Protocol summary
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Study aim
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Health services
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Design
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matched controlled clinical trial study; parallel group; No blinding; Simple randomization using lottery.
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Settings and conduct
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This matched controlled clinical trial study was conducted by Purposive sampling 72 female patients with Pemphigus Vulgaris and 72 active family members and through random allocation was divided into two groups: intervention and control. Data were collected by demographic, specialty instrument of empowerment of patients and specialty instrument of active family members questionnaires, Lifestyle (HPLP II) and SF-36 for patients and active family members , dermatology life quality index, the family Dermatology life quality index (FDLQI) questionnaires. FCEM implemented in steps (perceived threat, self-efficacy, self-esteem and evaluations) for the intervention group. Usual care was done for control group. After 6 weeks, was compared with the control. Data was analyzed by statistical software SPSS V.24, and rate (P <0.05) was considered significant.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: register Pemphigus Vulgaris in the health case; Patients' and active family member's satisfaction ; Ability to communicate; No mental illness or other acute or chronic illness; Not a member of health team and having at least literacy. Exclusion criteria: the patient and active family member's unwillingness to continue; patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death.
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Intervention groups
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female patients with Pemphigus Vulgaris and active family member in two groups of intervention and control.
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Main outcome variables
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Quality of public and Exclusive life of female patients with Pemphigus Vulgaris and active family member.
General information
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Reason for update
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Add primary and secondary outcome variable
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017061934632N1
Registration date:
2017-08-16, 1396/05/25
Registration timing:
retrospective
Last update:
2022-08-07, 1401/05/16
Update count:
1
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Registration date
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2017-08-16, 1396/05/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tarbiat Modares University
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Expected recruitment start date
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2017-06-22, 1396/04/01
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Expected recruitment end date
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2017-08-23, 1396/06/01
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Actual recruitment start date
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2017-06-22, 1396/04/01
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Actual recruitment end date
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2017-07-23, 1396/05/01
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Trial completion date
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2017-09-23, 1396/07/01
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Scientific title
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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.
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Public title
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Family-centered empowerment model for enhance quality of life of female patients with Pemphigus Vulgaris and active family member.
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
register Pemphigus Vulgaris according to the doctor's diagnosis in the health case
women aged 30-60 years
Patients' and active family member's desire and satisfaction to participate in the research;
Ability to communicate verbally ; provide information and collaborate with the researcher
No mental illness or other acute or chronic illness
Not a member of the health team
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
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Age
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From 30 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
144
Actual sample size reached:
144
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the research samples were selected by the researcher using the purposeful sampling method by studying the patients' files to reach the qualified patients more precisely, according to the entry criteria and after assimilation by one of the nurses based on the criteria of age, type of disease, severity of the disease and duration of the disease, the block was randomly assigned and then, using the Minimization method, the samples were homogenized by SPSS software and by using lottery and randomly, the research samples were placed in one of the control or intervention groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-11-09, 1395/08/19
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Ethics committee reference number
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IR.TMU.REC.1395.404
Health conditions studied
1
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Description of health condition studied
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Pemphigus Vulgaris
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ICD-10 code
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L10.0
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ICD-10 code description
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Pemphigus vulgaris
Primary outcomes
1
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Description
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lifestyle
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Timepoint
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Before intervention- two months after the end of the intervention
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Method of measurement
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Walker- Pender health-promoting Lifestyle Questionnaire
Secondary outcomes
1
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Description
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Quality of public life of female patients with Pemphigus Vulgaris and active family member
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Timepoint
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Before intervention; two months after the end of the intervention
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Method of measurement
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SF-36 quality of life Questionnaire
2
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Description
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Quality of Exclusive life of female patients with Pemphigus Vulgaris
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Timepoint
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Before intervention; two months after the end of the intervention
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Method of measurement
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Iranian version dermatology life quality index (DLQI)
3
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Description
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Quality of exclusive life of active family member.
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Timepoint
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Before intervention; two months after the end of the intervention.
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Method of measurement
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The family dermatology life quality index (FDLQI).
Intervention groups
1
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Description
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After analyzing the data before the intervention, which led to the identification of the resources, limitations, needs and strengths of the patient and his active family member in different fields, Changes were made in the previously designed empowerment program for these patients, so that the implementation of the empowerment model fits the needs and demands of the research samples. After the pre-test, the intervention phase began and since this study was conducted as an intervention and control; The intervention phase was performed only for the intervention group and the control group did not receive any intervention. In the intervention group, the family-centered empowerment model in executive steps (understanding the threat, internalizing the axis of control, self-efficacy, self-belief, self-control, follow-up and evaluation) for 8 sessions by group problem solving method and using educational participation method and adult educational theory for The intervention group was implemented and after 6 weeks, were compared with the control group.
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Category
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Lifestyle
2
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Description
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Conducting the pre-test by completing the demographic information questionnaire, the Iranian version of the quality of life index questionnaire for skin patients (DLOQI), the quality of life questionnaire (SF-36), the family specific questionnaire of skin patients (FDLOQI), the Iranian version of the Walker and Pender lifestyle questionnaire, Questionnaire for measuring the patient's ability and questionnaire for measuring the ability of the active family member by the patient and the active family member and conducting post-test 6 weeks after the completion of the intervention in the intervention group by re-completing the main tools for measuring lifestyle and quality of life by the patient and active family member.
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Category
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N/A
1
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Sponsor
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Grant name
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121000
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Grant code / Reference number
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52د/8712
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available