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Clinical Trials/NCT05329376
NCT05329376
Completed
Not Applicable

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

Pontificia Universidade Católica do Rio Grande do Sul1 site in 1 country112 target enrollmentJune 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Enrollment
112
Locations
1
Primary Endpoint
Screening for depression, anxiety and common mental health disorders in elderly
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2023
End Date
May 17, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Screening for depression, anxiety and common mental health disorders in elderly

Time Frame: 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 Outcomes

  • Variation in diastolic blood pressure(Change from baseline to 12 weeks)
  • Variation in systolic blood pressure(Change from baseline to 12 weeks)
  • Adherence parameters and self-care in the treatment of diabetes(Change from baseline to 12 weeks)
  • Perception of stress:(Change from baseline to 12 weeks)
  • Glycemic control: glycated hemoglobin (HbA1c) assessment(Change from baseline to 12 weeks)
  • Variation in total cholesterol(Change from baseline to 12 weeks)
  • Evaluation of quality of life(Change from baseline to 12 weeks)

Study Sites (1)

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