Determining the effect of group hope therapy on the quality of life of elderly people in Kashan in 1396
Design
This clinical trial study was performed on two groups of control and intervention that were randomly selected and blinded one by one.
Settings and conduct
clinical trial study in two experimental group (group of hope therapy) and control group (recipient of routine services of comprehensive health center) will be done in the elderly people covered by selected comprehensive health centers in Kashan(Akramian, moslem ebne aghil, sadeghpur).
Participants/Inclusion and exclusion criteria
including criteria:
Satisfaction to participate in the study,
Age 75-60 years old,
Iranian citizenship,
Can communicate in Persian language,
Non-use of psychiatric drugs,
Non-inclusion criteria:
Having a cognitive and psychotic problem,
High quality of life,
Intervention groups
elderly people between 60-75 years old
Main outcome variables
Way of life;
quality of life
General information
Reason for update
Acronym
امید درمانی در سالمندان
IRCT registration information
IRCT registration number:IRCT20180517039697N1
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Ghazale Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 2961
Email address
ebhpj@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group hope therapy on the quality of life in elderly
Public title
The Effect of Hope Therapy on the Elderly
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Age 75-60 years old
Ability to communicate in Persian language
Iranian nationality
Earn less than 75 points (from a scale of 0-100) from the Lipad Quality of Life tool
Exclusion criteria:
Acute serious physical or psychological illness
known psychological illness
afflicted with mental retardation
cognitive impairment
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned blocks in the form of blocks 4, 6 and 8 to each of the two groups. Using the site www.sealedenvelope.com 3 blocks of 4 blocks, 4 blocks of 8 and 2 blocks of 6 were defined in total 9 blocks. The blocks are divided into 3 categories according to the list taken from the site (one third of the elementary, middle and end of the list) and randomly each block of blocks from a center will be considered
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analysis will be done by people who do not have the code information.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
ghotbe ravavndi BLV
City
kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2018-05-07, 1397/02/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.003
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
F59
ICD-10 code description
Unspecified behavioral syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
quality of life
Timepoint
Immediately after the intervention and one month later
Method of measurement
lipad elderly quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 8 sessions of 90 minutes (weekly 2 sessions with a minimum of two days interval) by the third-party sponsor under the supervision of the first guide's mentor (Psychiatric Nurse), the Hope Therapy Program, which is based on the Schneider Protocol (1999). In the program, each session consists of four sections. In the first part, about 20 minutes are discussed about the activities and assignments of the past session, and the elderly are encouraged to help each other solve the problems associated with those assignments. It should be noted that during the first session, which still has no assignment, this section The session will be devoted to explaining the goal definition and its barriers, and the ways to achieve the goal and strategy of maintaining incentives. In the second part, about 20 minutes of hope skills are taught in three areas: goals, passages and factors; in the third part, which lasts about 40 minutes, discuss how to use these skills in everyday life. And people are encouraged to present issues in a clear and objective way and help each other to solve their hopes using their skills. In the final 10 minutes of the meeting, the assignments for the next meeting will be presented. At the eighth session, which is the last session of treatment, you will first review the past sessions and then explain how this process of treatment continues in personal life so as to prevent disappointment in everyday life.
Category
Lifestyle
2
Description
Control group: After identifying the samples, They will receive routine center services (assessment of physical problems and related therapeutic interventions).
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers
Full name of responsible person
Ghazale Jalali
Street address
Ghotbe Ravandi BLV
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
ghazalejalali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Research Deputy of Kashan University of Medical Science
Street address
Ghotbe Ravandi BLV
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
ghazalejalali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
GhazaleJalali
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghotbe Ravandi BLV
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
ghazalejalali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Khadijeh Sharifi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghotbe Ravandi BLV
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0021
Email
sharifi81k@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ghazale Jalali
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghotbe Ravandi BLV
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5557 8010
Email
ghazalejalali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be received in the form of a questionnaire from the participants and will eventually be shown in the table.
When the data will become available and for how long
6 month after publication
To whom data/document is available
for everyone who interested in subject
Under which criteria data/document could be used
no specific condition is required
From where data/document is obtainable
email to this address ghazalejalali@yahoo.com
What processes are involved for a request to access data/document