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BACKGROUD: Health technology is an important tool in the aging process, which may improve the health condition and self-esteem of the elderly, in addition to offering new opportunities and challenges. In this scenario, the use of virtual interaction systems emerge as promising alternatives for the old adults, which often deals with the lack of social interaction, cognitive decline and decline in functional capacity, making the control of chronic diseases, such as diabetes, a challenge.
OBJECTIVES: This project aims to evaluate the effectiveness of using an interactive virtual assistance system in mental health parameters, glycemic profile and diabetes selfcare behavior in elderly people with diabetes.
METHODS: A randomized clinical trial is proposed, for an intervention that includes 3 months of use of the Smart Speaker Echo Dot system, programmed to provide reminders, stimulate treatment records and maintain healthy habits. Outcomes assessed will include parameters of mental health and diabetes control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®). |
|
| Group B | Other | 12 weeks of maintenance of usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Speaker Echo Dot | Device | Participants will receive the Smart Speaker EchoDot 3rd Gen (Amazon Echo®) device (i.e., Alexa) for home use, installed during a home visit following the study enrollment. In addition to the usual functionality of the system, the device will be programmed using a standard model developed by the research team, applied to each patient. The proposed model involves automatic interactions between the device and the patient, comprising:
|
| Measure | Description | Time Frame |
|---|---|---|
| Screening for depression, anxiety and common mental health disorders in elderly | For mental health screening, the Self Report Questionnaire (SRQ 20) will be used, translated into Portuguese and validated for the Brazilian population. It is a questionnaire with 20 questions specially developed for the screening of depression, anxiety em common mental health disorders in the elderly. Higher scores indicating more mental distress. | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control: glycated hemoglobin (HbA1c) assessment | To assess glycemic control, the dosage of glycated hemoglobin (HbA1c) will be performed by high performance liquid chromatography, a measure that estimates the average glycemic control of the three months before the exam. | Change from baseline to 12 weeks |
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Inclusion:
Exclusion:
Recruitment:
Study subjects will be recruited through two different strategies:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PontifÃcia Universidade Católica do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90619-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41575748 | Derived | Matzenbacher LS, da Costa FL, de Barros LGB, Gheno V, Maia IS, Blank LM, Brum MAB, Fontoura LF, Viola TW, Schwanke CHA, Gadonski G, Alessi J, Telo GH. Interactive Virtual Assistant for Health Promotion Among Older Adults With Type 2 Diabetes: The IVAM-ED Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2553508. doi: 10.1001/jamanetworkopen.2025.53508. | |
| 38515201 |
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| Usual Care | Other | Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment |
|
| Variation in systolic blood pressure |
Systolic blood pressure assessment (mmHg) |
| Change from baseline to 12 weeks |
| Variation in diastolic blood pressure | Diastolic blood pressure assessment (mmHg) | Change from baseline to 12 weeks |
| Variation in total cholesterol | Total cholesterol (mg/dL) | Change from baseline to 12 weeks |
| Adherence parameters and self-care in the treatment of diabetes | To assess adherence and self-care related to diabetes, the Self-Care Inventory Revised (SCI-R) questionnaire will be used, a version translated into Portuguese and validated for the Brazilian population. It is a questionnaire with 11 questions and answer options based on the 5-point Likert scale and which reflects the follow-up of treatment recommendations and lifestyle habits related to diabetes care in the2 months prior to the application. Higher scores reflect greater adherence and self-care. | Change from baseline to 12 weeks |
| Evaluation of quality of life | Quality of Life will be assessed at baseline and after 12 weeks using the Short Form Health Survey (SF-36) questionnaire. | Change from baseline to 12 weeks |
| Perception of stress: | Quality of Life will be assessed at baseline and after 12 weeks using the Perceived Stress Scale (PSS) questionnaire. | Change from baseline to 12 weeks |
| da Costa FL, Matzenbacher LS, Gheno V, Brum MAB, de Barros LGB, Maia IS, Blank LM, Fontoura LF, Alessi J, Telo GH. Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial. Trials. 2024 Mar 21;25(1):205. doi: 10.1186/s13063-024-08055-3. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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