An interventional study of Smart Speaker Echo Dot and Usual Care in Diabetes Mellitus, Type 2, Depression, Anxiety and Mental Health Disorder, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Supportive care
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Among 316 studies in Diabetes Mellitus, Type 2 with a site in Brazil — 36 open to participants now, 44 under way, 22 of them phase 3. Diabetes Mellitus, Type 2 · Brazil.
Among the 316 studies in Diabetes Mellitus, Type 2 with a site in Brazil, this one is the 189th largest by enrollment of the 295 interventional ones that give a count, is one of 10 that started in 2023, is one of 82 with no phase, and was the 255th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →36 of the 316 studies in Diabetes Mellitus, Type 2 with a site in Brazil are open now. Recruiting first, the newest first:
Universidade Sao Francisco · Sites in Brazil
Ages 40–80 · Healthy volunteers
Eli Lilly and Company · Sites in Brazil, United States, China and 7 more countries
Ages 18+
AstraZeneca · Sites in Brazil, United States, Argentina and 8 more countries
Ages 18+
Novo Nordisk A/S · Sites in Brazil, United States, Argentina and 13 more countries
Ages 45+
Novo Nordisk A/S · Sites in Brazil, United States, Argentina and 7 more countries
Ages 10–18
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
316 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 19 · Phase 3 151 · Phase 4 37
First in 2002; this study’s year is marked. 10 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 112 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 326 across the 295 interventional studies, 90 across the 21 observational. Of the 239 that completed or were terminated, 116 (49%) have results posted.
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196 of 316 have an industry lead sponsor. The 10 most frequent:
Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Pontificia Universidade Católica do Rio Grande do Sul has 1 study filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
5 of the studies in Diabetes Mellitus, Type 2 with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03811561Phase 3Novo Nordisk A/SA Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes | 2027-11-07 |
| NCT07463859University of Sao PauloEffects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus | 2027-01-31 |
| NCT07606066AstraZenecaA Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies | 2027-03-31 |
| NCT06735859Federal University of São PauloEating Window and Sleep Disorders on Glycemic Control, Cardiovascular Risk, and Weight Loss | 2027-06 |
| NCT07846319epHealthEvaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality | 2027-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 316 studies in Diabetes Mellitus, Type 2 with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Recruitment:
Study subjects will be recruited through two different strategies:
12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®).
Device: Smart Speaker Echo Dot
12 weeks of maintenance of usual care.
Other: Usual Care
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: 1. Medication reminders 2. Glucose test reminders: 3. Educational health tips 4. Weekly educational podcasts 5. Good morning and good night routine
Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment
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.
Time frame: Change from baseline to 12 weeks
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.
Time frame: Change from baseline to 12 weeks
Variation in systolic blood pressure
Systolic blood pressure assessment (mmHg)
Time frame: Change from baseline to 12 weeks
Variation in diastolic blood pressure
Diastolic blood pressure assessment (mmHg)
Time frame: Change from baseline to 12 weeks
Variation in total cholesterol
Total cholesterol (mg/dL)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 12 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in May 2024, 10 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 10 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Pontificia Universidade Católica do Rio Grande do Sul