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The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM

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ClinicalTrials.gov Identifier: NCT05030844
Recruitment Status : Recruiting
First Posted : September 1, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
EDA KILINÇ, Pamukkale University

Tracking Information
First Submitted Date  ICMJE August 30, 2021
First Posted Date  ICMJE September 1, 2021
Last Update Posted Date October 26, 2021
Actual Study Start Date  ICMJE July 14, 2021
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
  • The change in diabetes knowledge level of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Knowledge Scale. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes health belief of individuals with Type 2 diabetes at 12 and 24 weeks with the Health Belief Model Scale in Diabetes Patients. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes self efficacy of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Self-Efficacy Scale. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes self managament of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Self-Management Scale [ Time Frame: baseline, 12 week and 24 week ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • HbA1c [ Time Frame: baseline, 12 week and 24 week ]
    Measurement of changes in HbA1c levels of individuals with Type 2 diabetes at 12 and 24 weeks.
  • Body Mass Index [ Time Frame: baseline, 12 week and 24 week ]
    Measurement of changes in BMI levels of individuals with Type 2 diabetes at 12 and 24 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2021)
Metabolic control variables [ Time Frame: baseline, 12 week and 24 week ]
Measurement of changes in HbA1c and Body Mass Index levels of individuals with Type 2 diabetes at 12 and 24 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • The change in diabetes knowledge level of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Knowledge Scale. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes health belief of individuals with Type 2 diabetes at 12 and 24 weeks with the Health Belief Model Scale in Diabetes Patients. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes self efficacy of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Self-Efficacy Scale. [ Time Frame: baseline, 12 week and 24 week ]
    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.
  • The change in diabetes self managament of individuals with Type 2 diabetes at 12 and 24 weeks with the Diabetes Self-Management Scale [ Time Frame: baseline, 12 week and 24 week ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With T2DM
Official Title  ICMJE The Effect of IMB Model-Based Diabetes Education and Motivational Interviewing on Care Outcomes in Adults With Type 2 Diabetes-A Randomized Controlled Study
Brief Summary This study was conducted to examine the effects of IMB model-based education and telephone-based Motivational Interviewing for adults with Type 2 diabetes on care outcomes This study was conducted to examine the effects of IMB model-based education and telephone-based Motivational Interviewing interventions on care outcomes for adults with Type 2 diabetes (HbA1c, BKİ, diabetes knowledge, health belief, self-efficacy, self-management).
Detailed Description IMB model-based interventions were applied to the intervention group for 12 weeks. 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, a 30-minute motivational interview was made with individual video calls once every two weeks starting from the third week. The control group received usual care. HbA1c, BMI, diabetes knowledge, health belief, diabetes self-efficacy, and diabetes self-management were measured at baseline, at 12 weeks, and at 24 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study is a parallel group randomized controlled study
Masking: Single (Participant)
Masking Description:
Single blinding was provided that included inclusion criteria and agreement to participate in the study.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Type2 Diabetes
  • HbA1c
  • BMI
  • Self Efficacy
  • Self Management
Intervention  ICMJE Behavioral: Diabetes Education and Video Call-based Motivational Interviewing
IMB model-based interventions were applied to the intervention group for 12 weeks. 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, a 30-minute motivational interview was made with individual video calls once every two weeks starting from the third week. The control group received usual care. HbA1c, BMI, diabetes knowledge, health belief, diabetes self-efficacy, and diabetes self-management were measured at baseline, at 12 weeks, and at 24 weeks.
Study Arms  ICMJE
  • Experimental: Intervention Group
    IMB model-based interventions were applied to the intervention group for 12 weeks. 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, a 30-minute motivational interview was made with individual video calls once every two weeks starting from the third week.
    Intervention: Behavioral: Diabetes Education and Video Call-based Motivational Interviewing
  • No Intervention: Control Group
    The control group received routine nursing care in the endocrine policlinic.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 20, 2022
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05030844
Other Study ID Numbers  ICMJE EKILINC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EDA KILINÇ, Pamukkale University
Study Sponsor  ICMJE Pamukkale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pamukkale University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP