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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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