Clinical trial NCT04999189: The Effectiveness of Using a Mobile Application for Type 2 Diabetes Self-care
Official title: Effectiveness of Using a Mobile Self-care Application in the Management of a Patient With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Diabetes Mellitus, Type 2
Disease, Chronic
Self-Care
Health Behavior
Mobile Apps
Mobile Phone Use
Lead sponsor: University Maribor
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Assessment of change in self-care
timeFrame: up to 6 months
measure: Assessment of change in disease perception
timeFrame: up to 6 months
measure: Frequency of using the mobile application
timeFrame: up to 6 months
measure: Change in body weight
timeFrame: up to 6 months
measure: Change in glycated hemoglobin
timeFrame: up to 6 months
measure: Change in blood sugar
timeFrame: up to 6 months
measure: Change in blood pressure
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Maribor
name: Lucija Gosak
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.