Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
Study Details
Study Description
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 and glycemic control 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Three months of daily interactions with a voice command virtual interaction system |
Device: Smart Speaker Echo Dot
Participants will receive the Smart Speaker EchoDot (3rd Generation) system in a timely manner based on the day of study enrollment. In addition to the usual functionality of the system, all participants will receive the following interventions through voice commands:
1. Reminders of administration of antidiabetics at the time or period of the day informed in the medical prescription; 2. Check for confirmation of antidiabetic administration 1 hour after the moment of administration; 3. Capillary blood glucose monitoring reminder,when indicated by the attending physician and appropriate; 4. Invitation to perform balance and breathing exercises daily, at a time compatible with the daily schedule provided by the patient at the time of inclusion; 5. Reminder to maintain healthy food choices at times typically associated with meals; 6. Invitation to play activities (eg listening tomusic, dancing, meditating, etc.) daily,according to the daily schedule provided by the patient;
|
| Other: Group B Three months of maintenance of usual care |
Other: Control group
Participants will maintain usual care during the study period
|
Outcome Measures
Primary Outcome Measures
- Screening for depression in elderly [Change from baseline to 3 months]
For depression screening, the Geriatric Depression Scale - 15 (GDS-15) will be used, translated into Portuguese and validated for the Brazilian population. This scale was specially developed for the screening of mood disorders in the elderly,with questions that avoid the sphere of somatic complaints.
- Glycemic control: glycated hemoglobin (HbA1c) assessment [Change from baseline to 3 months]
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.
Secondary Outcome Measures
- Variation in Weight [Change from baseline at 3 months]
Weight (in Kg) evaluated by digital scale
- Variation in systolic blood pressure [Change from baseline to 3 months]
Systolic blood pressure assessment (mmHg)
- Variation in diastolic blood pressure [Change from baseline to 3 months]
Diastolic blood pressure assessment (mmHg)
- Variation in total cholesterol [Change from baseline to 3 months]
Total cholesterol (mg/dL)
- Adherence parameters and self-care in the treatment of diabetes [Change from baseline to 3 months]
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 15 questionsand 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.
- Evaluation of quality of life [Change from baseline to 6 months]
Quality of life will be assessed using the World Health Organization Quality of Life Group - bref (WHOQOL-bref) questionnaire, which consists of 26 questions, two ofwhich are general quality of life questions and assessing 4 main domains: physical,psychological , social relationships and environment. For the study outcome, thetotal inclusion score will be compared with the scores at the end of 3 and 6 months of study.
- Fall episodes [Change from baseline to 6 months]
Number of falls
- Episodes of hypoglycemia (capillary blood glucose <70 mg/dL) [Change from baseline to 6 months]
number of symptomatic or recorded hypoglycemia episodes (capillary blood glucose <70 mg/dL)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Being 65 years of age or older;
-
Having a diagnosis of type 2 diabetes mellitus;
-
Presenting availability of wifi connection at home, availability to participate in theproposed face-to-face evaluations and present autonomy for the administration ofmedicines and basic health self-care;
-
Be willing to interact with the artificial intelligence system for the appropriate evaluation of the proposed intervention
Exclusion Criteria:
-
Type 1 diabetes mellitus
-
Latent autoimmune diabetes of adults (LADA), or early-onset diabetes (MODY)
-
Being hospitalized at the time of enrollment
-
Having an interactive virtual home assistance device at the time of enrollment
-
Having cognitive impairments or severe hearing impairments that prevent adequate interaction with researchers and the application of inclusion and follow-upquestionnaires
-
Residing in regions of difficult access and outside the metropolitan region of Porto Alegre.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pontificia Universidade Católica do Rio Grande do Sul
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220311