Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy

February 13, 2024 updated by: Ozlem Guzel Polat, Mersin University

Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy: Randomized Controlled Study

The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. It is aimed to find a statistically significant difference from the scales (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) at the end of the training of adolescents who received an 8-week training program.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Hypotheses H1: There is a difference between the seizure self-efficacy scale scores of the intervention group based on the IMB model and the control group.

H2: There is a difference between perceived social support of scale scores of the intervention group based on the IMB model and the control group.

H3: There is a difference between child attitude towards illness scale scores of the intervention group based on the IMB model and the control group.

H4: There is a difference between knowledge test for epilepsy disease scale scores of the intervention group based on the IMB model and the control group.

Epilepsy is the most common neurological disease in childhood. Due to the diagnosis in childhood, parents take a more active role in disease management, while the child remains more passive in this process. In this period, the burden of adaptation of the parents to the treatment passes to the adolescent who is in the process of transition from childhood to adulthood. The adolescent's search for self-discovery and identity in physical, psychosocial, cognitive and emotional areas may become more complex with epilepsy disease management. The adolescent's burden of treatment compliance may lead to poor adherence to the disease and worsen short- and long-term health outcomes. Disease self-management in epilepsy represents the processes required for disease knowledge, seizure control, medication adherence, increasing social support and quality of life, and reducing the negative effects of the disease. Adolescents have low personal motivation for disease management and therefore need more social support from parents and peers. Educational training implemented in this period have an effect that increases motivation to gain skills to adapt to the disease. Fisher et al. developed the IBM model in order to develop health behaviour for HIV prevention in adolescents. This model argues that knowledge is a basis for behaviour change, but it is not sufficient alone. However, it is argued that people will have the necessary behavioural skills when they are well informed and motivated for effective action. In the studies conducted, it was determined that the fact that the model was simple, understandable, low cost and clearly defined implementation stages supported adolescents to develop health behaviour skills. When the international and national literature was examined, no training based on the Knowledge Motivation Behaviour model for adolescents with epilepsy was found. The fact that the model is simple, understandable, low cost and clearly defined implementation stages will support the disease management of adolescents. It is thought that adolescents who are well informed and well motivated with the training based on the Knowledge Motivation Behaviour model and who have developed behavioural skills with training can support disease management.

IMPLEMENTATION OF RESEARCH

Data will be collected in the pediatric neurology department of a university hospital in the Mediterranean region of southern Turkey. Patients and their parents who meet the inclusion criteria will be informed about the study and the education training. Verbal consent will be obtained by the researcher from the patient who agrees to participate in the study. Pre-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Level of Social Support Scale, Child's Attitude Towards His/her Disease Scale) will be applied. After the forms are administered, the assignment sequence, registration of the participants and patients will be assigned to the intervention or control groups by an independent researcher.

Written informed consent will then be obtained from patients assigned to the intervention and control groups and their parents. Adolescents with epilepsy in the intervention group will receive an 8-session educational training. Each session will be limited to 10-12 adolescents and the intervention group will be divided into three groups of 11. Each session of the training will be limited to 40-50 minutes. The researchers are working as a lecturer in the departments of pediatric health and diseases nursing and pediatric neurology and as a specialist nurse with a total of 14 years of experience in the neonatal intensive care unit and paediatric health and diseases service. Sessions will be held with the participation of at least one of the researchers.

Sessions will be held with the participation of at least one researcher. The training program was developed by researchers and program development specialists. Within the scope of the research, a separate session on seizure management will be held for an individual requested by the adolescents in order to increase the social support level of the adolescents. Post-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Own Illness Scale) were administered to the adolescents in the intervention group immediately after completing the 8-session training program and one month later (twice in total). Towards Attitude Scale) will be applied again.

Informed written consent forms will be obtained from the adolescents in the control group and their parents immediately after they accept the research, and pre-test forms (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Attitude Towards His Own Illness Scale. ) will be applied. After the pre-test forms are applied, no intervention will be applied to the control group. .

Adolescents in the control group will not receive any intervention other than standard care and routine monitoring provided by the doctor and nurse at the outpatient clinic. Immediately after the training program given to the adolescents in the intervention group was completed and one month later (twice in total), post-test forms were administered to the control group (Epilepsy Knowledge Test for Adolescents, Seizure Self-Efficacy Status Scale in Children with Epilepsy, Multidimensional Perceived Social Support Level Scale, Child's Self-Efficacy Scale). Attitude Towards Illness Scale) will be administered again.

After the data collection phase, after the analysis of the data and determining that the training program is effective, the training program will be applied to the control group without any changes in the training program given to the intervention group.

