The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care

NCT ID: NCT04999189

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-01

Brief Summary

The purpose of the research is to evaluate and test the usefulness of the mobile application forDiabetes to improve the self-care of individuals with diabetes type 1. The investigators want to obtain the missing evidence from the field of application operation and their impact on individuals' self-care and study the acceptance of applications among healthcare staff, which plays an essential role in patient education.

Detailed Description

The investigators will conduct a randomized study in which individuals included in the intervention group will use the forDiabetes app to self-care for their type 2 diabetes throughout the study. A randomized controlled trial will be conducted in family medicine clinics throughout Slovenia. At the start of the observation and the first control visit, the investigators will assess self-care and disease perception of individuals with the help of validated questionnaires. Measurement of body weight, blood pressure, blood sugar monitoring, and glycated hemoglobin will also be performed at the observation and a first control visit. For individuals who will use the forDiabetes application during the research, the investigators will also assess the frequency of using the mobile application in the home environment at the first control visit.

Conditions

Type 2 Diabetes; Diabetes Mellitus, Type 2; Disease, Chronic; Self-Care; Health Behavior; Mobile Apps; Mobile Phone Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients using mobile applications

Patients diagnosed with type 2 diabetes will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.

Group Type: EXPERIMENTAL

Mobile app forDiabetes (Tessera Multimedia, 2020)

Intervention Type: OTHER

Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.

Control group

Patients will receive treatment from medical staff (as usual).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile app forDiabetes (Tessera Multimedia, 2020)

Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients older than 18 years;
• with regulated and diagnosed type 2 diabetes;
• patients who are managed in a family medicine clinic;
• patients who have the option of using a mobile phone and a blood sugar meter in the home environment.

Exclusion Criteria

• patients diagnosed with type 1 diabetes;
• patients who have chronic complications as a result of diabetes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Maribor

OTHER

Sponsor Role: lead

Responsible Party

Lucija Gosak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucija Gosak

Role: PRINCIPAL_INVESTIGATOR

University of Maribor

Central Contacts

Lucija Gosak

Role: CONTACT

lucija.gosak2@um.si

+386 2 300 47 35

Gregor Stiglic, PhD

Role: CONTACT

gregor.stiglic@um.si

+386 41 660 097

References

Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

Reference Type: BACKGROUND

PMID: 16731240 (View on PubMed)

Gosak L, Pajnkihar M, Stiglic G. The Impact of Mobile Health Use on the Self-care of Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 17;11(6):e31652. doi: 10.2196/31652.

Reference Type: DERIVED

PMID: 35713944 (View on PubMed)

Related Links

https://play.google.com/store/apps/details?id=gr.tessera.fordiabetesapp&hl=en&gl=US

Tessera Multimedia, 2020. forDiabetes: diabetes self-management app. \[Online\] Google Play Store.

https://bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-017-0218-y

Ausili, D., et al., 2017. Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory. BMC Endocrine Disorders, 17(1), pp. 66.

https://www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings

American Heart Association. What do your blood pressure numbers mean?

Other Identifiers

03/5R-2021

Identifier Type: -

Identifier Source: org_study_id