Expectations of People With Type 1 Diabetes About Voice-based Interventions to Support Diabetes Distress Management

type1diabetes Clinical Trial

— PSYVOICE  

Official title:

The Voice of Diabetes: A Mixed-methods Study on the Needs of People With Type 1 Diabetes and Their Caregivers to Co-design a Voice-based Digital Health Solution to Support Diabetes Distress Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517772
• Other study ID #: PSYVOICE
• Status: Completed
• Start date: June 16, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: October 2023
• Source: Luxembourg Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study explores the perspectives and needs of people dealing with type 1 diabetes or their carers to co-design a voice-based digital health intervention for supporting diabetes distress management.

Description:

New technologies restore people with type 1 diabetes to a certain degree of independence and control over their lives while allowing medical providers to keep an overview of their patient's general health conditions and the evolution of their treatments. Notably, solutions integrating voice-processing technology appeared to be encouraging alternatives for remote monitoring. Diabetes distress is a common condition in people living with type 1 diabetes. Diabetes distress is associated with poor metabolic control and low quality of life. Because voice analysis involves highly complex methods for processing audio features, this kind of development might also be capable of detecting subtle changes associated with psychological factors, like diabetes distress. Nevertheless, digital health incorporation into the everyday lives of potential users might also imply a big challenge for many of them. For this reason, studying the needs of the end-users of technological tools before defining any aspect of their design has become a critical step in developing this kind of technology. The main objective of Psyvoice is to identify the preferences of people living with type 1 diabetes for voice-based digital health solutions for diabetes distress detection and control. Secondary objectives are: 1. Delineating the properties that an instrument for diabetes distress management must incorporate to be considered adequate by its intended users (e.g. single voice-analysis function exclusively for diabetes distress management vs multiple functions or multiple uses). 2. Determining the attributes (e.g. frequency of use) that could make a digital health solution prone to be integrated by its end-users into their everyday lives. 3. Defining the characteristics likely to make a digital health solution acceptable. These are privacy and security concerns, barriers of use (difficulties with technology, disability) and facilitators of use (technical support, use of plain language). To achieve all of these objectives, the investigators will conduct in-depth interviews. The study will combine qualitative and quantitative methods. The investigators will invite twenty people with a T1D diagnosis or caregivers of children diagnosed with this condition to participate in semi-structured in-depth interviews and questionnaires. The questionnaires will be composed of a Socio-demographic, an e-Health Literacy (eHLQ) questionnaire, and a Diabetes Distress (PAID) scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. Men or women with a Type 1 diabetes diagnosis /caregivers of children diagnosed with T1D

2. Able to speak and read in English, German, or French. Exclusion Criteria: Unwilling or unable to participate in online interviews.

Related Conditions & MeSH terms

• Diabetes Distress
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Locations

Country	Name	City	State
Luxembourg	Luxembourg Institute of Health	Strassen

Sponsors (1)

Lead Sponsor	Collaborator
Luxembourg Institute of Health

Country where clinical trial is conducted

Luxembourg, 

References & Publications (4)

Fagherazzi G, Fischer A, Ismael M, Despotovic V. Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice. Digit Biomark. 2021 Apr 16;5(1):78-88. doi: 10.1159/000515346. eCollection 2021 Jan-Apr. — View Citation

Hart RI, Kimbell B, Rankin D, Allen JM, Boughton CK, Campbell F, de Beaufort C, Frohlich-Reiterer E, Ware J, Hofer SE, Kapellen TM, Rami-Merhar B, Thankamony A, Hovorka R, Lawton J; KidsAP Consortium. Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Diabet Med. 2022 Jul;39(7):e14828. doi: 10.1111/dme.14828. Epub 2022 Mar 24. — View Citation

Kiriella DA, Islam S, Oridota O, Sohler N, Dessenne C, de Beaufort C, Fagherazzi G, Aguayo GA. Unraveling the concepts of distress, burnout, and depression in type 1 diabetes: A scoping review. EClinicalMedicine. 2021 Aug 28;40:101118. doi: 10.1016/j.eclinm.2021.101118. eCollection 2021 Oct. — View Citation

Mathiesen AS, Thomsen T, Jensen T, Schiotz C, Langberg H, Egerod I. The influence of diabetes distress on digital interventions for diabetes management in vulnerable people with type 2 diabetes: A qualitative study of patient perspectives. J Clin Transl Endocrinol. 2017 Jul 11;9:41-47. doi: 10.1016/j.jcte.2017.07.002. eCollection 2017 Sep. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semi-structured interviews	Analyzing semi-structured interviews using a qualitative research methods approach will allow extracting the themes that matter for people when expressing preferences regarding digital voice technology.	At baseline
Secondary	Patient reported outcomes	Diabetes distress and e-health literacy will be described with a validated self-reported scale	At baseline