NCT05030844

Brief Summary

This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based diabetes education and Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (diabetes knowledge, health belief, self-efficacy, self-management, HbA1c and BKİ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

August 30, 2021

Last Update Submit

October 1, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • The change in diabetes knowledge level of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Knowledge Scale.

    This scale was used to measure the knowledge component in the IMB model of individuals. The scale was developed by Erener Yavuz and Erol (2019) to measure the knowledge level of adults with diabetes. The scale consists of 5 sub-dimensions, including General Information on Diabetes (6 items), Blood Glucose Measurements and Values (5 items), Diabetes Risk Factors (4 items), Diabetes Symptoms (8 items), Diabetes Complications (5 items), and 28 consists of matter. Scale answers consist of two sets of items, true and false. Among the yes/no/don't know answer type questions, 1 point is given to those who give correct answers, 0 points are given to those who do not know and give wrong answers. The maximum score that can be obtained from the scale is 28, and the minimum score is 0.

    baseline, 3rd month and 6 rd month

  • The change in diabetes health belief of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Health Belief Model Scale in Diabetes Patients.

    This scale was used to measure the individual motivation component in the IMB model of individuals. The scale consists of 5 sub-dimensions and 33 items: perceived sensitivity (4 items), perceived seriousness (3 items), perceived benefits (7 items), perceived barriers (9 items), recommended health-related activities (10 items). The mean score of each sub-dimension is determined by dividing the total scores of all items in the sub-dimension by the total number of items. The total scale mean score is calculated by dividing the total scores of all scale items by the total number of items. The minimum score for each item is 1 and the maximum score is 5. Rating was made as strongly disagree (1), strongly agree (5). Low scores indicate negative and high scores indicate positive health beliefs. If the mean score for each item is 4 and above, it indicates high or positive health belief, and if the mean score is less than 4, it indicates low health belief.

    baseline, 3rd month and 6 rd month

  • The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.

    The "Self-Efficacy Scale" for diabetes management in type 2 diabetes patients was developed to determine the perception of diabetes patients' own power to carry out their own care activities. The items that make up the scale are based on the following activities. Activities to be done for diabetes treatment (drug use, diet, physical exercise), self-monitoring, self-control (knowing the value of blood sugar, body weight, foot control, general health), regulating their own activities (hypoglycemia, hyperglycemia correction, preparing for vacation) change in diet, overweight, self-control in case of illness and stress). The scale consists of 20 items. The lowest score to be taken from the scale is 20, and the highest score is 100.

    baseline, 3rd month and 6 rd month

  • The change in diabetes self managament of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Management Scale

    This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.

    baseline, 3rd month and 6 rd month

Secondary Outcomes (1)

  • Metabolic control variables

    baseline, 3rd month and 6 rd month

Study Arms (2)

Intervention Group

EXPERIMENTAL

IMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.

Behavioral: IMB model based Diabetes Education and Motivational Interviewing

Control Group

NO INTERVENTION

The control group received routine nursing care in the endocrine policlinic.

Interventions

IMB model-based interventions were applied to the intervention group for 3 month. For the information component of the IMB model, diabetes education consisting of four sessions was given in groups of five in the first two weeks. Each patient was given a "Diabetes Management Education Booklet" prepared by the researchers. For the motivation component of the IMB model, total 5 sessions 30-minute motivational interview was made with individual Whatsapp calls once every two weeks starting from the third week.

Intervention Group

Eligibility Criteria

Age30 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those between the ages of 30-64
  • Receiving insulin therapy
  • BMI value of 25 and above
  • HbA1c of 7 and above
  • At least primary school graduate and can speak Turkish
  • No communication barrier (speech, vision or hearing problem)
  • Having a smart phone and internet access
  • Individuals who agree to participate in the research.

You may not qualify if:

  • Those who have retinopathy at a level that may hinder the sense of sight.
  • Those with neuropathy at a level that prevents them from doing their daily physical activities
  • Diagnosed with kidney failure
  • Using an insulin pump
  • Pregnant
  • Those with a diagnosis of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilinc Isleyen E, Kartal A. The effect of information, motivation and behavioural skills model-based Diabetes Education and Motivational Interview Program on health outcomes in middle-aged adults with type 2 diabetes: a randomised controlled study. Psychogeriatrics. 2025 Jan;25(1):e13219. doi: 10.1111/psyg.13219. Epub 2024 Nov 19.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinding was provided that included inclusion criteria and agreement to participate in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a parallel group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 1, 2021

Study Start

July 14, 2021

Primary Completion

October 14, 2021

Study Completion

February 14, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations