Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400628
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-15
Brief Title:
Effectiveness of Chronic Self-management Education on Behavioral and Clinical Outcomes
Sponsor:
Jimma University
Organization:
Jimma University
Study Overview
Official Title:
Effectiveness of Chronic Self-management Education on Behavioral and Clinical Outcomes of Patients With Rheumatic Heart Disease at Jimma Medical Center JMC A Pseudo Quasi Experimental Design
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Design Setting and Period A one-group quasi-experimental study using a pre-test and post-test will be implemented on a convenient sample design to examine the effectiveness of chronic disease self-management education in improving clinical outcomes and decreasing depression and anxiety among patients under medical follow-up at Jimma Medical Center cardiac clinic
A comprehensive evaluation of both clinical and laboratory measurements will be conducted before and after the education intervention Education will be provided monthly four times at 30 60 90 and 120 days with data collection occurring over four months
Sample Size Sampling Technique and Criteria The participants in this study will be patients diagnosed with rheumatic heart disease at Jimma Medical Center cardiac clinic who visit the outpatient department for medical follow-up The study will introduce multi-component nurse-led chronic disease self-management education interventions It will involve a pretest followed by an educational session and a post-test conducted with a one-to-one face-to-face education section The duration of each session will vary between 30 and 45 minutes based on the participants needs
The sample size for the study will be determined using Rao software considering parameters such as a margin of error of 5 a confidence level of 95 a monthly population size of 315 and an unknown response distribution with a conservative estimate of 50 Based on these factors the calculated sample size will be 174 study subjects
Data Analysis Data analysis will be conducted using Statistical Package for the Social Sciences SPSS version 250 Values will be presented as mean standard deviation SD for continuous variables and percentage for categorical variables Continuous data will be compared using a two-tailed Student t-test A p-value of less than 005 will be considered statistically significant for all tests conducted
A comprehensive evaluation of both clinical and laboratory measurements will be conducted before and after the education intervention Education will be provided monthly four times at 30 60 90 and 120 days with data collection occurring over four months
Sample Size Sampling Technique and Criteria The participants in this study will be patients diagnosed with rheumatic heart disease at Jimma Medical Center cardiac clinic who visit the outpatient department for medical follow-up The study will introduce multi-component nurse-led chronic disease self-management education interventions It will involve a pretest followed by an educational session and a post-test conducted with a one-to-one face-to-face education section The duration of each session will vary between 30 and 45 minutes based on the participants needs
The sample size for the study will be determined using Rao software considering parameters such as a margin of error of 5 a confidence level of 95 a monthly population size of 315 and an unknown response distribution with a conservative estimate of 50 Based on these factors the calculated sample size will be 174 study subjects
Data Analysis Data analysis will be conducted using Statistical Package for the Social Sciences SPSS version 250 Values will be presented as mean standard deviation SD for continuous variables and percentage for categorical variables Continuous data will be compared using a two-tailed Student t-test A p-value of less than 005 will be considered statistically significant for all tests conducted
Detailed Description:
Measurements In this study blood samples will be collected from participants using the syringe technique and the samples will be analyzed using a five-differential cellular analysis system machine manufactured by Beckman Coulter in Ireland The machine will generate flags indicating certain abnormalities in the blood parameters To confirm these flags and assess the performance of the automated hematology analyzer a peripheral blood morphology examination will be conducted For this examination a thin blood smear will be prepared from the CBC sample air-dried and then stained with Wright stain Laboratory technologists will carefully examine the stained smear using a 100X oil immersion objective to assess the morphology of red blood cells
To evaluate anxiety and depressive symptoms among patients with rheumatic heart disease RHD the participants will be provided with the Amharic version of the Hospital Anxiety and Depression Scale HADS This scale consists of 14 items which are divided into two subscales one for depression and the other for anxiety Each item on the scale is scored from 0 to 3 with 0 representing the lowest severity and 3 indicating the highest severity of anxiety or depression The scores on the subscales will be summed up to obtain a final score ranging from 0 to 21 Based on the score counts three levels will be established normal 0-7 borderline 8-10 and abnormal 11-21 These levels provide guidance for assessing the severity of anxiety and depression symptoms in the participants
Weight and height will be measured using a combined height and weight scale made in India manufactured on March 17 2017 Weight will be measured to the nearest 01 kg with the participant not wearing shoes and heavy clothes whereas height will be measured to the nearest 01 cm with the participant standing upright with the heel buttock and upper back along the same vertical plane arms at the side and looking straight forward Blood pressure will be measured on the left arm in mmHg using a calibrated sphygmomanometer Yton sphygmomanometer Italy model 10220060 while the participant is in a sitting position with hisher back supported legs uncrossed arm supported and cubital fossa at heart level after 5 minutes of resting arms at the side and looking straight forward
Tools and protocols for chronic disease self-management education The self-management education program includes information about the structure and function of the heart disease risk factors symptoms management prophylaxis penicillinoral antibiotics andor medication compliance nutrition and dietary management as well as maintaining a healthy daily lifestyle The education session will be developed based on heart failure management guidelines produced by the American Heart Failure Society the Joanna Briggs Institutes JBI evidence-based manual and the Ethiopian Ministry of Health All the patients to be enrolled in a series of educational sessions will be led by experienced nurse educators
The contents of the program will be reviewed by experts in cardiology nutrition and public health Face-to-face education methods will be established and the participants will be provided with an educational leaflet with information about RHD heart failure self-reported symptoms and self-care behavior
1 Understanding rheumatic heart disease and self-management of heart failure 1 Introduction Education 2 Knowledge about RHD and heart failure Definition etiology symptoms complications diagnosis and treatment 3 Updating the patients current disease status Medications complications 4 Self-management of heart failure in patients with RHD
- Management of symptoms medication nutrition emotions and daily life
2 Symptoms Monitor the symptoms of patients on a monthly basis and during their unscheduled follow-up visits
Assess the factors that worsen and alleviate the symptoms 2 Verify the use of self-symptom checklists and self-care behavior calendar
Evaluate and implement strategies for managing and retraining Education
1 Symptoms of heart failure measure
2 Signs of heart failure requiring immediate attention assessment
3 Discussion question and answer
3 Prophylaxis and medication Education 1 Importance of Prophylaxis in preventing the recurrence of Acute rheumatic fever and disease severity
Schedule regular follow-up visits Injection site care Common side effect of benzathine penicillin 2 Types of medication effects and side effects 3 Side effects and toxicity of the drug of heart failure 4 Providing information about the medications details and purpose 5 Assessing the challenges and potential adverse reactions associated with the medicationprophylaxis
6 Establish a routine follow-up for consistent medication and prophylaxis usage through the utilization of a self-care behaviors calendar 7 Question and answer 4 Nutrition
1 Education
Dietary considerations for individuals with heart failure
Restrictions on dietary intake of salt fluid
Importance of a balanced diet and meal plan
Important dietary factors to consider for individuals taking warfarin medication
Develop a routine of regularly monitoring weight as frequently as possible
Question and answer 5Routine daily living Education Relaxation stress management Avoid alcohol intake khat chewing and smoking Incorporate a regular physical activity routine by utilizing a self-care behaviors calendar
Question and answer
To evaluate anxiety and depressive symptoms among patients with rheumatic heart disease RHD the participants will be provided with the Amharic version of the Hospital Anxiety and Depression Scale HADS This scale consists of 14 items which are divided into two subscales one for depression and the other for anxiety Each item on the scale is scored from 0 to 3 with 0 representing the lowest severity and 3 indicating the highest severity of anxiety or depression The scores on the subscales will be summed up to obtain a final score ranging from 0 to 21 Based on the score counts three levels will be established normal 0-7 borderline 8-10 and abnormal 11-21 These levels provide guidance for assessing the severity of anxiety and depression symptoms in the participants
Weight and height will be measured using a combined height and weight scale made in India manufactured on March 17 2017 Weight will be measured to the nearest 01 kg with the participant not wearing shoes and heavy clothes whereas height will be measured to the nearest 01 cm with the participant standing upright with the heel buttock and upper back along the same vertical plane arms at the side and looking straight forward Blood pressure will be measured on the left arm in mmHg using a calibrated sphygmomanometer Yton sphygmomanometer Italy model 10220060 while the participant is in a sitting position with hisher back supported legs uncrossed arm supported and cubital fossa at heart level after 5 minutes of resting arms at the side and looking straight forward
Tools and protocols for chronic disease self-management education The self-management education program includes information about the structure and function of the heart disease risk factors symptoms management prophylaxis penicillinoral antibiotics andor medication compliance nutrition and dietary management as well as maintaining a healthy daily lifestyle The education session will be developed based on heart failure management guidelines produced by the American Heart Failure Society the Joanna Briggs Institutes JBI evidence-based manual and the Ethiopian Ministry of Health All the patients to be enrolled in a series of educational sessions will be led by experienced nurse educators
The contents of the program will be reviewed by experts in cardiology nutrition and public health Face-to-face education methods will be established and the participants will be provided with an educational leaflet with information about RHD heart failure self-reported symptoms and self-care behavior
1 Understanding rheumatic heart disease and self-management of heart failure 1 Introduction Education 2 Knowledge about RHD and heart failure Definition etiology symptoms complications diagnosis and treatment 3 Updating the patients current disease status Medications complications 4 Self-management of heart failure in patients with RHD
- Management of symptoms medication nutrition emotions and daily life
2 Symptoms Monitor the symptoms of patients on a monthly basis and during their unscheduled follow-up visits
Assess the factors that worsen and alleviate the symptoms 2 Verify the use of self-symptom checklists and self-care behavior calendar
Evaluate and implement strategies for managing and retraining Education
1 Symptoms of heart failure measure
2 Signs of heart failure requiring immediate attention assessment
3 Discussion question and answer
3 Prophylaxis and medication Education 1 Importance of Prophylaxis in preventing the recurrence of Acute rheumatic fever and disease severity
Schedule regular follow-up visits Injection site care Common side effect of benzathine penicillin 2 Types of medication effects and side effects 3 Side effects and toxicity of the drug of heart failure 4 Providing information about the medications details and purpose 5 Assessing the challenges and potential adverse reactions associated with the medicationprophylaxis
6 Establish a routine follow-up for consistent medication and prophylaxis usage through the utilization of a self-care behaviors calendar 7 Question and answer 4 Nutrition
1 Education
Dietary considerations for individuals with heart failure
Restrictions on dietary intake of salt fluid
Importance of a balanced diet and meal plan
Important dietary factors to consider for individuals taking warfarin medication
Develop a routine of regularly monitoring weight as frequently as possible
Question and answer 5Routine daily living Education Relaxation stress management Avoid alcohol intake khat chewing and smoking Incorporate a regular physical activity routine by utilizing a self-care behaviors calendar
Question and answer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None