<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486547</url>
  </required_header>
  <id_info>
    <org_study_id>2018-059</org_study_id>
    <nct_id>NCT04486547</nct_id>
  </id_info>
  <brief_title>Information Motivation Behavioral Skills Model's Effects on Adolescents With Type 1 Diabetes</brief_title>
  <official_title>Interviewing Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elif Bakır</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To evaluate the effects of information-motivation-behavioral skills model interventions&#xD;
      given by nurses during home visits on the knowledge levels, personal and social motivation&#xD;
      levels, behavioral skills, and HbA1C levels of adolescents with poor glycemic control.&#xD;
&#xD;
      Design: Randomized controlled study. Methods: 50 adolescents with type 1 diabetes were&#xD;
      equally divided into study and control groups. Socio-Demographic Form, Diabetes Information&#xD;
      Evaluation Form, The Child Attitude Toward Illness Scale, The Multidimensional Scale of&#xD;
      Perceived Social Support, and Diabetes Management Self-Efficacy Scale were utilized in data&#xD;
      collection. The scales were administered at the beginning of the study and six months later.&#xD;
      HbA1c levels of adolescents were evaluated in the third and sixth months. Multiple home&#xD;
      visits and phone calls were made to each participant in the intervention group. Interventions&#xD;
      to improve the information-motivation-behavioral skills model-based knowledge, personal and&#xD;
      social motivation, and behavioral skills were applied during the home visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims The aim of the study was to evaluate the effects of IMB model interventions conducted by&#xD;
      nurses during home visits on the knowledge levels, personal and social motivation levels,&#xD;
      behavioral skills, and HbA1c levels of adolescents with T1DM. The study also aimed to test&#xD;
      the following hypotheses: T1DM adolescents who experienced an IMB model-based intervention&#xD;
      during a home visit will have more knowledge (H1) and more positive attitudes (H2) about&#xD;
      their disease, higher levels of perceived social support (H3), higher levels of self-efficacy&#xD;
      (H4), and lower levels of HbA1c (H5) than the control group Design A randomized controlled&#xD;
      experimental study was conducted to test the hypotheses above and explore the aforementioned&#xD;
      aim.&#xD;
&#xD;
      Sample/Participants The study was conducted with patients (n=50) of the Pediatric Endocrine&#xD;
      Clinic of the Ankara Pediatric Hematology Oncology Training and Research Hospital between&#xD;
      October 2018 and August 2019. The researchers evaluated the results of T1DM adolescents with&#xD;
      HbA1c measurements at the clinic for 4 months and included those who met the inclusion&#xD;
      criteria. The inclusion criteria were: (1) a T1DM diagnosis established at least six months&#xD;
      ago, (2) an HbA1c level of &gt;7.5, (3) not using insulin pumps, (4) the absence of any chronic&#xD;
      disease other than diabetes, (5) attending follow-up visits at the clinic once every three&#xD;
      months, and (6) living in Ankara. Adolescents were included in the study after an assessment&#xD;
      of the HbA1c level. Adolescents who met the inclusion criteria were then grouped into study&#xD;
      (n=25) and control (n=25) groups in order of arrival at the clinic, using stratified&#xD;
      randomization by gender to ensure homogeneity.&#xD;
&#xD;
      The sample size was calculated based on the mean HbA1c level and standard deviations in the&#xD;
      two groups in the power analysis made at the end of the research. An independent sample&#xD;
      t-test was used to establish the 1.4-unit difference in mean HbA1c levels, and a power of&#xD;
      99.107% was achieved.&#xD;
&#xD;
      Data Collection The Sociodemographic Information Form prepared by the researcher consisted of&#xD;
      six items regarding sociodemographic data and information on the participants.&#xD;
&#xD;
      Diabetes Information Evaluation Form (DIEF), Child Attitude toward Illness Scale (CATIS),&#xD;
      Multidimensional Scale of Perceived Social Support (MSPSS), and Diabetes Management&#xD;
      Self-Efficacy Scale (DMSES) were used to evaluate the components of the IMB model, and on the&#xD;
      assessment of HbA1c.&#xD;
&#xD;
      The researcher attended a two-stage &quot;Motivational Interviewing Techniques&quot; course and&#xD;
      received a certificate recognizing their ability to apply motivational interviewing&#xD;
      techniques. The eligible participants and their parents were informed about the research, and&#xD;
      written consent from the parents and written approvals from the adolescents were obtained.&#xD;
&#xD;
      Afterwards, home visits were made to the study group and nursing interventions were&#xD;
      administered in accordance with the components of the IMB model. Information was provided in&#xD;
      accordance with the adolescent's requirements, established from a pretest using the Diabetes&#xD;
      Information Evaluation Form. For the personal motivation component, a list of obstacles and&#xD;
      risky behaviors perceived by the patient in managing diabetes was created collaboratively.&#xD;
      Patients were asked to think about the factors facilitating the emergence of such behaviors,&#xD;
      as well as obstacles and negative perceptions, and potential solutions. Thereby, it aimed to&#xD;
      raise the awareness of their risky behaviors. Furthermore, the patients were enabled to&#xD;
      create positive values about themselves through the discovery of their strengths and&#xD;
      weaknesses. As for social motivation, patients were supported in obtaining help from their&#xD;
      loved ones when they felt unhappy. Cooperation with the diabetes team (physician, nurse,&#xD;
      dietician) regarding appropriate topics was emphasized.&#xD;
&#xD;
      The skills of adolescents in activities such as blood glucose measurement, ketone&#xD;
      measurement, insulin injection, record-keeping, administering additional insulin doses when&#xD;
      required, creating a balanced food list, calculating the carbohydrate content of foods, and&#xD;
      adjusting pre- and post-exercise insulin doses and meals were then evaluated. Feedback was&#xD;
      provided enabling adolescents to correct their mistakes and improve self-efficacy.&#xD;
&#xD;
      During phone interviews, blood glucose results of the patient were determined first before&#xD;
      the reasons were discussed. Taking into account the patient requirements, information was&#xD;
