Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Depression, Anxiety, Mental Health Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart Speaker Echo Dot
Control group
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
Three months of daily interactions with a voice command virtual interaction system
Three months of maintenance of usual care
Outcomes
Primary Outcome Measures
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. This scale was specially developed for the screening of depression, anxiety em commom mental health disorders in the elderly
Secondary Outcome Measures
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.
Variation in Weight
Weight (in Kg) evaluated by digital scale
Variation in systolic blood pressure
Systolic blood pressure assessment (mmHg)
Variation in diastolic blood pressure
Diastolic blood pressure assessment (mmHg)
Variation in total cholesterol
Total cholesterol (mg/dL)
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 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
Quality of Life will be assessed at baseline and after 12 weeks using the World Health Organization Quality of Life Group - Bred (WHOQOLbref) questionnaire.
Fall episodes
Number of falls
Activities of daily living:
: Katz Activities of Daily Living Index (basic) and Lawton Instrumental Activities of Daily Living Scale (instrumental), baseline and 12w
Perception of stress:
Perceived stress scale baseline and 12w
Full Information
NCT ID
NCT05329376
First Posted
March 14, 2022
Last Updated
June 5, 2023
Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT05329376
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidade Católica do Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Depression, Anxiety, Mental Health Disorder, Old Age; Debility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Three months of daily interactions with a voice command virtual interaction system
Arm Title
Group B
Arm Type
Other
Arm Description
Three months of maintenance of usual care
Intervention Type
Device
Intervention Name(s)
Smart Speaker Echo Dot
Intervention Description
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;
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Participants will maintain usual care during the study period
Primary Outcome Measure Information:
Title
Screening for depression, anxiety and common mental health disorders in elderly
Description
For mental health screening, the Self Report Questionnaire (SRQ 20) will be used, translated into Portuguese and validated for the Brazilian population. This scale was specially developed for the screening of depression, anxiety em commom mental health disorders in the elderly
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Glycemic control: glycated hemoglobin (HbA1c) assessment
Description
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.
Time Frame
Change from baseline to 3 months
Title
Variation in Weight
Description
Weight (in Kg) evaluated by digital scale
Time Frame
Change from baseline at 3 months
Title
Variation in systolic blood pressure
Description
Systolic blood pressure assessment (mmHg)
Time Frame
Change from baseline to 3 months
Title
Variation in diastolic blood pressure
Description
Diastolic blood pressure assessment (mmHg)
Time Frame
Change from baseline to 3 months
Title
Variation in total cholesterol
Description
Total cholesterol (mg/dL)
Time Frame
Change from baseline to 3 months
Title
Adherence parameters and self-care in the treatment of diabetes
Description
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.
Time Frame
Change from baseline to 3 months
Title
Evaluation of quality of life
Description
Quality of Life will be assessed at baseline and after 12 weeks using the World Health Organization Quality of Life Group - Bred (WHOQOLbref) questionnaire.
Time Frame
Change from baseline to 3 months
Title
Fall episodes
Description
Number of falls
Time Frame
Change from baseline to 3 months
Title
Activities of daily living:
Description
: Katz Activities of Daily Living Index (basic) and Lawton Instrumental Activities of Daily Living Scale (instrumental), baseline and 12w
Time Frame
Change from baseline to 3 months
Title
Perception of stress:
Description
Perceived stress scale baseline and 12w
Time Frame
Change from baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
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®
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
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