comparison of the effect of family-centered empowerment model based lifestyle modification on quality of life of female patients with Pemphigus Vulgaris and active family member in the intervention group with no implementation of the model in patients and active family member in the control group.
The purpose of this study is to investigate of effect of family-centered empowerment model based lifestyle modification on quality of life of patients with Pemphigus Vulgaris and active family members. This is a clinical trial study. Inclusion criteria are register Pemphigus Vulgaris according to the doctor's diagnosis in the health case; women aged 30-60 years; having at least literacy to complete the Questionnaire; type of disease (skin, mucous and skin - mucous); severity of illness (off, mild, moderate, severe); duration of illness (less than three months, between three months to one year, between one year and three years, more than three years). Exclusion criteria are the patient and active family member's unwillingness to continue to participate in research; the patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death. The intervention for the intervention group in order to empowering patients is through theoretical and practical training and for the control group, intervention is not performed. After executing the model the end-of-power level will be compared with the initial ability level. According to the analysis of life style Questionnaire, Sf-36 quality of life Questionnaire and empowerment measurement Questionnaire; theoretical and practical training is given and its impact on patients' quality of life is measured. The sample size is 144 people which are divided into two groups of 72 people
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017061934632N1
Registration date:2017-08-16, 1396/05/25
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Maryam Ghasemi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 7688
Email address
maryamghasemi254@gmail.com
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of family-centered empowerment model based lifestyle modification on quality of life of female patients with Pemphigus Vulgaris and active family member in the intervention group with no implementation of the model in patients and active family member in the control group.
Public title
Family-centered empowerment model for enhance quality of life of female patients with Pemphigus Vulgaris and active family member.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: register Pemphigus Vulgaris according to the doctor's diagnosis in the health case; women aged 30-60 years; having at least literacy to complete the Questionnaire. Exclusion criteria: the patient and active family member's unwillingness to continue to participate in research; the patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Health services research
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Postal code
14115-116
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.TMU.REC.1395.404
Health conditions studied
1
Description of health condition studied
Pemphigus Vulgaris
ICD-10 code
L10, L11,
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
lifestyle
Timepoint
Before intervention- two months after the end of the intervention