The Effect of Telephone Consulting on HbA1 and Self-Management

January 20, 2021 updated by: KADRİYE SAYIN KASAR, Aksaray University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İlçe Seçiniz
      • Aksaray, İlçe Seçiniz, Turkey, 68100
        • Kadriye Sayin Kasar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
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.
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.
NO_INTERVENTION: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Control
Time Frame: 3 months
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type 2 Diabetes Self-Efficacy Scale
Time Frame: 3 months
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
Diabetes Self-Management Questionnaire (DSMQ)
Time Frame: 3 months
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
Perceived Diabetes Self-Management Scale (PDSMS)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aksaray University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (ACTUAL)

January 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AksarayU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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