Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial.

Journal: Trials

Volume: 25

Issue: 1

Year of Publication: 2024

Affiliated Institutions:  Post-Graduate Program in Medicine and Health Sciences, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil. School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil. Internal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. Internal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. gabriela.telo@pucrs.br.

Abstract summary 

With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes.This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes. We plan to enroll a total of 112 individuals who will be randomized 1:1 to receive the Smart Speaker EchoDot 3rd Gen device (Amazon Echo®) for home use (intervention arm) or to maintain usual care (control arm). The primary outcome is mental distress, assessed using the 20-item Self Reporting Questionnaire (SRQ-20) after a 12-week intervention period. Secondary outcomes include quality of life, adherence to diabetes self-care behaviors, perception of stress, glycemic control, blood pressure, and lipid profile. Analysis of covariance (ANCOVA) will be used to evaluate the effects of the intervention on the outcomes.This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population.ClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.

Authors & Co-authors:  da Costa Matzenbacher Gheno Brum de Barros Maia Blank Fontoura Alessi Telo

Study Outcome 

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Statistics
Citations :  United Nations . World Population Prospects 2022. 2022.
Authors :  10
Identifiers
Doi : 205
SSN : 1745-6215
Study Population
Male,Female
Mesh Terms
Aged
Other Terms
Alexa;Elderly;Healthy aging
Study Design
Study Approach
Country of Study
Publication Country
England