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Completed

NCT Number: NCT05329376

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Diabetes Mellitus Endocrine System Diseases Frailty Glucose Metabolism Disorders Mental Disorders Mental Health Disorder Metabolic Diseases Nutritional and Metabolic Diseases Old Age; Debility Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Smart Speaker Echo Dot

Device

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

Usual Care

Other

Participants will maintain usual care during the study period and will receive a booklet with general advice following enrollment

Primary outcomes

  1. Screening for depression, anxiety and common mental health disorders in elderly

    Time frame: Change from baseline to 12 weeks

    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.

Secondary outcomes

  1. Glycemic control: glycated hemoglobin (HbA1c) assessment

    Time frame: Change from baseline to 12 weeks

    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.

  2. Variation in systolic blood pressure

    Time frame: Change from baseline to 12 weeks

    Systolic blood pressure assessment (mmHg)

  3. Variation in diastolic blood pressure

    Time frame: Change from baseline to 12 weeks

    Diastolic blood pressure assessment (mmHg)

  4. Variation in total cholesterol

    Time frame: Change from baseline to 12 weeks

    Total cholesterol (mg/dL)

  5. Adherence parameters and self-care in the treatment of diabetes

    Time frame: Change from baseline to 12 weeks

    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.

  6. Evaluation of quality of life

    Time frame: Change from baseline to 12 weeks

    Quality of Life will be assessed at baseline and after 12 weeks using the Short Form Health Survey (SF-36) questionnaire.

  7. Perception of stress:

    Time frame: Change from baseline to 12 weeks

    Quality of Life will be assessed at baseline and after 12 weeks using the Perceived Stress Scale (PSS) questionnaire.

Sponsors and collaborators

Lead sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2022
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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