      provided on insulin administration, nutrition, and exercise. The duration of the phone&#xD;
      interviews varied from 2 to 15 minutes.&#xD;
&#xD;
      The control group adolescents received no intervention by the researcher throughout the&#xD;
      study. For these participants, blood glucose measurement records were reviewed during their&#xD;
      routine follow-ups at the hospital, their insulin doses were changed when necessary, and the&#xD;
      daily intake of carbohydrates were adjusted after consultation with a dietician. The control&#xD;
      group was informed that the scales would be re-administered six months later, and that they&#xD;
      had to attend the hospital for HbA1c assessment at three and six months. After the posttest,&#xD;
      incorrect answers by the control group were identified and information related to the&#xD;
      question was provided.&#xD;
&#xD;
      Ethical Aspects of the Research Ethics committee approval was granted by the Health Sciences&#xD;
      University Ankara Pediatric Hematology Oncology HARC Clinical Researches Ethics Committee on&#xD;
      April 16, 2018 with case no: 2018-059.&#xD;
&#xD;
      Data Analysis Data were evaluated using IBM SPSS Statistics 23 software and a p value of&#xD;
      &lt;0.05 was considered statistically significant. The results of a Shapiro-Wilk test indicated&#xD;
      a normal distribution of data, and so parametric tests were preferred in the study.&#xD;
&#xD;
      A dependent samples t-test was used to analyze the time-base differences of numerical&#xD;
      variables at two different time points, while a repeated measures variance of analysis was&#xD;
      used to examine the time-base differences at more than two different time points. The&#xD;
      difference in the mean scale scores of the two groups were analyzed using an&#xD;
      independent-samples t-test, while a Pearson's correlation analysis was used to examine the&#xD;
      association between the scales. The power analysis of the research was carried out using NCSS&#xD;
      PASS (Power Analysis and Sample Size) 11 software.&#xD;
&#xD;
      Validity and Reliability A Cronbach's alpha reliability analysis was performed to test the&#xD;
      reliability of the scales&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">August 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline knowledge level of adolescents at 6 months</measure>
    <time_frame>immediately before intervention and immediately after intervention</time_frame>
    <description>Information evaluated by Diabetes Information Evaluation Form.The total information score was calculated over 20 points, with 1 point given for correct answers and 0 points to missing or wrong answers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline personal motivation level of adolescents at 6 months</measure>
    <time_frame>immediately before intervention and immediately after intervention</time_frame>
    <description>Personal motivation evaluated by Child Attitude toward Illness Scale. The nine items of the Child Attitude toward Ilness Scale are rated on a 5-point Likert-type scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline behavioral skills level of adolescents at 6 months</measure>
    <time_frame>immediately before intervention and immediately after intervention</time_frame>
    <description>Diabetes Management Self-Efficacy Scale were used to evaluate Behavioral Skills. The instrument includes 26 items rated from 1 (strongly agree) to 5 (strongly disagree). A higher score indicates a lower level of self-efficacy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline HbA1c levels of adolescents at 6 months</measure>
    <time_frame>immediately before intervention, at month 3 and immediately after intervention</time_frame>
    <description>Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline social motivation level of adolescents at 6 months</measure>
    <time_frame>immediately before intervention and immediately after intervention</time_frame>
    <description>Social motivation evaluated by Multidimensional Scale of Perceived Social Support. The Multidimensional Scale of Perceived Social Support consists of 12 items and it is rated on a 7-point Likert-type scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Follow up Posttest and HbA1c</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>56.0% of the adolescents with type 1 diabetes were aged 12-14 years and 52.0% were male in the control group (n=25)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information Motivation Behavioral Skills Based Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>52.0% of the adolescents with type 1 diabetes were aged 15-18 years and 52.0% were female(n=25)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information-Motivation-Behavioral Skills model-based intervention</intervention_name>
    <description>Home visits were made to the study group and nursing interventions were administered in accordance with the components of the Information-Motivation-Behavioral Skills model</description>
    <arm_group_label>Information Motivation Behavioral Skills Based Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12-18 age An HbA1c level of ≥7.5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed within the last 6 months An HbA1c level of ˂7.5 Using insulin pumps Having&#xD;
             chronic diseases other than diabetes Living in another city Declining to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HİCRAN ÇAVUŞOĞLU</last_name>
    <role>Study Chair</role>
    <affiliation>HACETTEPE UNIVESİTY NURSING FACULTY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>EDA MENGEN</last_name>
    <role>Study Chair</role>
    <affiliation>Ankara Pediatric Hematology Oncology Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <state>Altındağ</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Elif Bakır</investigator_full_name>
    <investigator_title>DR. Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>adolescent</keyword>
  <keyword>information motivation behavioral skills model,</keyword>
  <keyword>nurse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The results of the research will be published in the scientific journal and shared with other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486547
org study id: 2018-059
nct id: NCT04486547
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim: To evaluate the effects of information-motivation-behavioral skills model interventions
      given by nurses during home visits on the knowledge levels, personal and social motivation
      levels, behavioral skills, and HbA1C levels of adolescents with poor glycemic control.

      Design: Randomized controlled study. Methods: 50 adolescents with type 1 diabetes were
      equally divided into study and control groups. Socio-Demographic Form, Diabetes Information
      Evaluation Form, The Child Attitude Toward Illness Scale, The Multidimensional Scale of
      Perceived Social Support, and Diabetes Management Self-Efficacy Scale were utilized in data
      collection. The scales were administered at the beginning of the study and six months later.
      HbA1c levels of adolescents were evaluated in the third and sixth months. Multiple home
      visits and phone calls were made to each participant in the intervention group. Interventions
      to improve the information-motivation-behavioral skills model-based knowledge, personal and
      social motivation, and behavioral skills were applied during the home visits.
Aims The aim of the study was to evaluate the effects of IMB model interventions conducted by
      nurses during home visits on the knowledge levels, personal and social motivation levels,
      behavioral skills, and HbA1c levels of adolescents with T1DM. The study also aimed to test
      the following hypotheses: T1DM adolescents who experienced an IMB model-based intervention
      during a home visit will have more knowledge (H1) and more positive attitudes (H2) about
      their disease, higher levels of perceived social support (H3), higher levels of self-efficacy
      (H4), and lower levels of HbA1c (H5) than the control group Design A randomized controlled
      experimental study was conducted to test the hypotheses above and explore the aforementioned
      aim.

      Sample/Participants The study was conducted with patients (n=50) of the Pediatric Endocrine
      Clinic of the Ankara Pediatric Hematology Oncology Training and Research Hospital between
      October 2018 and August 2019. The researchers evaluated the results of T1DM adolescents with
      HbA1c measurements at the clinic for 4 months and included those who met the inclusion
      criteria. The inclusion criteria were: (1) a T1DM diagnosis established at least six months
      ago, (2) an HbA1c level of >7.5, (3) not using insulin pumps, (4) the absence of any chronic
      disease other than diabetes, (5) attending follow-up visits at the clinic once every three
      months, and (6) living in Ankara. Adolescents were included in the study after an assessment
      of the HbA1c level. Adolescents who met the inclusion criteria were then grouped into study
      (n=25) and control (n=25) groups in order of arrival at the clinic, using stratified
      randomization by gender to ensure homogeneity.

      The sample size was calculated based on the mean HbA1c level and standard deviations in the
      two groups in the power analysis made at the end of the research. An independent sample
      t-test was used to establish the 1.4-unit difference in mean HbA1c levels, and a power of
      99.107% was achieved.

      Data Collection The Sociodemographic Information Form prepared by the researcher consisted of
      six items regarding sociodemographic data and information on the participants.

      Diabetes Information Evaluation Form (DIEF), Child Attitude toward Illness Scale (CATIS),
      Multidimensional Scale of Perceived Social Support (MSPSS), and Diabetes Management
      Self-Efficacy Scale (DMSES) were used to evaluate the components of the IMB model, and on the
      assessment of HbA1c.

      The researcher attended a two-stage "Motivational Interviewing Techniques" course and
      received a certificate recognizing their ability to apply motivational interviewing
      techniques. The eligible participants and their parents were informed about the research, and
      written consent from the parents and written approvals from the adolescents were obtained.

      Afterwards, home visits were made to the study group and nursing interventions were
      administered in accordance with the components of the IMB model. Information was provided in
      accordance with the adolescent's requirements, established from a pretest using the Diabetes
      Information Evaluation Form. For the personal motivation component, a list of obstacles and
      risky behaviors perceived by the patient in managing diabetes was created collaboratively.
      Patients were asked to think about the factors facilitating the emergence of such behaviors,
      as well as obstacles and negative perceptions, and potential solutions. Thereby, it aimed to
      raise the awareness of their risky behaviors. Furthermore, the patients were enabled to
      create positive values about themselves through the discovery of their strengths and
      weaknesses. As for social motivation, patients were supported in obtaining help from their
      loved ones when they felt unhappy. Cooperation with the diabetes team (physician, nurse,
      dietician) regarding appropriate topics was emphasized.

      The skills of adolescents in activities such as blood glucose measurement, ketone
      measurement, insulin injection, record-keeping, administering additional insulin doses when
      required, creating a balanced food list, calculating the carbohydrate content of foods, and
      adjusting pre- and post-exercise insulin doses and meals were then evaluated. Feedback was
      provided enabling adolescents to correct their mistakes and improve self-efficacy.

      During phone interviews, blood glucose results of the patient were determined first before
      the reasons were discussed. Taking into account the patient requirements, information was
      provided on insulin administration, nutrition, and exercise. The duration of the phone
      interviews varied from 2 to 15 minutes.

