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Status unknownNCT06400628Updated May 6, 2024

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

An interventional study of Self-management education in Rheumatic Fever and Rheumatic Diseases, sponsored by Jimma University. Status unknown at 1 site in Ethiopia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Jimma University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

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.

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.

  1. 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

  2. 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

      1. Symptoms of heart failure, measure
      2. Signs of heart failure requiring immediate attention, assessment
      3. Discussion, question, and answer
  3. 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.

      6. 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

      1. 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

02

Conditions studied

  • Rheumatic Fever
  • Rheumatic Diseases
03

In context

Rheumatic Fever

64 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.

This study's planned enrollment of 166 is above the median of 80 across 29 interventional studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

Jimma University is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
166 participants (estimated)

Study arms

  • Active comparator
    initial and end

    Behavioral: Self-management education

  • Experimental
    Quasi experimental design

    quasi

    Behavioral: Self-management education

Interventions

  • BehavioralSelf-management education

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Four for months

  2. pre and post weight measurements

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

    Time frame: Four four months

  3. Pre- and post- anxiety and depression levels

    Pre- and post- anxiety and depression levels using the Hospital Anxiety and Depression scale Questionnaire (HADS)

    Time frame: Four four months

  4. Pre and post complete blood count

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

    Time frame: Four four months

07

Study locations

1 of 1 sites recruiting
  • Jimma university
    Jimma, Oromi 378, Ethiopia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Clinical and RHD indicting laboratory parametric measurements will be measured at initial stage and compared with final measurement results

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2024 (actual). Primary completion is estimated for Jul 2024, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2024
First posted
May 6, 2024
StartActual
Apr 1, 2024
Primary completionEst.
Jul 31, 2024
CompletionEst.
Aug 31, 2024
Last update
May 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06400628
Lead sponsor
Jimma University
Responsible party
Hiwot Berhanu (Assistant professor, Jimma University) — Principal investigator
First posted
May 6, 2024
Start date
Apr 1, 2024
Primary completion
Jul 31, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
May 6, 2024

Study contacts

Hiwot Berhanu Hiwot Berhanu (Assistant professor ), Masters of science (MSC)
Contact
hiwed2010@gmail.com
+251(0)917324642
Andualem Mosse Andualem Mossie Ayana, phd
Contact
andualemm2000@gmail.com
+251966764380 ext. +251(0)9173246

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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