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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Protocol summary
This study is conducted as a combined embedded study. The quantitative part of the study of the clinical trial type and 86 patients undergoing coronary artery bypass graft surgery were assigned in two groups (intervention and control) by random block method.
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.
This study is conducted as a combined embedded study. The quantitative part of the study of the clinical trial type and 8688 patients undergoing coronary artery bypass graft surgery were assigned in two groups (intervention and control) by random block method.
این مطالعه به صورت ترکیبی ادغام شده انجام می شود. بخش کمی مطالعه از نوع کارآزمایی بالینی می باشد که 86 بیمار تحت عمل جراحی پیوند عروق کرونر در دو گروه (مداخله و کنترل) به روش بلوکهای تصادفی تخصیص داده می شوند.
این مطالعه به صورت ترکیبی ادغام شده انجام می شود. بخش کمی مطالعه از نوع کارآزمایی بالینی می باشد که 88 بیمار تحت عمل جراحی پیوند عروق کرونر در دو گروه (مداخله و کنترل) به روش بلوکهای تصادفی تخصیص داده می شوند.
این مطالعه به صورت ترکیبی ادغام شده انجام می شود. بخش کمی مطالعه از نوع کارآزمایی بالینی می باشد که 8688 بیمار تحت عمل جراحی پیوند عروق کرونر در دو گروه (مداخله و کنترل) به روش بلوکهای تصادفی تخصیص داده می شوند.
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.
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.
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.
معیارهای ورود: بیماران پس از پیوند عروق کرونری; تمایل به شرکت در مطالعه; نسبت درجه یک عضو خانواده با بیمار. معیارهای عدم ورود: نارسایی قلبی کلاس 3 و 4; تست ورزش مثبت; مشکلات شدید عضلانی اسکلتی.
معیارهای ورود: بیماران پس از پیوند عروق کرونری; تمایل به شرکت در مطالعه; نسبت درجه یک عضو خانواده با بیمار. معیارهای عدم ورود: نارسایی قلبی کلاس 3 و 4; تست ورزش مثبت; مشکلات شدید عضلانی اسکلتی; عدم دسترسی به تلفن هوشمند; تحت درمان دارویی برای اختلال روانی.
معیارهای ورود: بیماران پس از پیوند عروق کرونری; تمایل به شرکت در مطالعه; نسبت درجه یک عضو خانواده با بیمار. معیارهای عدم ورود: نارسایی قلبی کلاس 3 و 4; تست ورزش مثبت; مشکلات شدید عضلانی اسکلتی; عدم دسترسی به تلفن هوشمند; تحت درمان دارویی برای اختلال روانی.
Quality of life; Depression, Anxiety and Stress; Readmission
Quality of life; Functional capacity; re-hospitalization; Depression, Anxiety and Stress
Quality of life; Functional capacity; re-hospitalization; Depression, Anxiety and Stress; Readmission
کیفیت زندگی؛ افسردگی، اضطراب و استرس؛ بستری مجدد
کیفیت زندگی؛ ظرفیت عملکردی؛ بستری مجدد؛ افسردگی، اضطراب و استرس
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.
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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در حین انجام مطالعه نیاز به اضافه کردن مواردی در معیار خروج بود که به پروتکل اضافه شد. حجم نمونه اصلاح شد و پیامدهای اولیه و ثانویه ویرایش شد.
در حین انجام مطالعه نیاز به اضافه کردن مواردی در معیار خروج بود که به پروتکل اضافه شد. حجم نمونه اصلاح شد و پیامدهای اولیه و ثانویه ویرایش شد.
Heart Failure class III and IV
Severe musculoskeletal problems
Positive exercise test
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
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
نارسایی قلبی کلاس 3 و 4
مشکلات شدید عضلانی اسکلتی
تست ورزش مثبت
عدم دسترسی به تلفن هوشمند
تحت درمان دارویی برای اختلالات روانی
نارسایی قلبی کلاس 3 و 4 مشکلات شدید عضلانی اسکلتی تست ورزش مثبت عدم دسترسی به تلفن هوشمند تحت درمان دارویی برای اختلالات روانی
The cardiac rehabilitation nurse performed the assessments at each time point; she was blinded to random allocation.
The cardiac rehabilitation nurse performed the assessments at each time point; she was blinded to random allocation.
پرستار توانبخشی قلب ارزیابی ها را در هر مرحله انجام داد. او از تخصیص تصادفی کورسازی شده بود.
پرستار توانبخشی قلب ارزیابی ها را در هر مرحله انجام داد. او از تخصیص تصادفی کورسازی شده بود.
Primary outcomes
#1
Stress score in depression, anxiety and stress questionnaire
Measure functional capacity
Stress score in depression, anxiety and stress questionnaireMeasure functional capacity
نمره استرس در پرسشنامه افسردگی، اضطراب و استرس
اندازه گیری ظرفیت عملکردی
نمره استرس در پرسشنامه افسردگی، اضطراب و استرساندازه گیری ظرفیت عملکردی
Depression Anxiety and Stress Scale
Using a treadmill according to a modified Bruce protocol.
Depression Anxiety and Stress ScaleUsing a treadmill according to a modified Bruce protocol.
مقیاس افسردگی، اضطراب و استرس
با استفاده از تردمیل طبق پروتکل تعدیل شده بروس
مقیاس افسردگی، اضطراب و استرسبا استفاده از تردمیل طبق پروتکل تعدیل شده بروس
#2
Depression score in depression, anxiety and stress questionnaire
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Depression score in depression, anxiety and stress questionnaire
نمره افسردگی در پرسشنامه افسردگی، اضطراب و استرس
empty
نمره افسردگی در پرسشنامه افسردگی، اضطراب و استرس
Before, immediately after and 3 months after the end of the intervention
empty
Before, immediately after and 3 months after the end of the intervention
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
empty
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
Depression Anxiety and Stress Scale
empty
Depression Anxiety and Stress Scale
مقیاس افسردگی، اضطراب و استرس
empty
مقیاس افسردگی، اضطراب و استرس
#3
Anxiety score in depression, anxiety and stress questionnaire
empty
Anxiety score in depression, anxiety and stress questionnaire
نمره اضطراب در پرسشنامه افسردگی، اضطراب و استرس
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نمره اضطراب در پرسشنامه افسردگی، اضطراب و استرس
Before, immediately after and 3 months after the end of the intervention
empty
Before, immediately after and 3 months after the end of the intervention
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
empty
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
Depression Anxiety and Stress Scale
empty
Depression Anxiety and Stress Scale
مقیاس افسردگی، اضطراب و استرس
empty
مقیاس افسردگی، اضطراب و استرس
Secondary outcomes
#1
Readmission
re-hospitalization
Readmissionre-hospitalization
By appointment and phone call with the patient
through checking the computer system and directly querying patients (for potential hospitalizations elsewhere).
By appointmentthrough checking the computer system and phone call with the patientdirectly querying patients (for potential hospitalizations elsewhere).
از طریق ملاقات حضوری و تماس تلفنی با بیمار
از طریق بررسی سیستم رایانه ای و پرس و جو مستقیم از بیماران (برای بستری شدن بالقوه در جای دیگر).
از طریق ملاقات حضوریبررسی سیستم رایانه ای و تماس تلفنی با بیمارپرس و جو مستقیم از بیماران (برای بستری شدن بالقوه در جای دیگر).
#2
empty
Depression score in depression, anxiety and stress questionnaire
Depression score in depression, anxiety and stress questionnaire
empty
نمره افسردگی در پرسشنامه افسردگی، اضطراب و استرس
نمره افسردگی در پرسشنامه افسردگی، اضطراب و استرس
empty
Before, immediately after and 3 months after the end of the intervention
Before, immediately after and 3 months after the end of the intervention
empty
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
empty
Depression Anxiety and Stress Scale
Depression Anxiety and Stress Scale
empty
مقیاس افسردگی، اضطراب و استرس
مقیاس افسردگی، اضطراب و استرس
#3
empty
Anxiety score in depression, anxiety and stress questionnaire
Anxiety score in depression, anxiety and stress questionnaire
empty
نمره اضطراب در پرسشنامه افسردگی، اضطراب و استرس
نمره اضطراب در پرسشنامه افسردگی، اضطراب و استرس
empty
Before, immediately after and 3 months after the end of the intervention
Before, immediately after and 3 months after the end of the intervention
empty
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
empty
Depression Anxiety and Stress Scale
Depression Anxiety and Stress Scale
empty
مقیاس افسردگی، اضطراب و استرس
مقیاس افسردگی، اضطراب و استرس
#4
empty
Stress score in depression, anxiety and stress questionnaire
Stress score in depression, anxiety and stress questionnaire
empty
نمره استرس در پرسشنامه افسردگی، اضطراب و استرس
نمره استرس در پرسشنامه افسردگی، اضطراب و استرس
empty
Before, immediately after and 3 months after the end of the intervention
Before, immediately after and 3 months after the end of the intervention
empty
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
قبل، بلافاصله بعد و 3 ماه بعد از اتمام مداخله
empty
Depression Anxiety and Stress Scale
Depression Anxiety and Stress Scale
empty
مقیاس افسردگی، اضطراب و استرس
مقیاس افسردگی، اضطراب و استرس
Intervention groups
#1
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. 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.
