Impact Evaluation of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus (T2DM): Pilot Study NOVAME

Study Overview
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Brief Summary
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The objective of this project is to evaluate the effectiveness and cost effectiveness of a health app (NOVAME) designed to improve the self-control of patients with T2DM and their health outcomes. The central focus of NOVAME is the continuous support to the patient and monitoring through the app that will act as a personalized and dynamic virtual coach that will help the patient to adopt healthy habits and change their behaviors through training plans in different areas: exercise physical, healthy eating, therapeutic education and emotional management The design of the evaluation is the randomized clinical trial, in the intervention arm patients will use the app NOVAME and in the control group, patients don't receive any additional educational or supporting activities beyond the usual activities provided by the Canary Islands Health Service (CIHS). The main outcome measure is the change in HbA1c at 3 months, requiring a total of 197 patients to detect a difference of at least 0.4% considering a 10% loss. As secondary measures HbA1c is collected at 12 months and other biochemical results (lipids and glucose), BMI and a series of questionnaires to measure changes in life habits (diet, physical activity), anxiety and depression, knowledge about their disease , degree of empowerment, satisfaction and usability of the app, .. Will be collected at 3 and 12 months. The differences between the arms will be measured with mixed generalized linear models. The cost effectiveness will be calculated by calculating life years adjusted for quality (QALY) and the cost of the disease, including the use of resources reported by patients. The benefits of the technology will be expressed in terms of HbA1c and QALY.

Official Title
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Evaluation of the Impact of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus: Pilot Study NOVAME

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: mobile app NOVAME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with T2DM diagnosed at least one year prior to study enrolment 18-65 years of age Formal consent to participate in the study Regular use of mobile phone Exclusion Criteria: Chronic kidney disease≥stage 3b, as defined by the National Kidney Foundation's Kidney Disease Outcomes and Quality Improvement Initiative (KDOQI); urinary albumin to creatinine ratio (UACR) ≥ 300 mg/g and/or urinary protein excretion ≥ 300 mg/24 hours. Acute coronary syndrome (documented angina or myocardial infarction) or stroke in the last six months or class III or IV heart failure, according to the New York Heart Association (NYHA). Proliferative diabetic retinopathy or clinically significant diabetic macular edema requiring previous treatment with retinal photocoagulation, vitrectomy, or intravitreal injections of antivascular endothelial growth factor or triamcinolone acetonide 6 months prior to study inclusion. Uncorrected severe hearing or visual impairment; or corrected visual acuity ≤ 20/40 by any cause. Diabetic foot with ulcers ≥ 2 according to Wagner scale. Liver cirrhosis Cancer unless disease free five years after diagnosis Other terminal illnesses Intellectual retardation, dementia, psychotic diseases. Active substance abuse, alcohol or drugs (must be sober for one year) Pregnancy Insufficient (Spanish) language skills Physical disability limiting participation in group education activities Concurrent participation in another clinical trial or any other investigational study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: health mobile app for T2DM patients<br>It consists of a mobile app that will be provided to patients during a period of 12 months, the patient can also continue with the usual care. The application will be synchronized with a server where all the information is recorded for further analysis. The central focus of the application consists of continuous support and monitoring through the app that has a personalized and dynamic virtual coach that will help the patient to adopt healthy habits and change their behaviors through training plans in different areas: exercise physical, healthy eating, therapeutic education and emotional management | Behavioral: mobile app NOVAME<br>* The training program is divided into 3 periods of 21 days, where each day the patient receives a new formation pill. At the end of one of these periods there will be a week of review in which the patient will receive reminders of the contents that he has already received. These pills will help the patient to acquire healthy lifestyle habits and improve the control of the disease. The length of the program is 84 days, and once completed, the patient can repeat or intensify efforts in the areas he considers and continue to have access to the virtual coach. Patients assigned to the intervention group will receive a brief structured explanation on how to use the application and its contents.<br>|
| No Intervention: Control<br>Receives the usual care as established in the Canary Islands Atherosclerotic Vascular Disease Prevention and Control Program (EVA) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | glycosylated hemoglobin | Baseline, 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol and its fractions (LDL, HDL and nonHDL), and triglycerides | triglycerides, Total Cholesterol, LDL Cholesterol, HDL Cholesterol | Baseline, 3 months, 12 months | 
| Glucose | glucose level | Baseline, 3 months, 12 months | 
| BMI | Body mass index | Baseline, 3 months, 12 months | 
| Quality of life related to health | EQ-5D-5L questionnaire. The EQ-5D is a generic instrument of HRQL measurement where the individual assesses their state of health, first in levels of severity by dimensions (descriptive system) and then in a visual analogue scale (VAS) of more general evaluation. The index ranges between the value 1 (best health status) and 0 (death), although there are negative values for the index, corresponding to health status that are valued as worse than death. | Baseline, 3 months, 12 months |