Type 1 Diabetes Mellitus (T1DM)NCT06635460
Motivational Interviewing and WhatsApp-Based Monitoring for Metabolic Control and Self-Efficacy in Adolescents With T1DM
A study testing Motivational interviewing and Social media-based patient monitoring in people with Type 1 Diabetes Mellitus (T1DM) and Motivational Interviewing, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aims to determine the effects of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), Motivational Interviewing, Metabolic Control
- What is being tested?
- Motivational interviewing and Social media-based patient monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Apr 2025
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-18 years old,
- Diagnosed with type 1 DM at least 6 months ago,
- HbA1C level >7.0,
- 3-monthly outpatient visits,
- Completed basic type 1 DM education and scored high (≥15 points) on the Type 1 Diabetes Knowledge Assessment Form,
- A WhatsApp user with a smart phone and internet access,
- Adolescents who can speak and understand Turkish.
Who cannot join
- Using an insulin pump,
- Having a chronic disease other than diabetes,
- Cognitive, intellectual, hearing, vision, or speech disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kadıköy, 34744
Aynur Aytekin Ozdemir, Professor, +902162804104, aynur.ozdemir@medeniyet.edu.tr
About this study
Official title: The Impact of Motivational Interviewing and Social Media-Based Patient Monitoring on Metabolic Control and Self-Efficacy in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
This clinical study aims to determine the effects of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with Type 1 diabetes. Additionally, the study will assess the adolescents\' attitudes toward their disease, quality of life, and perceived levels of social support. The primary research questions are as follows:
For adolescents with Type 1 diabetes who receive motivational interviewing and social media-based monitoring:
How do their attitudes toward their disease compare to those in the control group? How do their perceived levels of social support compare to those in the control group? How do their self-efficacy levels compare to those in the control group? How does their quality of life compare to that of the control group? How do their HbA1c levels compare to those in the control group?
Read the detailed description
One of the most common chronic diseases in adolescence is type 1 diabetes mellitus (T1DM). T1DM is one of the most common endocrine diseases of childhood and requires lifelong management. To minimize the impact of T1DM on adolescents, metabolic control should be ensured, self-efficacy should be gained, quality of life should be improved, and anxiety should be reduced.
Because the epidemiology, pathophysiology, developmental status, and response to diabetes treatment are different in adolescents than in adults with diabetes, the care of adolescents should be different from that of adults. This population should be managed by a multidisciplinary team trained in pediatric diabetes management and sensitive to the difficulties of adolescents with T1DM. The diabetes nurse in this team is responsible for providing diabetes self-management education and support, medical nutrition therapy, and psychosocial support during and regularly after diagnosis. Interventions should focus on empowering adolescents to better manage their disease. Educational programs should include approaches such as teaching specific diabetes management skills and developing independence in these tasks (e.g., carbohydrate counting, blood glucose monitoring) and promoting autonomy and motivation.
Motivational interviewing techniques can be used to elicit behavior change by helping patients identify and resolve ambivalent feelings. Motivational interviewing is defined as a collaborative approach that elicits intrinsic motivation and strengthens commitment to behavior change goals. Motivating patients makes them feel ready to change their behavior and ensures that interventions to improve diabetes management are effective. Recent studies have shown that motivational interviewing also has a positive impact on diabetes self-management.
Today, social media is a valuable tool for people with diabetes to improve their self-management skills. Lifestyle changes such as diet and exercise, blood glucose monitoring, online education, peer support, and real-time interaction between patients and healthcare professionals can all be facilitated through social media. Therefore, it is recommended that healthcare professionals use social media-based applications to improve diabetes self-management skills and thereby improve glycemic control. This study will determine the effect of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with type 1 diabetes. It will also determine the attitudes of adolescents with T1DM toward their own disease, quality of life, and perceived level of social support.
- Being tested
- Motivational interviewing, Social media-based patient monitoring
- Keywords
- Type 1 diabetes mellitus, adolescent, motivational interviewing, social media-based monitoring, metabolic control, Self efficacy
- 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.
Motivational interviewingOther
This programme has been developed from the literature and structured according to expert opinion. It will consist of a total of 8 online sessions. The duration of the motivational interviewing sessions will be limited to 30-45 minutes, in line with the literature.
