Clinical trial NCT05517772: Expectations of People With Type 1 Diabetes About Voice-based Interventions to Support Diabetes Distress Management
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: type1diabetes
Diabetes Distress
Keywords: type 1 diabetes
diabetes distress
voice technology
depression
anxiety
quality of life
digital health
vocal biomarkers
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
First posted: 2022-08-26
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes clinic and diabetes patient association

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Semi-structured interviews
timeFrame: At baseline
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: At baseline
Other outcomes:
Locations:
city: Strassen
country: Luxembourg
facility: Luxembourg Institute of Health
Study officials:
affiliation: Luxembourg Institute of Health
name: Guy A Fagherazzi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.