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

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ClinicalTrials.gov Identifier: NCT06045520
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
Ozlem Guzel Polat, Mersin University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nursing Caries Behavioral: Information-Motivation-Behavioral Skills Model Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The research has a randomized controlled interventional study design. An impartial investigator who is not participating in the study will conduct the randomization. Six alternative combinations with a block size of four (ABAB(1), ABBA(2),...) containing codes A and B will be constructed using the block randomization method. From 1 to 6, combinations will be numbered. By sorting the integers (1-6) via randomizer.org 33 times in a random order, a random assignment sequence will be formed. By drawing lots with coins, it will be established which of the A and B codes is the intervention group and which is the control group. Participants who meet the inclusion criteria will be asked to sign an informed consent form, and their group will be shared with the researcher after the pre-tests (T1) are completed. In the intervention group, participants will get a web-based training based on the family-centered approach.
Masking: Single (Participant)
Masking Description: The participants were unaware of which group they were assigned to. The data will be entered using A and B codes, and the researcher doing the statistical analysis will be blind to the participants' groups.
Primary Purpose: Supportive Care
Official Title: Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy: Randomized Controlled Study
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : June 20, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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
No Intervention: Control Group
No intervention was applied to the control group.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045520


Contacts
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Contact: OZLEM GUZEL POLAT, 1 +905067685660 ozlemgzl@mersin.edu.tr
Contact: Ayda ÇELEBİOĞLU, 2 +905332525049 aydozan@hotmail.com

Locations
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Turkey
Mersin University Recruiting
Mersin, Turkey, 33343
Contact: Ozlem Guzel Polat, 1    +905067685660    ozlemgzl@mersin.edu.tr   
Contact: Ayda Çelebioğlu, 2       aydozan@hotmail.com   
Sponsors and Collaborators
Mersin University
Investigators
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Study Director: Ayda Çelebioğlu Mersin University
More Information
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Publications:

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Responsible Party: Ozlem Guzel Polat, PhD (c), Nursing, Mersin University
ClinicalTrials.gov Identifier: NCT06045520    
Other Study ID Numbers: MersinU-HB-OGP-02
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: February 14, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozlem Guzel Polat, Mersin University:
adolescent
epilepsy
education training
pediatric nursing
Information-Motivation-Behavioral Skills Model
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases