Clinical trial NCT06635460: Motivational Interviewing and WhatsApp-Based Monitoring for Metabolic Control and Self-Efficacy in Adolescents With T1DM
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus (T1DM)
Motivational Interviewing
Metabolic Control
Keywords: Type 1 diabetes mellitus
adolescent
motivational interviewing
social media-based monitoring
metabolic control
Self efficacy
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 56
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. Additionally, the study will assess the adolescents\&amp;#39; 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.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* Using an insulin pump,
* Having a chronic disease other than diabetes,
* Cognitive, intellectual, hearing, vision, or speech disabilities

Primary outcomes:
measure: HbA1c test
timeFrame: At the beginning of the study (pre-test), 3 months after the pre-test, 6 months after the pre-test
measure: Diabetes Management Self-Efficacy Scale
timeFrame: At the beginning of the study (pre-test), 6 months after the pre-test
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module
timeFrame: At the beginning of the study (pre-test), 6 months after the pre-test
measure: Child Attitude Toward Illness Scale (CATIS)
timeFrame: At the beginning of the study (pre-test), 6 months after the pre-test
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: İstanbul Medeniyet University
name: Büşra Kütük
role: STUDY_CHAIR
References:
citation: 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.
citation: Guo 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.
citation: American 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.
citation: Al 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.
citation: Bakir 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.