Evidence map›Paper›PMID 38515201›Full record

ArticleTrials2024

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.

Frederico Ludwig da Costa, Lucas Strassburger Matzenbacher, Vicenzo Gheno, Maria Antônia Bertuzzo Brum, Laura Gomes Boabaid de Barros, Isabela Semmelmann Maia, Luiza Machado Blank, Lucas Friedrich Fontoura, Janine Alessi, Gabriela Heiden Telo

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05329376 (Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05329376 nacompletednot on this map

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

TypeinterventionalSponsorPontificia Universidade Católica do Rio Grande do SulRan2023 to 2024Enrolled112ConditionsDiabetes Mellitus, Type 2, Depression, Anxiety, Mental Health Disorder, Old AgeArmsSmart Speaker Echo Dot, Usual Care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
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  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Frederico Ludwig da Costa *Post-Graduate Program in Medicine and Health Sciences, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Lucas Strassburger Matzenbacher *School of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Vicenzo GhenoSchool of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Maria Antônia Bertuzzo BrumSchool of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Laura Gomes Boabaid de BarrosSchool of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Isabela Semmelmann MaiaSchool of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Luiza Machado BlankSchool of Medicine, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Lucas Friedrich FontouraPost-Graduate Program in Medicine and Health Sciences, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Janine AlessiInternal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
Gabriela Heiden TeloInternal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil. gabriela.telo@pucrs.br.
Pontifícia Universidade Católica do Rio Grande do Sul · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico CNPq/MCTI/FNDCT 18/2021Coordenação de Aperfeiçoamento de Pessoal de Nível Superior finance code 001
6 · The paper itself

Abstract

backgroundWith 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.

methodsThis 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 registrationClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.

Indexed as

Diabetes Mellitus, Type 2Mental DisordersAgedHealth PromotionHumansPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicSelf CareAlexaElderlyHealthy aging

Identifiers

PMID38515201
PMCPMC10956275
OpenAlexW4393054938

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.