STATISTICAL

A statistical package program will be used in the analysis of the data. The conformity of the mean scores of the scale to the normal distribution will be evaluated with the coefficients of kurtosis and skewness, and the means will be compared with parametric or nonparametric test techniques. The similarity of the groups in terms of demographic and clinical characteristics will be evaluated with the relevant tests. Cohen's d effect size will be calculated to express the size of the difference between the means.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For adolescents;

  • Those who agree to participate in the study and sign the Informed Voluntary Consent Form
  • Age between 12-18 years
  • Diagnosis of epilepsy
  • No communication barriers (visual, hearing, mental retardation)
  • No other chronic disease other than epilepsy
  • Being literacy

Exclusion Criteria:

For adolescents;

  • Refusal to participate in the study
  • Those who do not sign the Informed Volunteer Consent Form
  • Those who do not sign the Informed Volunteer Consent Form
  • Under 12 years old, over 18 years old,
  • No diagnosis of epilepsy
  • Communication disability (visual, hearing, mental retardation)
  • No another chronic disease other than epilepsy
  • Illiteracy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
No intervention was applied to the control group.
Experimental: IBM Educational Training
Intervention group participants will receive IBM skills model on educational training intervention for 8 weeks.
Behavioral: Information-Motivation-Behavioral Skills Model
1.-2.Meeting:Regarding the information component of the IMB model; Answers given by the adolescents to the epilepsy knowledge test, the topics on which the adolescent wants to get information will be agreed with the adolescent and an education training will be created.3.,4.,5.-6. Meeting:Personal motivation, which is the first step of the motivation component; A meeting will be held regarding the obstacles to the disease, attitudes and behaviors towards the disease. In order to strengthen social support systems, a one-session seizure management training will be planned with a person chosen by the adolescent from his parent or friend group.7-8. Meeting:Seizure self-efficacy and treatment compliance will be evaluated in the behavioral skills component. During training, achievable goals will be set to ask the adolescent to provide personal feedback, ask open-ended questions, engage in reflective listening, and increase personal and social motivation to comply with medical recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the mean score of adolescents in the epilepsy disease knowledge test
Time Frame: an average of 3 month
The "epilepsy knowledge test for adolescents" developed by the researchers consists of 25 items. The knowledge test includes true and false items. The items were evaluated with item prop. correct and item discrimination index ITEMAN analysis. The reliability coefficient, which provides evidence of the internal consistency of the knowledge test, was found to be KR-20 (Kuder-Richardson) = 0.813.
an average of 3 month
Change in the mean score of adolescents in the Seizure Self-Efficacy Scale in Children with Epilepsy
Time Frame: an average of 3 month
The scale, which was developed by Caplin et al. and whose Turkish validity and reliability study was conducted by Güven and İşler in 2015, is a 15-item 5-point Likert-type scale. It was conducted with children aged 9-18 years with epilepsy and the cronbach alpha value was found to be 0.89. The scale is a 15-item five-point Likert-type scale and the scale items are scored between 1-5. A high score on the scale is interpreted as an improved seizure self-efficacy of the child
an average of 3 month
Change in the mean score of adolescents in the Multidimensional Perceived Social Support Scale
Time Frame: an average of 3 month
The Multidimensional Perceived Social Support Scale was developed by Zimet et al. The Cronbach's alpha coefficient of the scale, whose validity and reliability study was performed by Eker et al. in 2001, was found to be 0.80-0.95. The scale consists of 12 items and evaluates social support received from three different sources. The scale consists of a 7-point Likert scale as "Absolutely no 1,2,3,4,5,5,6,7 Absolutely yes". The scale has a total of three sub-dimensions as family (mother, father, spouse, children and siblings), friend and special person support (dating, oral, fiancé, neighbour, relative, doctor) and each sub-dimension consists of 4 items. The sub-dimension scores are obtained by summing the four items in the sub-dimensions, and the total score is obtained by summing all sub-dimensions. A minimum score of 12 points and a maximum score of 84 points can be obtained from the scale. A high total score indicates a high level of perceived social support
an average of 3 month
Change in the mean score of adolescents in theChild's Attitude Towards His Own Illness Scale
Time Frame: an average of 3 month
The Turkish validity and reliability study of the scale developed by Austin and Huberty was conducted by Ersun and Bolışık. The scale, whose Cronbach Alpha value is 0.79, is a 5-point Likert type and consists of 15 items. The original scale was developed for children aged 8-12 with chronic diseases. However, in a systematic review of the scale, it was stated that it could be used safely between the ages of 8 and 22. 4 of the 13 items are bipolar adjectives (Very Good, Somewhat Good, Not Sure, Somewhat Bad, Very Bad) and 9 are from options expressing how often they experience the positive and negative aspects of having a chronic disease (Very Often, Often, Sometimes , Not Often, Never). Among the scale items scored between 1 and 5, 1 and 2 indicate negative attitude, 3 indicate neutral attitude, and 4 and 5 indicate positive attitude.
an average of 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Investigators

  • Study Director: Ayda Çelebioğlu, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

June 20, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MersinU-HB-OGP-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nursing Caries

Clinical Trials on Information-Motivation-Behavioral Skills Model

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe