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The Effect of Telephone Consulting on HbA1 and Self-Management

Primary Purpose

Type 2 Diabetes, Self-management

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intervention group (telephone counseling)
Sponsored by
Aksaray University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Telephone counseling, IMB, Self-management, HbA1c

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kadriye Sayin Kasar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

All data forms were then completed, and the HbA1c value was taken from the medical data. No additional procedure was performed to the control group. The research data were collected again at the end of 12 weeks.

Outcomes

Primary Outcome Measures

Glycemic Control
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 18, 2021
Last Updated
January 20, 2021
Sponsor
Aksaray University
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1. Study Identification

Unique Protocol Identification Number
NCT04723628
Brief Title
The Effect of Telephone Consulting on HbA1 and Self-Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Self-management
Keywords
Type 2 diabetes, Telephone counseling, IMB, Self-management, HbA1c

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
All data forms were then completed, and the HbA1c value was taken from the medical data. No additional procedure was performed to the control group. The research data were collected again at the end of 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group (telephone counseling)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycemic Control
Description
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Type 2 Diabetes Self-Efficacy Scale
Description
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.
Time Frame
3 months
Title
Diabetes Self-Management Questionnaire (DSMQ)
Description
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.
Time Frame
3 months
Title
Perceived Diabetes Self-Management Scale (PDSMS)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kadriye Sayin Kasar
City
Aksaray
State/Province
İlçe Seçiniz
ZIP/Postal Code
68100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34518109
Citation
Sayin Kasar K, Duru Asiret G, Kutmec Yilmaz C, Canlar S. The effect of model-based telephone counseling on HbA1c and self-management for individuals with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):41-48. doi: 10.1016/j.pcd.2021.09.005. Epub 2021 Sep 11.
Results Reference
derived

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The Effect of Telephone Consulting on HbA1 and Self-Management

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