Investigating the effect of education based on continuous care model on quality of life, quality of sleep and fatigue in patients undergoing coronary artery bypass surgery.
The impact of education based on continuous care model on quality of life, sleep quality and fatigue in patients undergoing coronary artery bypass surgery
Design
The clinical trial has two intervention and control groups, with parallel groups, unblinded study, non-random assignment to test and control groups, no study phase, sample size 140 patients
Settings and conduct
The current study is a before and after trial that will be conducted in the rehabilitation clinic of the Rehabilitation Research Center on 140 patients undergoing coronary artery bypass surgery in the Cardiology Research Institute.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- People who have had at least 2 months of coronary artery bypass grafting (CABG) and have been admitted to Chamran Hospital and have a hospital record
2- Consent to participate in the study
3- Having reading and writing literacy
4- Internet access
5- The ability to use virtual space to participate in web meetings and to use programs such as Skyroom
6- Resident of Isfahan
Not inclusion criteria:
1- Prohibition of physical activity as determined by the physician
2- Having a special diet recommended by the physician
3- Having other disabilities such as blindness, deafness and mental retardation
4- Suffering from neurological, cerebro-vascular, psychiatric, urinary-genital disorders, being treated with psychiatric drugs (due to non-cardiac diseases) based on the patient's record
Intervention groups
Intervention group: The duration of the continuous care model is 12 weeks, which is done during a familiarization phase and 6 sensitization sessions in a period of four weeks and two control and evaluation stages by questionnaire.
Control group: Only familiarization phase will be held to this group
Main outcome variables
Quality of life, quality of sleep and fatigue in patients undergoing coronary artery transplantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230219057454N1
Registration date:2023-03-02, 1401/12/11
Registration timing:prospective
Last update:2023-03-02, 1401/12/11
Update count:0
Registration date
2023-03-02, 1401/12/11
Registrant information
Name
Hossein Shahnazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3243
Email address
h_shahnazi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on continuous care model on quality of life, quality of sleep and fatigue in patients undergoing coronary artery bypass surgery.
Public title
Investigating the effect of training on quality of life, quality of sleep and fatigue in cardiac patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People who have had at least 2 months of coronary artery bypass grafting (CABG) and have been admitted to Chamran Hospital and have a hospital record
Consent to participate in the study
Having reading and writing literacy
Internet access
The ability to use virtual space to participate in web meetings and to use programs such as Skyroom
Resident of Isfahan
Exclusion criteria:
Prohibition of physical activity as determined by the physician
Having a special diet recommended by the physician
Having other disabilities such as blindness, deafness and mental retardation
Suffering from neurological, cerebro-vascular, psychiatric, urinary-genital disorders, being treated with psychiatric drugs (due to non-cardiac diseases) based on the patient's record
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Ave, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.371
Health conditions studied
1
Description of health condition studied
Quality of life, quality of sleep and fatigue
ICD-10 code
ICD-10 code description
Acute myocardial infarction, unspecified
Primary outcomes
1
Description
Fatigue score in Chalder's Fatigue Questionnaire
Timepoint
Completing the fatigue questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase)
Method of measurement
Chalder fatigue questionnaire
2
Description
Sleep quality score in the Pittsburgh Sleep Quality Questionnaire
Timepoint
Completing the sleep quality questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase)
Method of measurement
Pittsburgh sleep quality questionnaire
3
Description
Quality of life score in the MًَacNew quality of life questionnaire
Timepoint
Completing the quality of life questionnaire form before the intervention (familiarization phase) and at the end of the first month and the end of the second month after the intervention (evaluation phase)
Method of measurement
MacNew Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Description of the intervention in the intervention group: The stages of this model are: familiarization, sensitization, control and evaluation. The duration of the implementation of the continuous care model is 12 weeks, which includes a familiarization phase and 6 sensitization sessions in a period of four weeks and two control phases, and the evaluation is done by a questionnaire. The connected and coherent stages of the continuous care model are: Familiarization stage: The actions of this stage include introducing the trainer to the patient and family, clarifying the trainer's expectations in the study stages, specifying the patient's and his family's expectations and expectations, completing ethical consideration forms, Completing the questionnaire forms after selecting and accepting the patient and family through the press line, determining and agreeing on the time of training sessions, by phone and mentioning the goals and how to communicate, this step is done for both intervention and control groups. Sensitization stage: The actions of this stage include examining the situation and explaining the skill training needs of the patient and the family, explaining about the disease and the existing and possible resulting complications, examining the basic needs regarding the quality of life, sleep quality, fatigue and justifying the need to pay attention to it, explaining The problems are caused by the complications of the disease and addressing the desired questions and answers with an emphasis on the risk factors. Familiarization and sensitization stages will be held in the first 4 weeks of the implementation of the model in 6 sessions of 30 to 45 minutes according to the level of tolerance and acceptance of the patients. At this stage, the quality of life, sleep quality and fatigue questionnaires are completed by the patients of the intervention group .Control phase: The actions of this phase include direct and indirect evaluation of acquired skills, checking the stability of health behaviors, checking new needs with regard to new problems and re-sensitizing regarding problem solving, strengthening health behaviors and justifying the beneficial effects of actions with regard to improving the index. tangible things, controlling the studied variables, exchanging opinions about the success and failure of the measures taken, explaining the proposed solution with the help of the patient and family. In this stage, follow-up care consultations will be carried out frequently for two months with phone calls according to the care needs of the intervention group. Evaluation stage: The actions of this stage include the evaluation of the desired variables using questionnaires. Finally, this stage ends with completing the questionnaire at the end of the first month and the end of the second month after the intervention.
Category
Lifestyle
2
Description
Control group: : Familiarization stage: The first step in the continuous care model is familiarization, the purpose of which is mutual recognition (patient, family and teacher) and explanation of the model stages. The actions of this stage include introducing the trainer to the patient and the family, clarifying the trainer's expectations during the study stages, specifying the expectations and expectations of the patient and his family, completing the ethical consideration forms, completing the questionnaire forms after selecting and accepting the patient and the family through the press line. Determining and agreeing on the time of the training sessions, on the phone, and mentioning the goals and how the communication is possible which this process is done in the control stage.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart and Vascular Hospital
Full name of responsible person
Atefeh Ghanavatpour
Street address
Chamran Hospital, Third Mushtaq St., Bozorgmehr Bridge, Isfahan Province, Iran