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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05329376
• Other study ID #: 20220311
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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®

Related Conditions & MeSH terms

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

Intervention

Device:
• 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: Medication reminders Glucose test reminders: Educational health tips Weekly educational podcasts Good morning and good night routine

Other:
• Usual Care
Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment

Locations

Country	Name	City	State
Brazil	Pontifícia Universidade Católica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

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