Protocol summary
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Study aim
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Comparison of the efficacy of discharge planning based on continuous care model and cardiac rehabilitation on health related outcomes of patients after coronary artery bypass graft surgery
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Design
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This study is conducted as a combined embedded study. The quantitative part of the study of the clinical trial type and 88 patients undergoing coronary artery bypass graft surgery were assigned in two groups (intervention and control) by random block method.
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Settings and conduct
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This study will be carried out in Farshchian Cardiac center, affiliated to the Hamadan University of Medical Sciences in Hamadan.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients after coronary artery bypass grafting; desire to participate in the study; Proportion to one member of family to patient. Exclusion Criteria: Heart Failure class III and IV; Positive exercise test; Severe musculoskeletal problems; did not have access to a smartphone; on medication for psychiatric disorders.
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Intervention groups
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Intervention group: Patients will receive a continuous care program for four months alongside a cardiac rehab program. control group: patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.
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Main outcome variables
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Quality of life; Functional capacity; re-hospitalization; Depression, Anxiety and Stress
General information
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Reason for update
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During the study, it was necessary to add items in the exclusion criteria that were added to the protocol. The sample size was corrected and the primary and secondary outcomes were edited.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130211012439N3
Registration date:
2019-01-16, 1397/10/26
Registration timing:
prospective
Last update:
2020-09-01, 1399/06/11
Update count:
2
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Registration date
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2019-01-16, 1397/10/26
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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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2019-07-23, 1398/05/01
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Expected recruitment end date
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2020-04-20, 1399/02/01
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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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Comparative evaluation of discharge planning based on continuous care model and routine cardiac rehabilitation on the health related outcomes of patients undergoing coronary artery bypass graft surgery
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Public title
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Comparative evaluation of discharge planning and cardiac rehabilitation on the health outcomes of patients undergoing coronary artery bypass graft surgery
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients after coronary artery bypass graft surgery
The family and patient's willingness to participate in educational programs based on a continuous care model
Close relationship of family member with patient
Exclusion criteria:
Heart Failure class III and IV
Severe musculoskeletal problems
Positive exercise test
did not have access to a smart phone
on medication for psychiatric disorders
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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:
88
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First of all, from patients with coronary artery bypass graft surgery and having inclusion criteria, a sample is selected according to the sampling method and based on balance block randomization method will be placed in cardiac rehabilitation group with education based on continuous care model (intervention) and the cardiac rehabilitation group (control). For this purpose, four sheets of paper are provided by the researcher, writing on two sheets “1” for “first” and on two “2” for second”. The paper sheets will be pooled, placed in a container, and randomly will be drawn one at a time for each patient without replacement until all four sheets are drawn. Then, the four paper sheets will be placed back into the container and this action will be repeated until the sample size is reached.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The cardiac rehabilitation nurse performed the assessments at each time point; she was blinded to random allocation.
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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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This study will take place in two phases of quantitative and qualitative. In the quantitative phase, a clinical trial is conducted and in a qualitative phase, the nested mixed method is conducted through directed content analysis. Patients in the intervention group will be interviewed during the study and the data will be analysed through thematic analysis.
Ethics committees
1
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Ethics committee
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Approval date
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2019-01-05, 1397/10/15
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Ethics committee reference number
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IR.MODARES.REC.1397.183
Health conditions studied
1
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Description of health condition studied
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Patients undergoing coronary artery bypass graft surgery
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ICD-10 code
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I25.1
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ICD-10 code description
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Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
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Description
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Quality of life score in the short form questionnaire 36 questions
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Timepoint
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Before, immediately after and 3 months after the end of the intervention
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Method of measurement
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Short form questionnaire of quality of life
2
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Description
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Measure functional capacity
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Timepoint
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Before, immediately after and 3 months after the end of the intervention
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Method of measurement
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Using a treadmill according to a modified Bruce protocol.
Secondary outcomes
1
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Description
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re-hospitalization
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Timepoint
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Immediately after and 3 months after the end of the intervention
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Method of measurement
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through checking the computer system and directly querying patients (for potential hospitalizations elsewhere).
2
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Description
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Depression score in depression, anxiety and stress questionnaire
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Timepoint
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Before, immediately after and 3 months after the end of the intervention
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Method of measurement
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Depression Anxiety and Stress Scale
3
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Description
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Anxiety score in depression, anxiety and stress questionnaire
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Timepoint
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Before, immediately after and 3 months after the end of the intervention
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Method of measurement
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Depression Anxiety and Stress Scale
4
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Description
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Stress score in depression, anxiety and stress questionnaire
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Timepoint
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Before, immediately after and 3 months after the end of the intervention
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Method of measurement
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Depression Anxiety and Stress Scale
Intervention groups
1
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Description
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Intervention group: after introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form, quality of life questionnaire and Depression, anxiety and stress scale. Also, an exercise test will be done with a treadmill. Then, the Continuous Care Model will be presented to the participants along with cardiac rehabilitation program for four months. The Continuous Care Model consists of four stages: (1) orientation, (2) sensitization, (3) control, and (4) evaluation. At the end of one and four months, quality of life questionnaire and Depression, anxiety, and stress scale will be completed and an exercise test will be done.
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Category
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Rehabilitation
2
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Description
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Intervention control: In this group, patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.
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Category
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Rehabilitation
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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Faculty of Medical Sciences, 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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I must provide all information for the sponsoring institution.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available