Nursing CariesNCT06045520
Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy
A study testing Information-Motivation-Behavioral Skills Model in people with Nursing Caries, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Information-Motivation-Behavioral Skills Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Communication disability (visual, hearing, mental retardation)
- No another chronic disease other than epilepsy
- Illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nursing Caries
- Being tested
- Information-Motivation-Behavioral Skills Model
- Keywords
- adolescent, epilepsy, education training, pediatric nursing, Information-Motivation-Behavioral Skills Model
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information-Motivation-Behavioral Skills ModelBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| IBM Educational Training | Experimental | Intervention group participants will receive IBM skills model on educational training intervention for 8 weeks. Receives: Behavioral: Information-Motivation-Behavioral Skills Model |
| Control Group | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean score of adolescents in the epilepsy disease knowledge test
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.
Measured: an average of 3 month
Change in the mean score of adolescents in the Seizure Self-Efficacy Scale in Children with Epilepsy
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
Measured: an average of 3 month
Change in the mean score of adolescents in the Multidimensional Perceived Social Support Scale
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
Measured: an average of 3 month
Change in the mean score of adolescents in theChild's Attitude Towards His Own Illness Scale
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.
Measured: an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Nov 2023
- Primary completion8 Jun 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Guzel Polat, Mersin University
- Investigators
- Ayda Çelebioğlu, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045520
- Sponsor's protocol ID
- MersinU-HB-OGP-02
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tutar Guven S, Isler Dalgic A, Duman O. Evaluation of the efficiency of the web-based epilepsy education program (WEEP) for youth with epilepsy and parents: A randomized controlled trial. Epilepsy Behav. 2020 Oct;111:107142. doi: 10.1016/j.yebeh.2020.107142. Epub 2020 Jul 21.
PubMed 32702651Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
PubMed 18838059Fisher JD, Fisher WA, Williams SS, Malloy TE. Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psychol. 1994 May;13(3):238-50. doi: 10.1037//0278-6133.13.3.238.
PubMed 8055859Lerch MF, Thrane SE. Adolescents with chronic illness and the transition to self-management: A systematic review. J Adolesc. 2019 Apr;72:152-161. doi: 10.1016/j.adolescence.2019.02.010. Epub 2019 Mar 21.
PubMed 30903932Braga P, Mifsud J, D'Souza C, Clarke M, Honein A, Tovuudorj A, Pfafflin M. Education and epilepsy: Examples of good practice and cooperation. Report of the IBE Commission on Education. Epilepsy Behav. 2020 Feb;103(Pt A):106653. doi: 10.1016/j.yebeh.2019.106653. Epub 2019 Nov 21.
PubMed 31761687
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Information-Motivation-Behavioral Skills Model on Disease Management of Adolescents With Epilepsy: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06045520
- Acronym / sponsor ID
- MersinU-HB-OGP-02
- Conditions
- Nursing Caries
- Keywords
- adolescent, epilepsy, education training, pediatric nursing, Information-Motivation-Behavioral Skills Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IBM Educational Training | Experimental | Behavioral: Information-Motivation-Behavioral Skills ModelIntervention group participants will receive IBM skills model on educational training intervention for 8 weeks. |
| Control Group | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information-Motivation-Behavioral Skills Model1.-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 | Behavioural | IBM Educational Training |
Primary outcome
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 32702651Tutar Guven S, Isler Dalgic A, Duman O. Evaluation of the efficiency of the web-based epilepsy education program (WEEP) for youth with epilepsy and parents: A randomized controlled trial. Epilepsy Behav. 2020 Oct;111:107142. doi: 10.1016/j.yebeh.2020.107142. Epub 2020 Jul 21.
- Background: PubMed 18838059Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
- Background: PubMed 8055859Fisher JD, Fisher WA, Williams SS, Malloy TE. Empirical tests of an information-motivation-behavioral skills model of AIDS-preventive behavior with gay men and heterosexual university students. Health Psychol. 1994 May;13(3):238-50. doi: 10.1037//0278-6133.13.3.238.
- Background: PubMed 30903932Lerch MF, Thrane SE. Adolescents with chronic illness and the transition to self-management: A systematic review. J Adolesc. 2019 Apr;72:152-161. doi: 10.1016/j.adolescence.2019.02.010. Epub 2019 Mar 21.
- Background: PubMed 31761687Braga P, Mifsud J, D'Souza C, Clarke M, Honein A, Tovuudorj A, Pfafflin M. Education and epilepsy: Examples of good practice and cooperation. Report of the IBE Commission on Education. Epilepsy Behav. 2020 Feb;103(Pt A):106653. doi: 10.1016/j.yebeh.2019.106653. Epub 2019 Nov 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayda Çelebioğlu study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information-Motivation-Behavioral Skills Model in people with Nursing Caries, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean score of adolescents in the epilepsy disease knowledge test (time frame: an average of 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045520, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.