      The control group adolescents received no intervention by the researcher throughout the
      study. For these participants, blood glucose measurement records were reviewed during their
      routine follow-ups at the hospital, their insulin doses were changed when necessary, and the
      daily intake of carbohydrates were adjusted after consultation with a dietician. The control
      group was informed that the scales would be re-administered six months later, and that they
      had to attend the hospital for HbA1c assessment at three and six months. After the posttest,
      incorrect answers by the control group were identified and information related to the
      question was provided.

      Ethical Aspects of the Research Ethics committee approval was granted by the Health Sciences
      University Ankara Pediatric Hematology Oncology HARC Clinical Researches Ethics Committee on
      April 16, 2018 with case no: 2018-059.

      Data Analysis Data were evaluated using IBM SPSS Statistics 23 software and a p value of
      <0.05 was considered statistically significant. The results of a Shapiro-Wilk test indicated
      a normal distribution of data, and so parametric tests were preferred in the study.

      A dependent samples t-test was used to analyze the time-base differences of numerical
      variables at two different time points, while a repeated measures variance of analysis was
      used to examine the time-base differences at more than two different time points. The
      difference in the mean scale scores of the two groups were analyzed using an
      independent-samples t-test, while a Pearson's correlation analysis was used to examine the
      association between the scales. The power analysis of the research was carried out using NCSS
      PASS (Power Analysis and Sample Size) 11 software.

      Validity and Reliability A Cronbach's alpha reliability analysis was performed to test the
      reliability of the scales
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline knowledge level of adolescents at 6 months
time frame: immediately before intervention and immediately after intervention
description: Information evaluated by Diabetes Information Evaluation Form.The total information score was calculated over 20 points, with 1 point given for correct answers and 0 points to missing or wrong answers.
measure: Change from baseline personal motivation level of adolescents at 6 months
time frame: immediately before intervention and immediately after intervention
description: Personal motivation evaluated by Child Attitude toward Illness Scale. The nine items of the Child Attitude toward Ilness Scale are rated on a 5-point Likert-type scale.
measure: Change from baseline behavioral skills level of adolescents at 6 months
time frame: immediately before intervention and immediately after intervention
description: Diabetes Management Self-Efficacy Scale were used to evaluate Behavioral Skills. The instrument includes 26 items rated from 1 (strongly agree) to 5 (strongly disagree). A higher score indicates a lower level of self-efficacy.
measure: Change from baseline HbA1c levels of adolescents at 6 months
time frame: immediately before intervention, at month 3 and immediately after intervention
description: Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control
measure: Change from baseline social motivation level of adolescents at 6 months
time frame: immediately before intervention and immediately after intervention
description: Social motivation evaluated by Multidimensional Scale of Perceived Social Support. The Multidimensional Scale of Perceived Social Support consists of 12 items and it is rated on a 7-point Likert-type scale.
arm group label: Follow up Posttest and HbA1c
arm group type: No Intervention
description: 56.0% of the adolescents with type 1 diabetes were aged 12-14 years and 52.0% were male in the control group (n=25)
arm group label: Information Motivation Behavioral Skills Based Intervention
arm group type: Experimental
description: 52.0% of the adolescents with type 1 diabetes were aged 15-18 years and 52.0% were female(n=25)
intervention type: Behavioral
intervention name: Information-Motivation-Behavioral Skills model-based intervention
description: Home visits were made to the study group and nursing interventions were administered in accordance with the components of the Information-Motivation-Behavioral Skills model
arm group label: Information Motivation Behavioral Skills Based Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: HİCRAN ÇAVUŞOĞLU
role: Study Chair
affiliation: HACETTEPE UNIVESİTY NURSING FACULTY
last name: EDA MENGEN
role: Study Chair
affiliation: Ankara Pediatric Hematology Oncology Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Hacettepe University
investigator full name: Elif Bakır
investigator title: DR. Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
ipd description: The results of the research will be published in the scientific journal and shared with other researchers