Protocol summary
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Study aim
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Determining the impact of family-centered care based on Betty Newman's systemic model on the quality of life of patients with type 2 diabetes
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Design
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A randomized controlled clinical trial
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Settings and conduct
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The research population is all patients with type 2 diabetes referring to Imam Reza (AS) health center in Esfrain city.
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Participants/Inclusion and exclusion criteria
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Diagnosing type 2 diabetes according to the internist's opinion
Having a history of type 2 diabetes for more than one year
The ability of the patient to understand and speak Persian
Possibility of direct contact with the patient
In the critical phase of the disease
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Intervention groups
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After explaining the objectives of the research and obtaining the research consent, a demographic and quality of life questionnaire was filled out for all patients, and then the Newman evaluation form was completed for them during an interview with all patients in the intervention group. After the data were analyzed, nursing diagnoses based on Nanda It will be determined for patients in the intervention group.In the intervention group, introduce a first-class family member (spouse, parents, children, siblings) who had the most interaction and communication with him. Family-centered care for the intervention group is performed in 2 months, first, the educational needs of the patient with diabetes are determined through the Newman form and based on nursing diagnoses. Then the active member of the family in the intervention group will be trained about diabetes based on the nursing diagnosis.One month after the completion of the training, the quality of life questionnaire will be filled again by the patients of the test and control groups, and the quality of life measured in both the test and control groups before and after the intervention will be compared.
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Main outcome variables
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Quality of life based on Newman's systemic model
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200504047296N1
Registration date:
2023-05-29, 1402/03/08
Registration timing:
registered_while_recruiting
Last update:
2023-06-12, 1402/03/22
Update count:
1
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Registration date
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2023-05-29, 1402/03/08
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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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2023-05-21, 1402/02/31
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Expected recruitment end date
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2023-08-21, 1402/05/30
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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 family- centered care based on Newman's systemic model on the quality of life in patients with diabetes type 2
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Public title
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The effect of family - centered care based on Newman's systemic model on the quality of life in patients with diabetes type 2
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient's condition: diagnosis of type 2 diabetes according to internal specialist's opinion
Having a history of type 2 diabetes for more than one year
The patient's ability to understand and speak Persian
Conditions of one of the patient's family members: having literacy to read and write
Willingness to participate in patient accompanying meetings
Hearing the patient's words from him
Living with the patient
Exclusion criteria:
In the critical phase of the disease
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Age
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No age limit
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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:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the first stage, sampling is done in a purpose-based manner, and the eligible samples are selected based on the study entry criteria, then they are randomly assigned to two test and control groups by block method with blocks of 4 people. The simple random method causes the inequality of people in two groups, which reduces the statistical power of the test used. Therefore, by using the block method with random allocation, the people assigned to two groups are equal to each other. To avoid predicting the allocation of people in the group, blocks of different sizes (blocks of 4 people and 6 people) are determined. Then, by entering the information of the number of blocks, groups and total samples to reliable sites such as "https://www.sealedenvelope.com/simple-randomiser/v1/lists", the order of people is assigned to groups, similar to the information below. be.
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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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2023-04-17, 1402/01/28
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1402.020
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes
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ICD-10 code
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E11.8
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ICD-10 code description
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Type 2 diabetes mellitus with unspecified complications
Primary outcomes
1
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Description
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Quality of Life
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Timepoint
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At the beginning of the study and three months after the intervention
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Method of measurement
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Summarized clinical questionnaire of the quality of life of diabetic patients
Intervention groups
1
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Description
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Intervention group: The intervention in this study includes teaching the diet plan of diabetics - teaching the general principles of diabetic foot care - teaching prevention methods - giving awareness and information about the disease - allowing the patient to express his feelings - regular blood sugar control - exercising the feet - Daily walk, regular use of diabetic medication - Regular examination of the skin of the limbs - Recommendation for regular examination by an ophthalmologist - Regular blood sugar control - Training on warning signs and prevention methods - Regular blood pressure control - Training on diet plan for diabetic patients - Previous blood sugar control Sleep-recommendation to exercise before going to sleep-not consuming caffeinated substances before going to sleep-providing a calm environment for sleeping-teaching the patient about the disease and how to control and prevent complications in the form of face-to-face meetings and preparation of educational pamphlets. The sessions are tailored to the educational needs of the patients and are at least 6 sessions of 30 minutes. A meeting will be held every week. The nursing diagnoses related to each patient will be determined based on the completion of the Newman evaluation form by the participating members of the intervention group, and the care plan will be designed and implemented based on the nursing process. that nursing diagnoses based on Nanda Nursing Diagnosis (Nursing Diagnosis Institute of North America) along with related nursing care will be implemented for each patient privately.
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Category
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Lifestyle
2
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Description
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Control group: The control group will only complete the quality of life questionnaire and demographic characteristics. The duration of the intervention lasts a maximum of 2 months, and one month after the end of the intervention, the quality of life questionnaire will be completed again.
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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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Islamic Azad 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The results of the data will be published in general and without identification code.
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When the data will become available and for how long
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After the decision of the journal to accept and publish the results in the form of an article
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To whom data/document is available
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magazine's editor in chef
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Under which criteria data/document could be used
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Checking the quality and scientific validity of the study
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From where data/document is obtainable
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SOMAYE RAHIMI
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What processes are involved for a request to access data/document
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After receiving the request, the editor of the magazine will decide which part of the information can be published, and after removing any identification code, the desired data will be sent by email.
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Comments
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