Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Depression, Anxiety, Mental Health Disorder, Old Age; Debility

Intervention / Treatment
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* Device: Smart Speaker Echo Dot
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion: Being 65 years of age or older; Having a diagnosis of type 2 diabetes; Residing in Porto Alegre or metropolitan region; Presenting availability of Wi-Fi connection at home; and Presenting availability to participate in the proposed face-to-face evaluation and accept receiving one visit for installation of the device. Exclusion: Having an interactive virtual home assistance device at the time of enrollment; Having cognitive impairments or severe hearing impairments that prevent adequate interaction with outcome assessors and the application of follow-up questionnaires; or Residing in regions of difficult access. Recruitment: Study subjects will be recruited through two different strategies: Screening of records of the outpatients clinics of Hospital São Lucas (HSL) Social media advertising, specially in Instagram®

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®). | Device: Smart Speaker Echo Dot<br>* 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: Medication reminders Glucose test reminders: Educational health tips Weekly educational podcasts Good morning and good night routine<br>|
| Other: Group B<br>12 weeks of maintenance of usual care. | Other: Usual Care<br>* Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |