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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
Pontificia Universidade Católica do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 14, 2022
    Last Updated
    June 5, 2023
    Sponsor
    Pontificia Universidade Católica do Rio Grande do Sul
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    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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