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Diabetes Mellitus, Type 2NCT05329376

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

A study testing Smart Speaker Echo Dot in people with Diabetes Mellitus, Type 2 and Depression, Anxiety, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Smart Speaker Echo Dot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteBrazil
Study dates
20 Jun 2023to 17 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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®

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Pontifícia Universidade Católica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90619-900

Other trials in Brazil

About this study

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.

Being tested
Smart Speaker Echo Dot, Usual Care
Medical subject headings
Diabetes Mellitus, Type 2, Depression, Anxiety Disorders, Mental Disorders, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart Speaker Echo DotDevice

    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

  • Usual CareOther

    Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment

Study groups in NCT05329376
Study groupRoleWhat they receive
Group AExperimental12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®).
Receives: Device: Smart Speaker Echo Dot
Group BOther12 weeks of maintenance of usual care.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline to 12 weeks

Secondary outcomes (7)

  1. 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.

    Measured: Change from baseline to 12 weeks

  2. Variation in systolic blood pressure

    Systolic blood pressure assessment (mmHg)

    Measured: Change from baseline to 12 weeks

  3. Variation in diastolic blood pressure

    Diastolic blood pressure assessment (mmHg)

    Measured: Change from baseline to 12 weeks

  4. Variation in total cholesterol

    Total cholesterol (mg/dL)

    Measured: Change from baseline to 12 weeks

  5. 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.

    Measured: Change from baseline to 12 weeks

  6. 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.

    Measured: Change from baseline to 12 weeks

  7. Perception of stress:

    Quality of Life will be assessed at baseline and after 12 weeks using the Perceived Stress Scale (PSS) questionnaire.

    Measured: Change from baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start20 Jun 2023
  3. Primary completion17 May 2024
  4. Study completion17 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329376
Sponsor's protocol ID
20220311
Status last verified
Mar 2024
First submitted
14 Mar 2022
Last updated
22 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 41575748

  • 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.

    PubMed 38515201

Questions about this trial

What is this clinical trial studying?

A study testing Smart Speaker Echo Dot in people with Diabetes Mellitus, Type 2 and Depression, Anxiety, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Screening for depression, anxiety and common mental health disorders in elderly (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329376, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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