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

October 8, 2024 updated by: Büşra Kütük, Istanbul Medeniyet University

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Kadıköy
      • İstanbul, Kadıköy, Turkey, 34744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
At the beginning of the study (pre-test), 6 months after the pre-test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
At the beginning of the study (pre-test), 6 months after the pre-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Study Chair: Büşra Kütük, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26.03.2024/03-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

July through December of 2026

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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