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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| health mobile app for T2DM patients | Active Comparator | 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 |
|
| Control | No Intervention | Receives the usual care as established in the Canary Islands Atherosclerotic Vascular Disease Prevention and Control Program (EVA) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile app NOVAME | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | glycosylated hemoglobin | Baseline, 3 months, 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Evaluación. Servicio Canario de Salud | Santa Cruz de Tenerife | 38004 | Spain |
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Researchers who recruited participants and applied the baseline and 3-month questionnaires were not blinded to the allocation sequence. Given the nature of the intervention patients could not be blinded
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| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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