Rheumatic Diseases Clinical Trial
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. 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.
Status | Recruiting |
Enrollment | 166 |
Est. completion date | August 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: Inclusion criteria - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Jimma university | Jimma | Oromi |
Lead Sponsor | Collaborator |
---|---|
Jimma University |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Four for months | |
Primary | pre and post weight measurements | weight will be measured using a combined height and weight scale. | Four four months | |
Primary | Pre- and post- anxiety and depression levels | Pre- and post- anxiety and depression levels using the Hospital Anxiety and Depression scale Questionnaire (HADS) | Four four months | |
Primary | Pre and post complete blood count | automated hematology analyzer will be used to quantities cells in a person's blood. | Four four months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT04042792 -
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
|
||
Recruiting |
NCT05554029 -
Coronaphobia in Rheumatic Diseases
|
N/A | |
Completed |
NCT02944448 -
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
|
Phase 2 | |
Completed |
NCT02694796 -
Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy
|
N/A | |
Completed |
NCT02256098 -
RSA RCT: ATTUNEā¢ TKA Versus PFC Sigma TKA
|
N/A | |
Completed |
NCT02269254 -
Persona Versus NexGen
|
N/A | |
Completed |
NCT00642837 -
A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets
|
Phase 4 | |
Active, not recruiting |
NCT04704544 -
Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE)
|
N/A | |
Completed |
NCT05026853 -
Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
|
N/A | |
Active, not recruiting |
NCT04631965 -
Healthcare Transition of Adolescents With Chronic Health Conditions
|
||
Recruiting |
NCT00024479 -
Natural History of Rheumatic Diseases in Minority Communities
|
||
Completed |
NCT05031104 -
Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis
|
N/A | |
Not yet recruiting |
NCT04567576 -
Predictive Factors for COVID-19 in Rheumatology
|
||
Completed |
NCT02291471 -
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
|
Phase 1 | |
Completed |
NCT01227694 -
Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT01071447 -
Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment
|
N/A | |
Active, not recruiting |
NCT05618782 -
Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee
|
Phase 2 | |
Active, not recruiting |
NCT05543642 -
The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)
|
Phase 4 | |
Active, not recruiting |
NCT02694185 -
Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications
|
N/A |