Protocol summary
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Study aim
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Assessing effect of the prehabilitation program on discharge readiness and post-surgery outcomes in patients undergoing CABG surgery
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Design
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This study is a randomised clinical trial with a control group, with parallel groups, blinded outcome assesment on 60 patients. After checking the inclusion and exclusion criteria, the eligible patients will be assigned to two groups using a random 4 blocks method.
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Settings and conduct
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Participants will be randomly divided into intervention and control groups. The control group will receive standard care, while patients in the intervention group will receive the nurse-led prehabilitation program including respiratory muscle strengthening exercises, preoperative nutritional guidance, and stress management techniques. In this study, data analysts are blinded to the placement of patients in the intervention or control group.
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Participants/Inclusion and exclusion criteria
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Inclusion criatria are having an on-pump coronary bypass surgery, being on the elective coronary artery bypass surgery list, experiencing Heart surgery for the first time, ability to speak and understand Persian, not having diagnosed with anxiety or other psychological disorders (self-report), non-concurrency of CABG surgery with other surgeries. Exclusion criterias are History of cerebrovascular disease and/or stroke, Previous heart or lung surgery or disesases, Presence of neuromuscular disorder, and Patients with cognitive disorders and/or Alzheimer's disease
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Intervention groups
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The patients with a diagnosis of coronary artery disesase referred to IKHC cardiac surgery clinic will be screened for the eligibility criteria.
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Main outcome variables
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The patients' discharge readiness assessed by nurse and the patient, anxiety and depression before surgery and before discharge, length of stay in the hospital and intensive care unit, duration of intubation.
General information
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Reason for update
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Updating the publication schedule for printing the protocol study article.
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Acronym
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PreCABG
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IRCT registration information
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IRCT registration number:
IRCT20231019059768N1
Registration date:
2024-05-23, 1403/03/03
Registration timing:
prospective
Last update:
2025-04-02, 1404/01/13
Update count:
1
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Registration date
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2024-05-23, 1403/03/03
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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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2024-05-30, 1403/03/10
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Expected recruitment end date
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2024-07-21, 1403/04/31
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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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Impact of prehabilitation program on discharge readiness and surgery outcomes in patients going on a coronoray artery bypass Graft
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Public title
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prehabilitation in patients going on a coronoray artery bypass Graft
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having an on-pump coronary bypass surgery
Being on the elective coronary artery bypass surgery list
Experiencing Heart surgery for the first time
Ability to speak and understand Persian
Not having diagnosed with anxiety or other psychological disorders (self-report)
Non-concurrency of CABG surgery with valve replacement or other surgeries
Exclusion criteria:
Emergency surgery
History of cerebrovascular disease and/or stroke
Previous heart or lung surgery
Presence of neuromuscular disorder
Previous COPD disease
Vulvar diseases
Patients with cognitive disorders and/or Alzheimer's 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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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The samples will be selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). By using the free website http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block will be set to 6, for the control group letter A and for the case group, the letter B will be considered, and finally, by approving the Randomization Sequence in the system for 10 blocks, The assignment sequence will be created for the 60 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, a Shuffling Envelope will be taken by the researcher accidentally. Finally, the random allocation method will be determined by the research samples.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, data analysts are blinded to the placement of patients in the intervention or control group.
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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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2023-10-10, 1402/07/18
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1402.287
Health conditions studied
1
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Description of health condition studied
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Ischemic heart disease
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ICD-10 code
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I25
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ICD-10 code description
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Chronic ischemic heart disease
Primary outcomes
1
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Description
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Score of patients' Discharge readiness assessed by Nurse
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Timepoint
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Immediately after making discision to discharge the patient
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Method of measurement
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According to readiness for hospital discharge scale RN assessment short form
2
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Description
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Score of patients' Discharge readiness by patient
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Timepoint
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Immediately after making discision to discharge the patient
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Method of measurement
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According to readiness for hospital discharge scale short form
3
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Description
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Anxiety score in hospital anxiety and depression scale (HADS)
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Timepoint
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At the beginning of the study (before the start of the intervention), and the night before the surgery, and immediately after making discision to discharge the patient.
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Method of measurement
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Hospital anxiety and depression scale (HADS)
4
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Description
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Depression score in hospital anxiety and depression scale (HADS)
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Timepoint
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At the beginning of the study (before the start of the intervention), and the night before the surgery, and immediately after making discision to discharge the patient.
