Rheumatic FeverNCT06400628
Effectiveness of Chronic Self-management Education on Behavioral and Clinical Outcomes
A study testing Self-management education in people with Rheumatic Fever and Rheumatic Diseases, run by Jimma University at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Rheumatic Fever, Rheumatic Diseases
- What is being tested?
- Self-management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Apr 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 15 years and above with verified diagnosis through echocardiography imaging.
- Patients diagnosed as rheumatic heart disease for at least 6 months by a cardiologist. New York Heart Association (NYHA) function Class II/III.
- Participants who possess the ability to effectively communicate, comprehend the study objectives, and
- Provided consent to participate in the research.
Who cannot join
- Patients under serious medical conditions,
- The existence of chronic illnesses like chronic obstructive pulmonary disease or asthma, diabetes, chronic kidney failure, stroke, or advanced-stage cancer.
Trial locations and contacts
1 site in 1 country.
Hiwot Berhanu Hiwot Berhanu (Assistant professor ), Masters of science (MSC) contact
Andualem Mosse Andualem Mossie Ayana, phd contact
Ethiopia1 site, 1 recruiting
- Recruiting
Jimma university
Jimma, Oromi, 378
Wondu Reta, MSC, wondu.reta@yahoo.com
Danel Geleta, msc, 0911723400, daniel@ju.edu.et
About this study
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
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.
Read more
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 25.0. 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 0.05 will be considered statistically significant for all tests conducted.
Read the 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 0.1 kg with the participant not wearing shoes and heavy clothes, whereas height will be measured to the nearest 0.1 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 his/her 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 (penicillin/oral antibiotics) and/or 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 Institute's (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.
- 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 patient's current disease status Medications, complications 4. Self-management of heart failure in patients with RHD
- Management of symptoms, medication, nutrition, emotions, and daily life
- 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
- Symptoms of heart failure, measure
- Signs of heart failure requiring immediate attention, assessment
- Discussion, question, and answer
- 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 medication's details and purpose. 5. Assessing the challenges and potential adverse reactions associated with the medication/prophylaxis.
- 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
- 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 5.Routine, 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
- Conditions
- Rheumatic Fever, Rheumatic Diseases
- Being tested
- Self-management education
- Medical subject headings
- Rheumatic Fever, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management educationBehavioural
The base line data will be taken and used as control, while the final result will be utilized as the case
| Study group | Role | What they receive |
|---|---|---|
| initial and end | Active comparator | Not described Receives: Behavioral: Self-management education |
| Quasi experimental design | Experimental | quasi Receives: Behavioral: Self-management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-systolic blood pressure, diastolic blood pressure
The effectiveness of the study will be assessed through the measurement of pre and post blood pressure. Blood pressure will be measured using a sphygmomanometer
Measured: Four for months
pre and post weight measurements
weight will be measured using a combined height and weight scale.
Measured: Four four months
Pre- and post- anxiety and depression levels
Pre- and post- anxiety and depression levels using the Hospital Anxiety and Depression scale Questionnaire (HADS)
Measured: Four four months
Pre and post complete blood count
automated hematology analyzer will be used to quantities cells in a person's blood.
Measured: Four four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Apr 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will be randomly selected to be included in the study. Once included, baseline data will be collected from the participants on the date of inclusion, which will serve as the control group or Arm 1 data. Subsequently, all participants will receive an educational intervention, consisting of one-to-one nurse-led multi-component chronic disease self-management education (CDSME), for four consecutive months. During this time, the indicated variables, including blood pressure, pulse rate, weight, and complete blood count, will be measured during monthly visits. Finally, the same variables of the base line variables will be measured from the participants and serve as the second arm (arm2). The study aims to recruit 166 patients with rheumatic heart disease (RHD) from the Jimma Medical Center cardiac clinic.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiwot Berhanu, Jimma University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400628
- Sponsor's protocol ID
- JUIH/IRB/277/23.
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical and RHD indicting laboratory parametric measurements will be measured at initial stage and compared with final measurement results
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06400628
- Acronym / sponsor ID
- JUIH/IRB/277/23.
- Conditions
- Rheumatic Fever, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 25.0. 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 0.05 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 0.1 kg with the participant not wearing shoes and heavy clothes, whereas height will be measured to the nearest 0.1 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 his/her 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 (penicillin/oral antibiotics) and/or 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 Institute's (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.
- 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 patient's current disease status Medications, complications 4. Self-management of heart failure in patients with RHD
- Management of symptoms, medication, nutrition, emotions, and daily life
- 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
- Symptoms of heart failure, measure
- Signs of heart failure requiring immediate attention, assessment
- Discussion, question, and answer
- 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 medication's details and purpose. 5. Assessing the challenges and potential adverse reactions associated with the medication/prophylaxis.
- 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
- 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 5.Routine, 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly selected to be included in the study. Once included, baseline data will be collected from the participants on the date of inclusion, which will serve as the control group or Arm 1 data. Subsequently, all participants will receive an educational intervention, consisting of one-to-one nurse-led multi-component chronic disease self-management education (CDSME), for four consecutive months. During this time, the indicated variables, including blood pressure, pulse rate, weight, and complete blood count, will be measured during monthly visits. Finally, the same variables of the base line variables will be measured from the participants and serve as the second arm (arm2). The study aims to recruit 166 patients with rheumatic heart disease (RHD) from the Jimma Medical Center cardiac clinic.
| Arm | Type | Receives |
|---|---|---|
| initial and end | Active comparator | Behavioral: Self-management education |
| Quasi experimental design | Experimental | Behavioral: Self-management educationquasi |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 15 years and above with verified diagnosis through echocardiography imaging.
- Patients diagnosed as rheumatic heart disease for at least 6 months by a cardiologist. New York Heart Association (NYHA) function Class II/III.
- Participants who possess the ability to effectively communicate, comprehend the study objectives, and
- Provided consent to participate in the research.
Key exclusion criteria (2 listed)
- Patients under serious medical conditions,
- The existence of chronic illnesses like chronic obstructive pulmonary disease or asthma, diabetes, chronic kidney failure, stroke, or advanced-stage cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management educationThe base line data will be taken and used as control, while the final result will be utilized as the case | Behavioural | Quasi experimental design, initial and end |
Primary outcome
Pre- and post-systolic blood pressure, diastolic blood pressure
Time frame: Four for months
The effectiveness of the study will be assessed through the measurement of pre and post blood pressure. Blood pressure will be measured using a sphygmomanometer
pre and post weight measurements
Time frame: Four four months
weight will be measured using a combined height and weight scale.
Pre- and post- anxiety and depression levels
Time frame: Four four months
Pre- and post- anxiety and depression levels using the Hospital Anxiety and Depression scale Questionnaire (HADS)
Pre and post complete blood count
Time frame: Four four months
automated hematology analyzer will be used to quantities cells in a person's blood.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No. Clinical and RHD indicting laboratory parametric measurements will be measured at initial stage and compared with final measurement results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiwot Berhanu Hiwot Berhanu (Assistant professor ), Masters of science (MSC) contact
Andualem Mosse Andualem Mossie Ayana, phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management education in people with Rheumatic Fever and Rheumatic Diseases, run by Jimma University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiwot Berhanu Hiwot Berhanu (Assistant professor ), Masters of science (MSC) (+251(0)917324642, hiwed2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and post-systolic blood pressure, diastolic blood pressure (time frame: Four for months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.