The Effect of Telephone Consulting on HbA1 and Self-Management

Type 2 Diabetes Clinical Trial

Official title:

The Effect of Telephone Consultancy Based on the Information, Motivation and Behavioral Skills Model on HbA1c and Self-Management for Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723628
• Other study ID #: AksarayU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2021
• Source: Aksaray University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c.

Description:

The aim of this study was to investigate the effect of telephone counseling based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c. This study was conducted with a randomized controlled trial. This study, between January 2019 and September 2019 were conducted in endocrine clinic. A total of 63 patients (31 interventions, 32 controls) diagnosed with T2DM were included. The intervention group received 45-60 minutes of patient training based on the Information, Motivation and Behavioral Skill Model (IMB). A weekly short reminder message and a two-weekly phone call were made and a total of 12 weeks of follow-up was conducted. As a result, there was a statistically significant difference between pre-test HbA1c, weight and systolic blood pressure (p<0.05). Also, after three months of follow-up, self-efficacy, self-management and self-management perceptions were significantly higher in the intervention group (p<0.05).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis with type 2 DM at least six months previously

• Using a mobile phone

• HbA1c greater than 7%

• Living in the city

• Physical and mental health levels adequate for participation in the research

Exclusion Criteria:

• Having severe hearing or perceptual deficits that impaired communication

• Patients who did not agree to participate in the study

• Receiving inpatient treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Self-management
• Type 2 Diabetes

Intervention

Behavioral:
• Intervention group (telephone counseling)
Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.

Locations

Country	Name	City	State
Turkey	Kadriye Sayin Kasar	Aksaray	Ilçe Seçiniz

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.	3 months
Secondary	Type 2 Diabetes Self-Efficacy Scale	The lowest score obtainable from the scale is 20, and the highest is 100. In the general evaluation of the scale according to the total mean score obtained based on the mean scores of all the subscales, those below the mean score are accepted as low self-efficacy and those above the mean score are accepted as high self-efficacy.	3 months
Secondary	Diabetes Self-Management Questionnaire (DSMQ)	This scale is an individual assessment scale consisting of 16 items to investigate the relationship between diabetes self-management and diabetes control in glycemic control.	3 months
Secondary	Perceived Diabetes Self-Management Scale (PDSMS)	The minimum score which can be obtained from the scale is 8 and the maximum score is 40. A higher total score obtained indicates a better awareness by the person of diabetes management.	3 months