Motivational Interviewing and WhatsApp-Based Monitoring for Metabolic Control and Self-Efficacy in Adolescents With T1DM

NCT ID: NCT06635460

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus (T1DM) Motivational Interviewing Metabolic Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type EXPERIMENTAL

Motivational interviewing

Intervention Type OTHER

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 monitoring

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Motivational interviewing

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.

Intervention Type OTHER

Social media-based patient monitoring

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Büşra Kütük

Assistant Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Büşra Kütük

Role: STUDY_CHAIR

İstanbul Medeniyet University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medeniyet University

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Büşra Kütük

Role: CONTACT

+902162804104

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aynur Aytekin Ozdemir, Professor

Role: primary

+902162804104

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25142716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31441523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33298424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35568602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33371976 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

26.03.2024/03-27

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.