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

NCT06635460 | Not Yet Recruiting

• 1 other identifier: 26.03.2024/03-27
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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\' 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?

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

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

• Child Attitude Toward Illness Scale (CATIS)

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

Study Arms (2)

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.

Other: Motivational interviewing; Other: Social media-based patient monitoring

Interventions

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.

Intervention Group

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.

Intervention Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old,
• Diagnosed with type 1 DM at least 6 months ago,
• HbA1C level \>7.0,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34744, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 25142716 BACKGROUND

• 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.

  PMID: 31441523 BACKGROUND

• 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.

  PMID: 33298424 BACKGROUND

• 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.

  PMID: 35568602 BACKGROUND

• 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.

  PMID: 33371976 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Büşra Kütük

  İstanbul Medeniyet University

  STUDY CHAIR

Central Study Contacts

Büşra Kütük

CONTACT

+902162804104; busra.kutuk@medeniyet.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Researcher

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 15, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July through December of 2026
• 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.

Locations

TU (1)