Protocol summary

Study aim
Effect Of Intervention According to Progressively Lowered Stress Threshold Model On Promotion Of Care Process.
Design
the controlled clinical trial enrolled between October 2016 and September 2018 and followed for one month.according to the similar study, the sample size 38 people the available is in this group.
Settings and conduct
Alzheimer's Elderly Care Center in Isfahan
Participants/Inclusion and exclusion criteria
Having experience or being in the care of the elderly with dementia, Ability to communicate in expressing experiences, Interested in clear expression
Intervention groups
The number of training sessions for the intervention group is 2 consecutive . about 3 hours
Main outcome variables
Increasing the Control of Challenging Behaviors in Patients with Dementia , improving the performance of caregivers of patients with dementia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180421039370N1
Registration date: 2019-01-11, 1397/10/21
Registration timing: retrospective

Last update: 2019-01-11, 1397/10/21
Update count: 0
Registration date
2019-01-11, 1397/10/21
Registrant information
Name
Fatemeh Raeesi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 7805
Email address
me.nakhodaeezadeh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploration of Experiences of Caregivers in patient with Demance's disease , Developing Educational Masseges &Determining Effect Of Intervetion According to PLST Model On Promotion Of Care Process.Mixed Method Study
Public title
Effect Of Intervetion According to PLST Model On Promotion Of Care OF Elderly with Demance's Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly dementia caregivers with who have been diagnosed for at least one year
Exclusion criteria:
1. The lack of cooperation in study 2- lack of desire to participate in training sessions over a one meeting
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Actual sample size reached: 38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of isfehan University of Medical Sciences
Street address
isfehan University of Medical Sciences, Hezarjarib Blvd
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
IR.MUI.REC.1395.3.204

Health conditions studied

1

Description of health condition studied
improvement of Dementia care process
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Increased control of the challenging behaviors of patients with dementia
Timepoint
3 month
Method of measurement
questionaire from qualititative study

Secondary outcomes

1

Description
improvement of caregivers of demantia patient
Timepoint
3 month
Method of measurement
researcher made questionaire

Intervention groups

1

Description
The number of training sessions for the intervention group is 2 consecutive. The time frame will be about 3 hours (two consecutive days) and the goal is that the intervention group (caregivers), based on this model, has methods of communication and dealing with behaviors Learn the patient's challenging, ongoing care process. In fact, with this intervention, he takes care of management and care planning, as well as on dementia, probable prevention, illness, methods of self-efficacy and many other skills provided in the form of systematic(based on PLST model) tables. This study administrated without control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadeghie & White Rainbow Elderly Nursing Home in Isfahan
Full name of responsible person
Shakiba Zahed
Street address
University of Technology Square, Amin Abad Blvd, Sadeghie Elderly Care Center
City
Isfahan
Province
Isfehan
Postal code
81745-73461
Phone
+98 31 3792 3071
Fax
Email
me.nakhodaeezadeh@uswr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3071
Fax
Email
me.nakhodaeezadeh@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Zahed
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Family Health
Street address
Isfahan University of Medical Sciences. Health School
City
Isfahan
Province
Isfehan
Postal code
81746
Phone
+98 31 3668 0048
Email
me.nakhodaeezadeh@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Zahed
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Isfahan-Hezar Jarib- Isfahan University of Medical Science- Behdasht Campus
City
Isfehan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 8628
Email
Shakiba.Zahed@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shakiba Zahed
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Behdasht Campus, Isfahan University of Medical Science, Hezar Jarib Blvd
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
Shakiba.Zahed@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Result of Intervention on Caregiver in PLST Model
When the data will become available and for how long
6 Month After
To whom data/document is available
Medical Stuff and Researchers
Under which criteria data/document could be used
Educational Contents
From where data/document is obtainable
Department of Health Education & Promotion Isfahan University of Medical Sciences, Isfahan, Iran
What processes are involved for a request to access data/document
Department of Health Education & Promotion Isfahan University of Medical Sciences request
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