Clinical trial NCT05329376: Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
Official title: Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Depression, Anxiety
Mental Health Disorder
Old Age; Debility
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 112
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion:

* 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®

Primary outcomes:
measure: Screening for depression, anxiety and common mental health disorders in elderly
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Glycemic control: glycated hemoglobin (HbA1c) assessment
timeFrame: Change from baseline to 12 weeks
measure: Variation in systolic blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Variation in diastolic blood pressure
timeFrame: Change from baseline to 12 weeks
measure: Variation in total cholesterol
timeFrame: Change from baseline to 12 weeks
measure: Adherence parameters and self-care in the treatment of diabetes
timeFrame: Change from baseline to 12 weeks
measure: Evaluation of quality of life
timeFrame: Change from baseline to 12 weeks
measure: Perception of stress:
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pontifícia Universidade Católica do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
References: