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

NCT06400628 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-05-06

No results posted yet for this study

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 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.

Conditions

  • Rheumatic Fever
  • Rheumatic Diseases

Interventions

BEHAVIORAL

Self-management education

The base line data will be taken and used as control, while the final result will be utilized as the case

Sponsors & Collaborators

  • Jimma University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-07-31
Completion
2024-08-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400628 on ClinicalTrials.gov