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

NCT06400628 | Recruiting DMC

• 1 other identifier: JUIH/IRB/277/23.
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• 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

• pre and post weight measurements

  weight will be measured using a combined height and weight scale.

  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)

  Four four months

• Pre and post complete blood count

  automated hematology analyzer will be used to quantities cells in a person's blood.

  Four four months

Study Arms (2)

initial and end

ACTIVE COMPARATOR

Behavioral: Self-management education

Quasi experimental design

EXPERIMENTAL

quasi

Behavioral: Self-management education

Interventions

Self-management education BEHAVIORAL

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

Quasi experimental design; initial and end

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Jimma university

Jimma, Oromi, 378, Ethiopia

RECRUITING

MeSH Terms

Conditions

Rheumatic Fever; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hiwot Berhanu Hiwot Berhanu (Assistant professor ), Masters of science (MSC)

CONTACT

+251(0)917324642; hiwed2010@gmail.com

Andualem Mosse Andualem Mossie Ayana, phd

CONTACT

+251966764380; andualemm2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: participants and investigator were informed about the expected outcomes. However, care providers and outcome assessor were masked to overcome any associated bias
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 6, 2024
• Study Start: April 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)