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

Not Applicable

Completed

• Conditions: Old Age; Debility; Diabetes Mellitus, Type 2; Depression, Anxiety; Mental Health Disorder
• Interventions: Device: Smart Speaker Echo Dot; Other: Usual Care

• Registration Number: NCT05329376
• Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2023-06-20
• Status Verified: 2024-03
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Smart Speaker Echo Dot	12 weeks of daily interactions with Smart Speaker EchoDot 3rd Gen (Amazon Echo®).
Group B	Usual Care	12 weeks of maintenance of usual care.

Primary Outcome Measures

Name	Time	Method
Screening for depression, anxiety and common mental health disorders in elderly	Change from baseline to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Variation in diastolic blood pressure	Change from baseline to 12 weeks	Diastolic blood pressure assessment (mmHg)
Variation in systolic blood pressure	Change from baseline to 12 weeks	Systolic blood pressure assessment (mmHg)
Adherence parameters and self-care in the treatment of diabetes	Change from baseline to 12 weeks	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.
Perception of stress:	Change from baseline to 12 weeks	Quality of Life will be assessed at baseline and after 12 weeks using the Perceived Stress Scale (PSS) questionnaire.
Glycemic control: glycated hemoglobin (HbA1c) assessment	Change from baseline to 12 weeks	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.
Variation in total cholesterol	Change from baseline to 12 weeks	Total cholesterol (mg/dL)
Evaluation of quality of life	Change from baseline to 12 weeks	Quality of Life will be assessed at baseline and after 12 weeks using the Short Form Health Survey (SF-36) questionnaire.

Trial Locations

Locations (1)

Pontifícia Universidade Católica do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil