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

NCT04999189 | Unknown

• 1 other identifier: 03/5R-2021
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Assessment of change in self-care

  Self-care in individuals with type 2 diabetes will be assessed using the Self-Care of Diabetes Inventory (SCODI) questionnaire from Ausili et al., 2017. The tool consists of 40 assumptions classified into four dimensions: self-care maintenance (12 assumptions), self-care implementation (8 assumptions), self-care monitoring (9 assumptions), and self-confidence (11 assumptions). The instrument is assessed using the Likert scale, where a higher score represents better self-care. Change in SCODI score will be assessed at the enrolment of the patient followed by the examination in the period of up to 6 months after the enrolment.

  up to 6 months

• Assessment of change in disease perception

  The investigators will use the "Brief Illness Perception Questionnaire" (Brief IPQ) to assess disease perception from authors Broadbent, et al., 2006. The questionnaire provides a rapid assessment of disease perception and measures the patient's cognitive and emotional representations of their disease. The questionnaire contains eight graded questions on a 10-point scale and one open-ended question. The higher the score, the more threatening the individual's view of the disease. Change in Brief IPQ score will be assessed at the enrolment of the patient followed by the examination in the period of up to 6 months after the enrolment.

  up to 6 months

• Frequency of using the mobile application

  The investigators will assess the frequency of use at the first check-up for individuals who will use the application during the research. The questions were partially summarized after the "Video Games Preference Inventory" survey questionnaire from authors Kenny \& McDaniel, 2011. In its primary form, the survey questionnaire consists of ten questions. The investigators summarized the first five questions for our research, which the investigators also adapted according to the research content. The questions are rated on the Likert scale (1 = Strongly disagree; 2 = Disagree; 3 = No opinion; 4 = Agree; 5 = Strongly agree). The higher the average rating the user receives, the higher the mobile application level. Frequency of the mobile application use will be collected at the examination in the period of up to 6 months after the enrolment.

  up to 6 months

• Change in body weight

  The registered nurse will measure the patient's body weight with the help of a calibrated technique before the start of the research and at the first examination. The investigators are interested in whether the use of the mobile application will have an effect on weight loss.

  up to 6 months

• Change in glycated hemoglobin

  The registered nurse will measure the patient's glycated hemoglobin with the help of a calibrated glycated hemoglobin monitor before the start of the research and at the first check-up. The investigators will be able to see if the glycated hemoglobin level has decreased in the time before the examination until the first examination. Recommended target HbA1c is less than 7%.

  up to 6 months

• Change in blood sugar

  The registered nurse will measure the patient's blood sugar with the help of a calibrated blood sugar monitor before the start of the research and at the first check-up. The investigators will be able to see if the blood sugar level has decreased in the time before the examination until the first examination.

  up to 6 months

• Change in blood pressure

  The registered nurse will measure the patient's blood pressure with the help of a calibrated blood pressure monitor before the start of the research and at the first check-up. Based on the American Heart Association, these values can be divided into categories (Normal = systolic less than 120, and diastolic less than 80; elevated = systolic between 120 and 129, and diastolic less than 80; hypertension stage 1 = systolic between 130, and 139, or diastolic between 80, and 89; hypertension stage 2 = systolic 140 or higher, or diastolic 90 or higher; hypertension stage 3 = systolic higher than 180, and/or diastolic higher than 120).

  up to 6 months

Study Arms (2)

Patients using mobile applications

EXPERIMENTAL

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

Other: Mobile app forDiabetes (Tessera Multimedia, 2020)

Control group

NO INTERVENTION

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

Interventions

Mobile app forDiabetes (Tessera Multimedia, 2020) OTHER

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

Patients using mobile applications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Maribor: lead

Related Publications (2)

• 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.

  PMID: 16731240 BACKGROUND

• 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.

  PMID: 35713944 DERIVED

Related Links

• Tessera Multimedia, 2020. forDiabetes: diabetes self-management app. \[Online\] Google Play Store.
• 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.
• American Heart Association. What do your blood pressure numbers mean?

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Chronic Disease; Health Behavior; Cell Phone Use

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Communication; Social Behavior

Study Officials

• Lucija Gosak

  University of Maribor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucija Gosak

CONTACT

+386 2 300 47 35; lucija.gosak2@um.si

Gregor Stiglic, PhD

CONTACT

+386 41 660 097; gregor.stiglic@um.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be possible as participants will know to which group they are assigned. The medical staff will also know this as they will teach them how to use the mobile app.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 10, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share