NCT04723628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 18, 2021

Last Update Submit

January 20, 2021

Conditions

Keywords

Type 2 diabetesTelephone counselingIMBSelf-managementHbA1c

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Type 2 Diabetes Self-Efficacy Scale

    3 months

  • Diabetes Self-Management Questionnaire (DSMQ)

    3 months

  • Perceived Diabetes Self-Management Scale (PDSMS)

    3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having severe hearing or perceptual deficits that impaired communication
  • Patients who did not agree to participate in the study
  • Receiving inpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kadriye Sayin Kasar

Aksaray, İlçe Seçiniz, 68100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 26, 2021

Study Start

January 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations