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NCT Number: NCT06635460

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

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?

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Kadıköy, 34744, Turkey (Türkiye)

Location contact

Aynur Aytekin Ozdemir, Professor

CONTACT

[email protected]

+902162804104

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

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

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. Child Attitude Toward Illness Scale (CATIS)

    Time frame: At the beginning of the study (pre-test), 6 months after the pre-test

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Kütük

CONTACT

[email protected]

+902162804104

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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