The purpose of the study:
The effect of self-care education on quality of life of Parkinson's patients referred to Imam Reza (AS) Shiraz University of Medical Sciences in 1396
Design study:
Quantitative, functional, non-experimental descriptive, causal-comparative survey, random.
Inclusion criteria: patients with primary diagnosis of Parkinson's that approved by neurologist and follow UK Parkinson Disease Society diagnostic criteria; patients who are in stage 1 to 4 according to the Hoehn and Yahr standard scale; absence of dementia using MMSE diagnostic test. Exclusion criteria: conditions or diseases that lead to a change in the person's physical performance so that is not capable of self_care activities.
Study population: Patients with primary diagnosis of Parkinson's that approved by UK Parkinson Disease Society diagnostic criteria referred to Imam Reza (AS) Shiraz University of Medical Sciences in 1396
Target sample size:76
Intervention:
Self-care education to Parkinson's patient that divided Intervention group into four smaller groups and participate each one to the six 45-minute sessions over six weeks which will be held one day a week with the aim of promoting knowledge and awareness of the disease patients and complications of the disease.Empower and strengthen the ability of patients in order to make them self-sufficient to take care of themselves and compliance with changes in physical condition and their function. Finally 1 month and 2 months after the educational program parkinson disease quality of life questionnaire will be completed by the patients.
Intervention time: 14 weeks
Primary outcome measure: quality of life in patient with parkinson's
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052528061N1
Registration date:2017-06-14, 1396/03/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Sharare sadat Shadizad
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 320 7019
Email address
stud2280303159@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on quality of life of Parkinson's patients referred to Imam Reza (AS) Shiraz University of Medical Sciences in 1396
Public title
The effect of education on quality of life in patients with Parkinson's
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients with primary diagnosis of Parkinson's that approved by neurologist and follow UK Parkinson Disease Society diagnostic criteria; patients who are in stage 1 to 4 according to the Hoehn and Yahr standard scale; absence of dementia using MMSE diagnostic test. Exclusion criteria: conditions or diseases that lead to a change in the person's physical performance so that is not capable of self_care activities.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
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
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Science, Zand Ave, Shiraz
City
Shiraz
Postal code
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
95-7688
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson disease
Primary outcomes
1
Description
Quality of life in patients with Parkinson's
Timepoint
Before the intervention, one month after the end of the intervention, two months after intervention
Method of measurement
De Boer patients with Parkinson's quality of life questionnaire
Secondary outcomes
1
Description
Parkinson's symptoms
Timepoint
Before the intervention, one month after the end of the intervention, two months after intervention
Method of measurement
De Boer patients with Parkinson's quality of life questionnaire
2
Description
Systemic symptoms
Timepoint
Before the intervention, one month after the end of the intervention, two months after intervention
Method of measurement
De Boer patients with Parkinson's quality of life questionnaire
3
Description
Emotional function
Timepoint
Before the intervention, one month after the end of the intervention, two months after intervention
Method of measurement
De Boer patients with Parkinson's quality of life questionnaire
4
Description
Social Performance
Timepoint
Before the intervention, one month after the end of the intervention, two months after intervention
Method of measurement
De Boer patients with Parkinson's quality of life questionnaire
Intervention groups
1
Description
Intervention group:
Divided Intervention group into four smaller groups and participate each one to the six 45-minute sessions over six weeks educational program which will be held one day a week with the aim of promoting knowledge and awareness of the disease patients and complications of the disease.Empower and strengthen the ability of patients in order to make them self-sufficient to take care of themselves and compliance with changes in physical condition and their function. Finally 1 month and 2 months after the educational program parkinson disease quality of life questionnaire will be completed by the patients.
Category
Other
2
Description
Control group: no intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza (AS)
Full name of responsible person
Zahra Zare
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Roxana Jan ghorban
Street address
School of Nursing and Midwifery, Namazi Square
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
School of Nursing and Midwifery
Full name of responsible person
Hashem Rahmati
Position
Master of Science in Nursing / Coach
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4258
Fax
Email
Rahmati@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Hashem Rahmati
Position
Master of Science in Nursing / Coach
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4258
Fax
Email
Rahmati@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Sharare sadat Shadizad
Position
Bachelor of Nursing/ student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square
City
Shiraz
Postal code
Phone
+98 71 3647 4256
Fax
Email
Stud2280303159@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)