Protocol summary
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Study aim
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Determining the effect of home nursing care on the quality of life of patients with major depression in 1399 in Razi Psychiatric Educational and Medical Center in Urmia
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Design
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A clinical trial with a control group, without blindness, randomized on 50 patients, was used to randomize the card in two ways: control and intervention and selection of each card by the participants.
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Settings and conduct
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The research population includes clients with a diagnosis of major depression in Razi Psychiatric Educational and Medical Center in Urmia. Using the available sampling method and taking into account the sample size, 50 people with inclusion criteria will be selected and randomly placed in two groups of intervention and control. The control group will not receive home nursing care. . The home care program for the intervention group will be 5 to 6 sessions once every two weeks for 1.5 to 2 hours over 3 months. The McGill Questionnaire will be completed again.
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Participants/Inclusion and exclusion criteria
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1.Definitive diagnosis of major depression recorded in the patient file
2. Willingness to collaborate in research
3. Lack of mental retardation based on the case
4. Living in the city of Urmia or Khoy
5. Age range 18 to 60 years
6. Able to speak Turkish or Persian and answer questionnaires
7. No drug addiction except smoking
8. Not living in a shelter covered by support centers
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Intervention groups
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The patient is randomly selected and receives nursing care in the intervention group every 3 months and every two weeks, and the control group does not receive any intervention.
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Main outcome variables
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Improving the quality of life; increasing efficiency; reducing the length of hospital stay; preventing recurrence and readmission
General information
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Reason for update
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The sampling date was selected from 17.5 and the date of receipt of the code is 22.5, while in practice the sampling was after obtaining the code and the reason for this difference was due to the registration of the sampling date and the requested edits after that by the center and interruption. has been created
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140212016564N13
Registration date:
2020-08-12, 1399/05/22
Registration timing:
prospective
Last update:
2021-07-05, 1400/04/14
Update count:
1
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Registration date
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2020-08-12, 1399/05/22
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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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Expected recruitment start date
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2020-08-15, 1399/05/25
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Expected recruitment end date
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2020-08-29, 1399/06/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of home nursing care on the quality of life in patient with major depression referring to educational-trearment Razi psychiatric center of Urmia in 2019-2020
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Public title
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The effect of home nursing care on the quality of life in patient with major depression referring to educational-trearment Razi psychiatric center of Urmia in 2019-2020
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Purpose
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Other
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Inclusion/Exclusion criteria
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Inclusion criteria:
Definitive diagnosis of major depression recorded in the file
Willingness to cooperate
Lack of mental retardation
Able to speak Persian or Turkish
No drug addiction except smoking
Lack of residence in accommodation covered by welfare
Age between 18-60 years
Exclusion criteria:
Lack of patient consent to continue treatment
Long-distance travel and transfer to another city
Exacerbation of the disease and hospitalization
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Age
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From 18 years old to 60 years old
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Gender
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Both
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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:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using the available sampling method and taking into account the drop in samples, 50 people with inclusion criteria were selected and randomly selected in the stages of preparation for discharge of patients who have a diagnosis of major depression in the file by selecting one of the two cards containing the group content. The intervention or control group is divided into two groups) will be divided into two groups of intervention and control. Thus, each of the intervention groups will have 25 people and the control group will have 25 people. The control group will not receive home nursing care. The groups will fit together and there will be the same number of people receiving ECT in both 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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2019-10-07, 1398/07/15
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Ethics committee reference number
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IR.UMSU.REC.1398.268
Health conditions studied
1
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Description of health condition studied
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major depression
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ICD-10 code
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F06.3
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ICD-10 code description
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Mood disorder due to known physiological condition
Primary outcomes
1
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Description
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Quality of life
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Timepoint
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Before intervention and 3 months later and 6 months after
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Method of measurement
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Quality of life score in MC GILL questionnaire
Intervention groups
1
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Description
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Intervention group: Home nursing care Implementation of home care program for the intervention group in 5 to 6 sessions once every two weeks for 1.5 to 2 hours for 3 months depending on the needs of patients and telephone follow-up program in the first month After discharge 3 times a week, in the second month 2 times a week and in the third month after discharge once a week.The care provided by the researcher includes client assessment, scheduling that includes counseling and training programs, and intervention programs. In educational programs, education is provided to the patient and family on how to use drugs and side effects, communication skills, social skills, self-care and help to better understand the disease and existing treatments. They will be face to face and orally.
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Category
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N/A
2
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Description
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Control group: They do not receive any intervention
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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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Grant code / Reference number
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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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Oroumia University of Medical Sciences
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Documentation will be published in the form of an article. All demographic characteristics such as age, sex, level of education, job position, suicide, receiving ECT can be published. Also, the quality of life in people can be published
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When the data will become available and for how long
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Access starts 3 months after the results are published
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To whom data/document is available
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Available to all researchers in the field of psychiatry
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Under which criteria data/document could be used
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Compare demographic characteristics with quality of life or two groups with each other
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From where data/document is obtainable
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Radfar: Associate Professor Mradfar1343@gmail.com
Mahsa Koohi: Master of Urmia University of Medical Sciences mahsa2144@gmail.com-09382892144
Leila Aliloo: Assistant Professor Urmia University of Medical Sciences aliluleiyla@gmail.com
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What processes are involved for a request to access data/document
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Send e-mail and in case of no response after one day by phone and coordination with research members and if you agree to provide information for about a week
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Comments
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