Type 1 DiabetesNCT04486547
Information Motivation Behavioral Skills Model's Effects on Adolescents With Type 1 Diabetes
A study testing Information-Motivation-Behavioral Skills model-based intervention in people with Type 1 Diabetes, run by Elif Bakır at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Information-Motivation-Behavioral Skills model-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Dec 2019
- 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
- 12-18 age An HbA1c level of ≥7.5
Who cannot join
- Diagnosed within the last 6 months An HbA1c level of ˂7.5 Using insulin pumps Having chronic diseases other than diabetes Living in another city Declining to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interviewing Adolescents With Type 1 Diabetes
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.
Read the detailed description
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
- Conditions
- Type 1 Diabetes
- Being tested
- Information-Motivation-Behavioral Skills model-based intervention
- Keywords
- type 1 diabetes, adolescent, information motivation behavioral skills model,, nurse
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information-Motivation-Behavioral Skills model-based interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Follow up Posttest and HbA1c | No intervention | 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) |
| Information Motivation Behavioral Skills Based Intervention | Experimental | 52.0% of the adolescents with type 1 diabetes were aged 15-18 years and 52.0% were female(n=25) Receives: Behavioral: Information-Motivation-Behavioral Skills model-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline knowledge level of adolescents at 6 months
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.
Measured: immediately before intervention and immediately after intervention
Change from baseline personal motivation level of adolescents at 6 months
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.
Measured: immediately before intervention and immediately after intervention
Change from baseline behavioral skills level of adolescents at 6 months
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.
Measured: immediately before intervention and immediately after intervention
Change from baseline HbA1c levels of adolescents at 6 months
Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control
Measured: immediately before intervention, at month 3 and immediately after intervention
Change from baseline social motivation level of adolescents at 6 months
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.
Measured: immediately before intervention and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start15 Oct 2018
- Primary completion15 Aug 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Bakır
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elif Bakır, Hacettepe University
- Investigators
- HİCRAN ÇAVUŞOĞLU, Study chair, HACETTEPE UNIVESİTY NURSING FACULTYEDA MENGEN, Study chair, Ankara Pediatric Hematology Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486547
- Sponsor's protocol ID
- 2018-059
- Status last verified
- Jul 2020
- First submitted
- 8 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the research will be published in the scientific journal and shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interviewing Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04486547
- Acronym / sponsor ID
- 2018-059
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, adolescent, information motivation behavioral skills model,, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Elif BakırUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 24 Jul 2020 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up Posttest and HbA1c | No intervention | –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) |
| Information Motivation Behavioral Skills Based Intervention | Experimental | Behavioral: Information-Motivation-Behavioral Skills model-based intervention52.0% of the adolescents with type 1 diabetes were aged 15-18 years and 52.0% were female(n=25) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 12-18 age An HbA1c level of ≥7.5
Key exclusion criteria (1 listed)
- Diagnosed within the last 6 months An HbA1c level of ˂7.5 Using insulin pumps Having chronic diseases other than diabetes Living in another city Declining to participate
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 model-based interventionHome visits were made to the study group and nursing interventions were administered in accordance with the components of the Information-Motivation-Behavioral Skills model | Behavioural | Information Motivation Behavioral Skills Based Intervention |
Primary outcome
Change from baseline knowledge level of adolescents at 6 months
Time frame: immediately before intervention and immediately after intervention
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.
Change from baseline personal motivation level of adolescents at 6 months
Time frame: immediately before intervention and immediately after intervention
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.
Change from baseline behavioral skills level of adolescents at 6 months
Time frame: immediately before intervention and immediately after intervention
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.
Change from baseline HbA1c levels of adolescents at 6 months
Time frame: immediately before intervention, at month 3 and immediately after intervention
Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control
Change from baseline social motivation level of adolescents at 6 months
Time frame: immediately before intervention and immediately after intervention
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.
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 24 Jul 2020.
- Individual participant dataSharing planned: No. The results of the research will be published in the scientific journal and shared with other researchers
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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.
HİCRAN ÇAVUŞOĞLU study chair
HACETTEPE UNIVESİTY NURSING FACULTY
EDA MENGEN study chair
Ankara Pediatric Hematology Oncology Training and Research Hospital
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-based intervention in people with Type 1 Diabetes, run by Elif Bakır 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 1 inclusion and 1 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 24 Jul 2020. 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 from baseline knowledge level of adolescents at 6 months (time frame: immediately before intervention and immediately after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2020.