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.
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.
گروه مداخله: پس از معرفی مطالعه و بیان اهداف آن، بیماران فرم رضایت آگاهانه، فرم اطلاعات دموگرافیک، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس را کامل خواهند کرد. سپس به مدت چهار ماه "مدل مراقبت پیگیر" در کنار برنامه بازتوانی قلبی اجرا خواهد شد. این مدل شامل 4 مرحله یعنی آشناسازی سازی، حساس سازی، کنترل و ارزشیابی است. در پایان دوره یک و چهار ماهه، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس توسط این گروه کامل خواهد گردید.
گروه مداخله: پس از معرفی مطالعه و بیان اهداف آن، بیماران فرم رضایت آگاهانه، فرم اطلاعات دموگرافیک، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس را کامل خواهند کرد. همچنین تست ورزش با تردمیل انجام خواهد شد. سپس به مدت چهار ماه "مدل مراقبت پیگیر" در کنار برنامه بازتوانی قلبی اجرا خواهد شد. این مدل شامل 4 مرحله یعنی آشناسازی سازی، حساس سازی، کنترل و ارزشیابی است. در پایان دوره یک و چهار ماهه، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس توسط این گروه کامل خواهد گردید. و تست ورزش انجام خواهد شد.
گروه مداخله: پس از معرفی مطالعه و بیان اهداف آن، بیماران فرم رضایت آگاهانه، فرم اطلاعات دموگرافیک، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس را کامل خواهند کرد. همچنین تست ورزش با تردمیل انجام خواهد شد. سپس به مدت چهار ماه "مدل مراقبت پیگیر" در کنار برنامه بازتوانی قلبی اجرا خواهد شد. این مدل شامل 4 مرحله یعنی آشناسازی سازی، حساس سازی، کنترل و ارزشیابی است. در پایان دوره یک و چهار ماهه، پرسشنامه کیفیت زندگی و مقیاس افسردگی، اضطراب و استرس توسط این گروه کامل خواهد گردید. و تست ورزش انجام خواهد شد.
Protocol summary
Study aim
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
Design
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.
Settings and conduct
This study will be carried out in Farshchian Cardiac center, affiliated to the Hamadan University of Medical Sciences in Hamadan.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Quality of life; Functional capacity; re-hospitalization; Depression, Anxiety and Stress
General information
Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Fatemeh Pakrad
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4041
Email address
f_pakrad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparative evaluation of discharge planning and cardiac rehabilitation on the health outcomes of patients undergoing coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
The cardiac rehabilitation nurse performed the assessments at each time point; she was blinded to random allocation.
Placebo
Not used
Assignment
Parallel
Other design features
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.
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way
City
Tehran
Province
Tehran
Postal code
14115-333
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.MODARES.REC.1397.183
Health conditions studied
1
Description of health condition studied
Patients undergoing coronary artery bypass graft surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Quality of life score in the short form questionnaire 36 questions
Timepoint
Before, immediately after and 3 months after the end of the intervention
Method of measurement
Short form questionnaire of quality of life
2
Description
Measure functional capacity
Timepoint
Before, immediately after and 3 months after the end of the intervention
Method of measurement
Using a treadmill according to a modified Bruce protocol.
Secondary outcomes
1
Description
re-hospitalization
Timepoint
Immediately after and 3 months after the end of the intervention
Method of measurement
through checking the computer system and directly querying patients (for potential hospitalizations elsewhere).
2
Description
Depression score in depression, anxiety and stress questionnaire
Timepoint
Before, immediately after and 3 months after the end of the intervention
Method of measurement
Depression Anxiety and Stress Scale
3
Description
Anxiety score in depression, anxiety and stress questionnaire
Timepoint
Before, immediately after and 3 months after the end of the intervention
Method of measurement
Depression Anxiety and Stress Scale
4
Description
Stress score in depression, anxiety and stress questionnaire
Timepoint
Before, immediately after and 3 months after the end of the intervention
Method of measurement
Depression Anxiety and Stress Scale
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian cardiac center
Full name of responsible person
Fatemeh Pakrad
Street address
Shahid Fahmidah Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
f.pakrad@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University