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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05517772
Acronym
PSYVOICE
Enrollment
12
Registered
2022-08-26
Start date
2022-06-16
Completion date
2023-05-02
Last updated
2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Distress, type1diabetes

Keywords

type 1 diabetes, diabetes distress, voice technology, depression, anxiety, quality of life, digital health, vocal biomarkers

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Luxembourg Institute of Health
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Semi-structured interviewsAt baselineAnalyzing 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.

Secondary

MeasureTime frameDescription
Patient reported outcomesAt baselineDiabetes distress and e-health literacy will be described with a validated self-reported scale

Countries

Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026