Social media-based patient monitoringOther
Blood glucose results, lowest and highest values, and reasons will be included in the content of the patient follow-up, which will be conducted at intervals on the WhatsApp platform. There will be a total of 10 follow-ups. Although the duration of the written dialog will vary among adolescents, it will be limited to an average of 2-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Adolescents in this group will be followed up according to the routine follow-up program of pediatric endocrinology. Adolescents in the control group will not receive any intervention from the researcher during the study. |
| Intervention Group | Experimental | Adolescents in this group will receive motivational interviewing and WhatsApp-based follow-up. Adolescents will be followed for 6 months. Online motivational interviewing sessions will occur once during the first 4 weeks. Meetings will then continue at 15-day intervals in the form of online motivational interview meetings and WhatsApp chats, respectively. Follow-up WhatsApp meetings will be held every 15 days for the next 3 months. The meetings will be conducted according to the "Intervention Group Meeting Content" prepared in accordance with the literature and expert opinion. The duration of the motivational meetings will be limited to 30-45 minutes in accordance with the literature. Blood glucose results, the lowest and highest values, and the reasons will be included in the content of patient follow-up, which will be conducted at intervals on the WhatsApp platform. Although the duration of written dialogues will vary among adolescents, it will be limited to an average of 2-10 min. Receives: Other: Motivational interviewing; Other: Social media-based patient monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c test
Participants will undergo HbA1c testing every 3 months throughout the study. These tests will serve as a long-term indicator of blood sugar control and one of the primary outcome measures of the study.
Measured: At the beginning of the study (pre-test), 3 months after the pre-test, 6 months after the pre-test
Diabetes Management Self-Efficacy Scale
The scale is used to assess the educational needs of adolescents or to evaluate the effectiveness of diabetes education programmes. The scale has 26 items. It has a Likert-type rating from 1 (strongly agree) to 5 (strongly disagree). The scale score is calculated by dividing the total self-efficacy score by the number of items to show the strength of perceived self-efficacy for different levels of performance. The minimum total score is 26 and the maximum is 130. A higher score indicates lower self-efficacy.
Measured: At the beginning of the study (pre-test), 6 months after the pre-test
Secondary outcomes (2)
Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module
The 28-item multidimensional PedsQL 3.0 Diabetes Module included five subscales, which are diabetes symptoms (11 items), treatment barriers (4 items), treatment adherence (7 items), worry (3 items), and communication (3 items). The format, instructions, Likert type response scale, and the scoring method are identical to the PedsQL, with higher scores indicating fewer symptoms or problems.
Measured: At the beginning of the study (pre-test), 6 months after the pre-test
Child Attitude Toward Illness Scale (CATIS)
The scale was developed to measure the attitudes of children with chronic illnesses towards their illness. The thirteen-item scale is scored as follows: 9 items were scored as 'very often, often, sometimes, not often, never' and 4 items were scored as 'very good, somewhat good, not sure, somewhat bad, very bad'. The scores for the 13 items were summed and divided by 13. The average score is between 1 and 5. Scores of 1 and 2 indicate a negative attitude, 3 a neutral attitude and 4 and 5 a positive attitude.
Measured: At the beginning of the study (pre-test), 6 months after the pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
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 Type 1 Diabetes Mellitus (T1DM)Studies 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
- Model description
- In the randomization scheme of the study, stratified and blocked randomization methods will be utilized. Age and gender variables will be used for the stratification of adolescents. Blocks will be formed as follows: for the age variable, "12-14 years" and "15-18 years" will be the categories, while for the gender variable, the categories will be "female" and "male." An online tool for generating blocked randomization lists will be employed. To achieve the calculated sample size for the study, each stratum will be repeated 7 times (2X2X7), resulting in a total inclusion of 56 adolescents, with each group comprising 28 participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kütük, Istanbul Medeniyet University
- Investigators
- Büşra Kütük, Study chair, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635460
- Sponsor's protocol ID
- 26.03.2024/03-27
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
Publications
Powell PW, Hilliard ME, Anderson BJ. Motivational interviewing to promote adherence behaviors in pediatric type 1 diabetes. Curr Diab Rep. 2014 Oct;14(10):531. doi: 10.1007/s11892-014-0531-z.
PubMed 25142716Guo J, Yang J, Wiley J, Ou X, Zhou Z, Whittemore R. Perceived stress and self-efficacy are associated with diabetes self-management among adolescents with type 1 diabetes: A moderated mediation analysis. J Adv Nurs. 2019 Dec;75(12):3544-3553. doi: 10.1111/jan.14179. Epub 2019 Oct 6.
PubMed 31441523American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S180-S199. doi: 10.2337/dc21-S013.
PubMed 33298424Al Ksir K, Wood DL, Hasni Y, Sahli J, Quinn M, Ghardallou M. Motivational interviewing to improve self-management in youth with type 1 diabetes: A randomized clinical trial. J Pediatr Nurs. 2022 Sep-Oct;66:e116-e121. doi: 10.1016/j.pedn.2022.05.001. Epub 2022 May 12.
PubMed 35568602Bakir E, Cavusoglu H, Mengen E. Effects of the Information-Motivation-Behavioral Skills Model on Metabolic Control of Adolescents with Type 1 Diabetes in Turkey: Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e19-e27. doi: 10.1016/j.pedn.2020.11.019. Epub 2020 Dec 25.
PubMed 33371976
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Motivational Interviewing and Social Media-Based Patient Monitoring on Metabolic Control and Self-Efficacy in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06635460
- Acronym / sponsor ID
- 26.03.2024/03-27
- Keywords
- Type 1 diabetes mellitus, adolescent, motivational interviewing, social media-based monitoring, metabolic control, Self efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
This clinical study aims to determine the effects of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with Type 1 diabetes. Additionally, the study will assess the adolescents\' attitudes toward their disease, quality of life, and perceived levels of social support. The primary research questions are as follows:
For adolescents with Type 1 diabetes who receive motivational interviewing and social media-based monitoring:
How do their attitudes toward their disease compare to those in the control group? How do their perceived levels of social support compare to those in the control group? How do their self-efficacy levels compare to those in the control group? How does their quality of life compare to that of the control group? How do their HbA1c levels compare to those in the control group?
Detailed description
One of the most common chronic diseases in adolescence is type 1 diabetes mellitus (T1DM). T1DM is one of the most common endocrine diseases of childhood and requires lifelong management. To minimize the impact of T1DM on adolescents, metabolic control should be ensured, self-efficacy should be gained, quality of life should be improved, and anxiety should be reduced.
Because the epidemiology, pathophysiology, developmental status, and response to diabetes treatment are different in adolescents than in adults with diabetes, the care of adolescents should be different from that of adults. This population should be managed by a multidisciplinary team trained in pediatric diabetes management and sensitive to the difficulties of adolescents with T1DM. The diabetes nurse in this team is responsible for providing diabetes self-management education and support, medical nutrition therapy, and psychosocial support during and regularly after diagnosis. Interventions should focus on empowering adolescents to better manage their disease. Educational programs should include approaches such as teaching specific diabetes management skills and developing independence in these tasks (e.g., carbohydrate counting, blood glucose monitoring) and promoting autonomy and motivation.
Motivational interviewing techniques can be used to elicit behavior change by helping patients identify and resolve ambivalent feelings. Motivational interviewing is defined as a collaborative approach that elicits intrinsic motivation and strengthens commitment to behavior change goals. Motivating patients makes them feel ready to change their behavior and ensures that interventions to improve diabetes management are effective. Recent studies have shown that motivational interviewing also has a positive impact on diabetes self-management.
Today, social media is a valuable tool for people with diabetes to improve their self-management skills. Lifestyle changes such as diet and exercise, blood glucose monitoring, online education, peer support, and real-time interaction between patients and healthcare professionals can all be facilitated through social media. Therefore, it is recommended that healthcare professionals use social media-based applications to improve diabetes self-management skills and thereby improve glycemic control. This study will determine the effect of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with type 1 diabetes. It will also determine the attitudes of adolescents with T1DM toward their own disease, quality of life, and perceived level of social support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In the randomization scheme of the study, stratified and blocked randomization methods will be utilized. Age and gender variables will be used for the stratification of adolescents. Blocks will be formed as follows: for the age variable, "12-14 years" and "15-18 years" will be the categories, while for the gender variable, the categories will be "female" and "male." An online tool for generating blocked randomization lists will be employed. To achieve the calculated sample size for the study, each stratum will be repeated 7 times (2X2X7), resulting in a total inclusion of 56 adolescents, with each group comprising 28 participants.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Adolescents in this group will be followed up according to the routine follow-up program of pediatric endocrinology. Adolescents in the control group will not receive any intervention from the researcher during the study. |
| Intervention Group | Experimental | Other: Motivational interviewing, Other: Social media-based patient monitoringAdolescents in this group will receive motivational interviewing and WhatsApp-based follow-up. Adolescents will be followed for 6 months. Online motivational interviewing sessions will occur once during the first 4 weeks. Meetings will then continue at 15-day intervals in the form of online motivational interview meetings and WhatsApp chats, respectively. Follow-up WhatsApp meetings will be held every 15 days for the next 3 months. The meetings will be conducted according to the "Intervention Group Meeting Content" prepared in accordance with the literature and expert opinion. The duration of the motivational meetings will be limited to 30-45 minutes in accordance with the literature. Blood glucose results, the lowest and highest values, and the reasons will be included in the content of patient follow-up, which will be conducted at intervals on the WhatsApp platform. Although the duration of written dialogues will vary among adolescents, it will be limited to an average of 2-10 min. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 13-18 years old,
- Diagnosed with type 1 DM at least 6 months ago,
- HbA1C level >7.0,
- 3-monthly outpatient visits,
- Completed basic type 1 DM education and scored high (≥15 points) on the Type 1 Diabetes Knowledge Assessment Form,
Key exclusion criteria (3 listed)
- Using an insulin pump,
- Having a chronic disease other than diabetes,
- Cognitive, intellectual, hearing, vision, or speech disabilities
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 |
|---|---|---|
| Motivational interviewingThis programme has been developed from the literature and structured according to expert opinion. It will consist of a total of 8 online sessions. The duration of the motivational interviewing sessions will be limited to 30-45 minutes, in line with the literature. | Other | Intervention Group |
| Social media-based patient monitoringBlood glucose results, lowest and highest values, and reasons will be included in the content of the patient follow-up, which will be conducted at intervals on the WhatsApp platform. There will be a total of 10 follow-ups. Although the duration of the written dialog will vary among adolescents, it will be limited to an average of 2-10 minutes. | Other | Intervention Group |
Primary outcome
HbA1c test
Time frame: At the beginning of the study (pre-test), 3 months after the pre-test, 6 months after the pre-test
Participants will undergo HbA1c testing every 3 months throughout the study. These tests will serve as a long-term indicator of blood sugar control and one of the primary outcome measures of the study.
Diabetes Management Self-Efficacy Scale
Time frame: At the beginning of the study (pre-test), 6 months after the pre-test
The scale is used to assess the educational needs of adolescents or to evaluate the effectiveness of diabetes education programmes. The scale has 26 items. It has a Likert-type rating from 1 (strongly agree) to 5 (strongly disagree). The scale score is calculated by dividing the total self-efficacy score by the number of items to show the strength of perceived self-efficacy for different levels of performance. The minimum total score is 26 and the maximum is 130. A higher score indicates lower self-efficacy.
2 secondary outcomes
Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module
Time frame: At the beginning of the study (pre-test), 6 months after the pre-test
Child Attitude Toward Illness Scale (CATIS)
Time frame: At the beginning of the study (pre-test), 6 months after the pre-test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 25142716Powell PW, Hilliard ME, Anderson BJ. Motivational interviewing to promote adherence behaviors in pediatric type 1 diabetes. Curr Diab Rep. 2014 Oct;14(10):531. doi: 10.1007/s11892-014-0531-z.
- Background: PubMed 31441523Guo J, Yang J, Wiley J, Ou X, Zhou Z, Whittemore R. Perceived stress and self-efficacy are associated with diabetes self-management among adolescents with type 1 diabetes: A moderated mediation analysis. J Adv Nurs. 2019 Dec;75(12):3544-3553. doi: 10.1111/jan.14179. Epub 2019 Oct 6.
- Background: PubMed 33298424American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S180-S199. doi: 10.2337/dc21-S013.
- Background: PubMed 35568602Al Ksir K, Wood DL, Hasni Y, Sahli J, Quinn M, Ghardallou M. Motivational interviewing to improve self-management in youth with type 1 diabetes: A randomized clinical trial. J Pediatr Nurs. 2022 Sep-Oct;66:e116-e121. doi: 10.1016/j.pedn.2022.05.001. Epub 2022 May 12.
- Background: PubMed 33371976Bakir E, Cavusoglu H, Mengen E. Effects of the Information-Motivation-Behavioral Skills Model on Metabolic Control of Adolescents with Type 1 Diabetes in Turkey: Randomized Controlled Study. J Pediatr Nurs. 2021 May-Jun;58:e19-e27. doi: 10.1016/j.pedn.2020.11.019. Epub 2020 Dec 25.
- Individual participant dataSharing planned: Yes. Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
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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.
Büşra Kütük study chair
İstanbul Medeniyet 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 Motivational interviewing and Social media-based patient monitoring in people with Type 1 Diabetes Mellitus (T1DM) and Motivational Interviewing, run by Istanbul Medeniyet 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 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Büşra Kütük (+902162804104, busra.kutuk@medeniyet.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c test (time frame: At the beginning of the study (pre-test), 3 months after the pre-test, 6 months after the pre-test). The study lists 2 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 NCT06635460, 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 10 Oct 2024.