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

NCT ID: NCT05329376

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-05-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Smart Speaker Echo Dot

Intervention Type: 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 B

12 weeks of maintenance of usual care.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

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

Interventions

Smart Speaker Echo Dot

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

Intervention Type: DEVICE

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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®

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 38515201 (View on PubMed)

Other Identifiers

20220311

Identifier Type: -

Identifier Source: org_study_id