Information Motivation Behavioral Skills Model's Effects on Adolescents With Type 1 Diabetes

NCT04486547 | Completed DMC

• 1 other identifier: 2018-059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To evaluate the effects of information-motivation-behavioral skills model interventions given by nurses during home visits on the knowledge levels, personal and social motivation levels, behavioral skills, and HbA1C levels of adolescents with poor glycemic control. Design: Randomized controlled study. Methods: 50 adolescents with type 1 diabetes were equally divided into study and control groups. Socio-Demographic Form, Diabetes Information Evaluation Form, The Child Attitude Toward Illness Scale, The Multidimensional Scale of Perceived Social Support, and Diabetes Management Self-Efficacy Scale were utilized in data collection. The scales were administered at the beginning of the study and six months later. HbA1c levels of adolescents were evaluated in the third and sixth months. Multiple home visits and phone calls were made to each participant in the intervention group. Interventions to improve the information-motivation-behavioral skills model-based knowledge, personal and social motivation, and behavioral skills were applied during the home visits.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; adolescent; information motivation behavioral skills model,; nurse

Outcome Measures

Primary Outcomes (5)

• Change from baseline knowledge level of adolescents at 6 months

  Information evaluated by Diabetes Information Evaluation Form.The total information score was calculated over 20 points, with 1 point given for correct answers and 0 points to missing or wrong answers.

  immediately before intervention and immediately after intervention

• Change from baseline personal motivation level of adolescents at 6 months

  Personal motivation evaluated by Child Attitude toward Illness Scale. The nine items of the Child Attitude toward Ilness Scale are rated on a 5-point Likert-type scale.

  immediately before intervention and immediately after intervention

• Change from baseline behavioral skills level of adolescents at 6 months

  Diabetes Management Self-Efficacy Scale were used to evaluate Behavioral Skills. The instrument includes 26 items rated from 1 (strongly agree) to 5 (strongly disagree). A higher score indicates a lower level of self-efficacy.

  immediately before intervention and immediately after intervention

• Change from baseline HbA1c levels of adolescents at 6 months

  Before intervention, at month 3 and after intervention HbA1c levels of adolescents were evaluated for glycemic control

  immediately before intervention, at month 3 and immediately after intervention

• Change from baseline social motivation level of adolescents at 6 months

  Social motivation evaluated by Multidimensional Scale of Perceived Social Support. The Multidimensional Scale of Perceived Social Support consists of 12 items and it is rated on a 7-point Likert-type scale.

  immediately before intervention and immediately after intervention

Study Arms (2)

Follow up Posttest and HbA1c

NO INTERVENTION

56.0% of the adolescents with type 1 diabetes were aged 12-14 years and 52.0% were male in the control group (n=25)

Information Motivation Behavioral Skills Based Intervention

EXPERIMENTAL

52.0% of the adolescents with type 1 diabetes were aged 15-18 years and 52.0% were female(n=25)

Behavioral: Information-Motivation-Behavioral Skills model-based intervention

Interventions

Information-Motivation-Behavioral Skills model-based intervention BEHAVIORAL

Home visits were made to the study group and nursing interventions were administered in accordance with the components of the Information-Motivation-Behavioral Skills model

Information Motivation Behavioral Skills Based Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age An HbA1c level of ≥7.5

You may not qualify if:

• Diagnosed within the last 6 months An HbA1c level of ˂7.5 Using insulin pumps Having chronic diseases other than diabetes Living in another city Declining to participate

Sponsors & Collaborators

• Elif Bakır: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• HİCRAN ÇAVUŞOĞLU

  HACETTEPE UNIVESİTY NURSING FACULTY

  STUDY CHAIR

• EDA MENGEN

  Ankara Pediatric Hematology Oncology Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR. Principal Investigator

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 24, 2020
• Study Start: October 15, 2018
• Primary Completion: August 15, 2019
• Study Completion: December 15, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)