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.

Autor: da Costa FL; Post-Graduate Program in Medicine and Health Sciences, 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., Matzenbacher LS; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Gheno V; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Brum MAB; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., de Barros LGB; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Maia IS; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Blank LM; School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Fontoura LF; Post-Graduate Program in Medicine and Health Sciences, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Alessi J; Internal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.; Medicine and Health Sciences Graduate Program, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil., Telo GH; Internal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. gabriela.telo@pucrs.br.; Medicine and Health Sciences Graduate Program, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil. gabriela.telo@pucrs.br.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Mar 21; Vol. 25 (1), pp. 205. Date of Electronic Publication: 2024 Mar 21.
DOI: 10.1186/s13063-024-08055-3
Abstrakt: Background: 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.
Methods: 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.
Discussion: 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.
Trial Registration: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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