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

October 24, 2023 updated by: Luxembourg Institute of Health

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Strassen, Luxembourg, 1445
        • Luxembourg Institute of Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diabetes clinic and diabetes patient association

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes
Time Frame: At baseline
Diabetes distress and e-health literacy will be described with a validated self-reported scale
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxembourg Institute of Health

Investigators

  • Principal Investigator: Guy A Fagherazzi, PhD, Luxembourg Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2022

Primary Completion (Actual)

May 2, 2023

Study Completion (Actual)

May 2, 2023

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSYVOICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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