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Completed

NCT Number: NCT05517772

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

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.

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Key information

About this study

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:

  • 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).
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women with a Type 1 diabetes diagnosis /caregivers of children diagnosed with T1D
  • Able to speak and read in English, German, or French.

Exclusion criteria

Unwilling or unable to participate in online interviews.

Treatment and study plan

Primary outcomes

  1. Semi-structured interviews

    Time frame: At baseline

    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.

Secondary outcomes

  1. Patient reported outcomes

    Time frame: At baseline

    Diabetes distress and e-health literacy will be described with a validated self-reported scale

Sponsors and collaborators

Lead sponsor

Luxembourg Institute of Health

Other Gov

Registry information

Official study 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

Acronym: PSYVOICE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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