Online Diabetes Clinic Support Program

NCT06767865 | Completed

• 1 other identifier: DokuzEU-IHH-DBB-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study highlights the potential of online diabetes clinic support programs in improving treatment adherence, reducing treatment-related anxiety, and enhancing self-management skills in insulin therapy. Telehealth interventions play a crucial role in optimizing diabetes care and supporting patients in managing their insulin treatment effectively.

Conditions

Endocrine System Diseases; Education; Nursing Education

Keywords

Insulin therapy; online clinic; continuous support and follow-up; type 2 diabetes

Outcome Measures

Primary Outcomes (5)

• Hypoglycemic Confidence Scale

  The Hypoglycemic Confidence Scale is a nine-item self-report scale developed by William Polonsky and colleagues in 2017 that examines the degree to which diabetic patients feel confident and comfortable about their ability to avoid hypoglycemia-related problems. It was developed for use in adults with diabetes (Type 1 and Type 2 who use insulin). The Hypoglycemic Confidence Scale focuses on three areas: 1. Self-confidence (e.g., confidence in recognizing and managing hypoglycemia before blood sugar drops too low) 2. Confidence in avoiding hypoglycemia at critical times (e.g., while driving, exercising, and sleeping) 3. Estimation of spouse/partner's confidence. The Hypoglycemic Confidence Scale items are scored between 1-4 (1; Not at all confident 2; Somewhat confident 3; Moderately confident 4; Very confident). The ninth scale item for diabetic individuals with a spouse is interpreted as: 1; Not at all confident 2; Somewhat confident 3; Moderately confident 4; Very confident.

  1 month

• Hypoglycemia Fear Survey (HFS):

  The Hypoglycemia Fear Survey- HFS, was used to determine the fear of hypoglycemia in diabetic individuals. This scale consists of two subgroups, behavior and anxiety, and a total of 33 items. The behavior subgroup of this scale consists of 15 items. In the behavior subgroup; diabetic individuals are asked about what they have done in their daily lives to prevent their blood glucose levels from falling in the last 6 months. The anxiety subgroup consists of 18 items, and individuals are asked how often they have worried about the items given due to the decrease in their blood glucose levels in the last 6 months. The answers range from; "0 points: never; 1 point: rarely; 2 points: sometimes; 3 points often; 4 points: always". The high score obtained indicates that the fear of hypoglycemia is high. The Turkish validity and reliability were made by Özgül Erol.

  1 month

• Diabetes Empowerment Scale (DES-Short Form):

  The validity and reliability of the scale were made in 2020. DES-SF was designed to assess the empowerment levels of individuals regarding their health status. The scale is a five-point Likert type and has eight items (scored between "Strongly disagree" = 1 and "Strongly agree = 5"). The scale does not have a cut-off score. The scale is calculated based on the average score. An increase in the average score indicates an increase in the empowerment level.

  1 month

• Psychological Insulin Resistance Scale (PIRS)

  The scale was developed by Song and colleagues in 2016. The scale, which is a 5-point Likert type (1: strongly agree, 2: agree, 3: undecided, 4: disagree, 5: strongly disagree), consists of 18 items and 2 sub-dimensions (Supportive factor and Psycho-cognitive/physical factor). The total score of the scale varies between 18-90. A high score obtained from the scale indicates that the patient's psychological resistance to insulin use is high. The scale was developed by Işık and Colleagues in 2021. As a result of the Turkish validity and reliability analysis, the scale consists of 12 items and 3 sub-dimensions (supportive, psycho-cognitive, physical factors). Cronbach's alpha coefficient was determined as 0.82.

  1 month

• Insulin Therapy Assessment Scale (ITAS)

  The scale was developed by Sürücü et al. in 2017. Number of sub-dimensions and items: It consists of two sub-dimensions and a total of 20 items. Positive attitude (4 items): Items 3, 8, 17 and 19; Negative attitude (16 items): Items 1, 2, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 18 and 20. Scale items are rated on a Likert type scale between "strongly disagree" and "strongly agree" and 5 points. The sum of four positively worded items (4-20) gives the positive evaluation sub-dimension, and the sum of 16 negatively worded items (16-80) gives the negative evaluation sub-dimension. The sum of the items (20 items) gives the total score (20-100). The scale total score is found by reversing the four positively worded items and summing them with the other 16 negatively worded items.

  1 month

Study Arms (2)

Experimental Group

EXPERIMENTAL

intervention+ Follow-up at 0-3-6 months

Other: online support programe

Control Group

NO INTERVENTION

Follow-up at 0-3-6 months

Interventions

online support programe OTHER

Individuals in the experimental group received online training and were subsequently provided with continuous follow-up, counseling, motivation and informative message support for three months. In addition, patients were given a target board containing a daily diabetes management program and were asked to use it for three months.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 and over,
• able to communicate in Turkish,
• diagnosed with type 2 diabetes,
• newly started insulin treatment,
• having and using information technology products (telephone, computer)
• willing to participate in the study voluntarily were included in the study.

You may not qualify if:

• Individuals with visual,
• auditory or cognitive impairments,
• a condition that prevents communication,
• cannot use information technology products,
• those who do not agree to participate in the study were not included.

Sponsors & Collaborators

• Dilek Büyükkaya Besen: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylül University

Izmir, Alsancak, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endocrine System Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dilek D Büyükkaya Besen, PhD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Individuals in the experimental group received online training and were subsequently provided with continuous follow-up, counseling, motivation and informative message support for three months. In addition, patients were given a target board containing a daily diabetes management program and were asked to use it for three months.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 10, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)