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Effectiveness of Chronic Self-management Education on Behavioral and Clinical Outcomes

Sponsored by Jimma University

About this trial

Last updated 2 years ago

Study ID

JUIH/IRB/277/23.

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

15+ Years
All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the Participation Requirements?

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.