Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients

June 24, 2023 updated by: Nermin Kılıç Barmanpek, Inonu University

The Effect of Motivational Interview Empowered by Mobile Technology on Self Management, Quality of Life and Satisfaction Level in Type 2 Diabetic Patients

Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.

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

A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.

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.
64

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
    • Centrer
      • Bingöl, Centrer, Turkey
        • Bingöl State Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18 years or older,
  • Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
  • Being on oral antidiabetic and/or insulin therapy,
  • Having a smart phone and knowing how to use it,
  • Internet connection (to install mobile technology application),
  • Not having participated in motivational interviewing (MG) training before,
  • Not having vision and hearing problems,
  • Not having a communication problem,
  • To be able to read, write and speak Turkish,
  • Volunteering to participate in the study and continue the study process.

Exclusion Criteria:

  • Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
  • Having serious health problems that prevent participation in motivational interviewing,
  • Using steroid therapy,
  • Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
  • Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
  • Being unwilling to participate in the study and/or not wanting to continue the study process.

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 Assignment
  • Masking: None (Open Label)

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
Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale (DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test, a educational program and a game-based mobile technology application were carried out for 4 weeks, 2 days a week at intervals. After the educational program were completed, motivational interviews were conducted once a week for 4 weeks. In this process, it was ensured that the game-based mobile technology application continued. Post-test data were collected with DSMQ and SF-36 at 2 months (8 weeks after the pre-test). After the post-test, the patients were followed up for 4 weeks. After the follow, with the Patient Information and Follow-up Form, DSMQ, SF-36, and the Satisfaction Questionnaire the follow-test data was collected.
Behavioral: Patient Education with Game-Based Mobile Technology and Motivational Interviewing
Education program, game-based mobile technology and motivational interview were applied to the patients in the experimental group. The patients' self-management, quality of life, and satisfaction level scores for the intervention were determined.
No Intervention: Control Group
Pre-test data were collected from patients with Patient Information and Follow-up Form, Diabetes Self-Management Scale DSMQ) and Short Form-36 Quality of Life Scale (SF-36). After the pre-test data were collected, no intervention was applied to the patients for 3 months (12 weeks), except for routine nursing care. Posttest data were collected with DSMQ and SF-36 2 months (8 weeks) after the pretest data. After the last test, the patients were followed up for 4 weeks, and 3 months (12 weeks) after the start of the study, the Patient Information and Follow-up Form (only the parts containing the features related to the disease and metabolic control variables), DSMQ and SF-36 Scale and follow-up test data were collected.

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
DSMQ
Time Frame: Last 8 weeks
The scale is of a four-point Likert type. The scale has 4 sub-dimensions as "Glucose Management, Diet Control, Physical Activity, Health-Care Use" and a total score. The lowest score of the scale is 0 points and the highest score is 10 points. The higher the score, the higher the diabetes self-management.
Last 8 weeks
SF-36
Time Frame: Last 4 weeks
The scale consists of 36 items and 8 sub-dimensions. 8 sub-dimensions have 2 summary sub-dimensions as "Physical Health and Mental Health". There is no total score in the scale. A score between 0-100 is evaluated with sub-dimensions (0: Poor Health, 100: Good Health). Low scores on the scale indicate poor health, while high scores indicate good health.
Last 4 weeks

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.
Inonu University

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.
October 6, 2022

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.
February 3, 2023

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.
February 3, 2023

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).
June 13, 2023

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.
June 13, 2023

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.
June 26, 2023

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.
June 27, 2023

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.
June 24, 2023

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.
June 1, 2023

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.
  • Diabetes Mellitus and Mobile

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Can be reviewed by other researchers after the study has been published.

IPD Sharing Time Frame

Data will be shared as long as they are published.

IPD Sharing Access Criteria

Publication Page

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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