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Method of measurement
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Hospital anxiety and depression scale (HADS)
5
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Description
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Duration of stay in the hospital
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Timepoint
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After patient's dicharge
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Method of measurement
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Based on the duration of hospitalization documented in the patient's files
6
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Description
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Duration of stay in intensive care unit
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Timepoint
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After patient's dicharge
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Method of measurement
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Based on the duration of stay in the intensive care unit documented in the patient's files
7
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Description
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Duration of intubation time
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Timepoint
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After patient's dicharge
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Method of measurement
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Based on the duration of intubation time documented in the patient's files
Intervention groups
1
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Description
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This intervention includes 1) communication between the researcher nurse and the patient 2) a general explanation about the surgical procedure in a way that does not cause anxiety 3) encouraging the patient to talk about his/her concerns and their causes and correcting the patient's inappropriate thoughts 4) introduction Stress management methods that include progressive muscle relaxation, deep breathing, and guided imagery and then teaching and practicing the preferred method to the patient. 5) Providing recommendations related to the type of nutrition before the operation, including consuming fewer carbohydrates, and consuming more foods containing protein, vitamins, and micronutrients. 6) Advising to quit smoking if needed and teaching exercises related to strengthening the respiratory muscles, such as using the pursed-lip breathing method to the patient and practicing these methods until the exercises are performed correctly by the patient. In this way, the eligible samples in the heart surgery clinic will be selected, and after obtaining informed consent; a demographic information questionnaire, hospital anxiety and depression scale, and Duke physical activity scale will be completed by volunteers. In the case of the test group, considering that heart surgery patients enter the study about 7 days before the surgery, the researcher starts his intervention one week before the surgery. In the first session, face-to-face training will take place in the heart surgery clinic, and at the same time, a complete Prehabilitation booklet will be provided to the patient. The second and third sessions will be held in the afternoon (between 16:00 and 18:00) in the patient's heart surgery department. In the second and third sessions of the intervention, while reviewing the teachings discussed in the first session, the patient is encouraged to raise issues that occupy his mind, the researcher answers the patient's questions, and then the patient's preferred stress management method and breathing exercises are performed. Each session lasts about 45 to 60 minutes based on the patient's needs. In the case of both control and test groups, routine care including drug therapy and hemodynamic control of the patient is performed. On the day of surgery, the hospital anxiety and depression scale questionnaire will be filled again by the patient. On the morning of the discharge, the hospital anxiety and depression scale and the discharge readiness questionnaire are filled by the patient. Also, the discharge readiness questionnaire from the nurse's point of view is completed by his/her direct nurse. The checklist including the length of stay in the ICU, the length of intubation, the length of stay in the hospital, the approximate time of the patient's mobility, and the observation of atelectasis (according to the doctor's diagnosis) will be completed by the researcher. Also, after 30 days, the patient will be contacted and asked about re-hospitalization and the patient will be asked to complete Duke's physical activity questionnaire that was given to him on the day of discharge and send it to the researcher through messengers.
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Category
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Rehabilitation
2
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Description
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The control group will receive routine care including drug therapy and hemodynamic monitoring. The eligible samples in the heart surgery clinic will be selected, and after obtaining informed consent; a demographic information questionnaire, hospital anxiety and depression scale, and Duke physical activity scale will be completed. On the day of surgery, the hospital anxiety and depression scale questionnaire will be filled again by the patient. On the morning of the discharge, the hospital anxiety and depression scale and the discharge readiness questionnaire are filled by the patient. Also, the discharge readiness questionnaire from the nurse's point of view is completed by his/her direct nurse. The checklist including the length of stay in the ICU, the length of intubation, the length of stay in the hospital, the approximate time of the patient's mobility, and the observation of atelectasis (according to the doctor's diagnosis) will be completed by the researcher. Also, after 30 days, the patient will be contacted and asked about re-hospitalization and the patient will be asked to complete Duke's physical activity questionnaire that was given to him on the day of discharge and send it to the researcher through messengers.
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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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Tehran 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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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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data includes demographic information (such as age and gender), discharge readiness, duration of intubation, ICU stay, occurrence of atelectasis, onset of mobility, hospital stay, and levels of anxiety and depression. Additionally, data related to the 30-day readmission rate have been collected. All individual participant data will be processed through anonymization prior to sharing to ensure the privacy of individuals is protected. However, due to the sensitivity of the data and ethical considerations, only a portion of the data, particularly information related to primary outcomes (such as discharge readiness), will be available for public sharing. More sensitive data, such as detailed demographic information or specific clinical details, will only be provided to authorized researchers for specific research purposes with official permission.
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When the data will become available and for how long
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Access period begins after results are printed.
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To whom data/document is available
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We have a rigorous process in place to ensure that only qualified researchers who are affiliated with academic or research institutions and who can demonstrate their qualifications and data protection measures are given access. This access is exclusively for research purposes, safeguarding the integrity and security of our data.
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Under which criteria data/document could be used
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Data access is limited to research matching the study's goals and ethics. Researchers must sign an agreement banning re-identification and detailing non-commercial use. Analyses may need approval; publications require pre-approval for data integrity. Documents are restricted to related research per the agreement.
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From where data/document is obtainable
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Data can be accessed by contacting the corresponding author via provided email.
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What processes are involved for a request to access data/document
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Data can be accessed by contacting the corresponding author via provided email. The response is expected to be provided within two weeks.
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Comments
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