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

NCT05329376 | Completed

• 1 other identifier: 20220311
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Change from baseline to 12 weeks

Secondary Outcomes (7)

• Glycemic control: glycated hemoglobin (HbA1c) assessment

  Change from baseline to 12 weeks

• Variation in systolic blood pressure

  Change from baseline to 12 weeks

• Variation in diastolic blood pressure

  Change from baseline to 12 weeks

• Variation in total cholesterol

  Change from baseline to 12 weeks

• Adherence parameters and self-care in the treatment of diabetes

  Change from baseline to 12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®).

Device: Smart Speaker Echo Dot

Group B

OTHER

12 weeks of maintenance of usual care.

Other: Usual Care

Interventions

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: 1. Medication reminders 2. Glucose test reminders: 3. Educational health tips 4. Weekly educational podcasts 5. Good morning and good night routine

Group A

Usual Care OTHER

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

Group B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead

Study Sites (1)

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 41575748 DERIVED

• 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.

  PMID: 38515201 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Anxiety Disorders; Mental Disorders; Frailty

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 15, 2022
• Study Start: June 20, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

BR (1)