscence program consisted of two one-hour sessions per week for 8 consecutive weeks. Data were collected using Mini Mental State Examination . The questionnaire was completed four times by the participants; before, immediately after, two and three months after the intervention.
Category
Other

2

Description
The elderly participants of the control group received no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ilam Welfare Organization
Full name of responsible person
Fatemh Mohammadnejad
Street address
Beheshti Street , Darreh Shahr ,Ilam Welfare Organization
City
Darreh Shahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Vice chancellor for research Shiraz University of Medical Sciences, The Seventh floor, Central Building of Shiraz University of Medical Sciences, 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
College of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Mohammadnejad
Position
Master of Nursing
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Namazi
City
Shiraz
Postal code
Phone
+98 918 948 1635
Fax
Email
mohamadnezhad@sums.ac.ir saranursing68@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Nursing and Midwifery, Shiraz
Full name of responsible person
IranJahanbin
Position
Master of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
College of Nursing and Midwifery, Namazi
Postal code
Phone
+98 71 14254
Fax
Email
jahanbii@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
College of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Mohammadnejad
Position
Student Master of Nursing
Other areas of specialty/work
Street address
Imam Khomeini Street , Darreh Shahr ,Ilam
City
Darreh Shahr
Postal code
Phone
Fax
Email
Saranursing68@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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