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

NCT05517772 | Completed

• 1 other identifier: PSYVOICE
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

type1diabetes; Diabetes Distress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient reported outcomes

  At baseline

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes clinic and diabetes patient association

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to participate in online interviews.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead

Study Sites (1)

Luxembourg Institute of Health

Strassen, 1445, Luxembourg

Location

Related Publications (6)

• 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.

  PMID: 34485879 BACKGROUND

• 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.

  PMID: 29067269 BACKGROUND

• 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.

  PMID: 35274356 BACKGROUND

• 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.

  PMID: 34056518 BACKGROUND

• Aguirre Vergara F, Pinker I, Fischer A, Seuring T, Tichomirowa MA, de Beaufort C, Kamp SM, Fagherazzi G, Aguayo GA. Readiness of adults with type 1 diabetes and diabetes caregivers for diabetes distress monitoring using a voice-based digital health solution: insights from the PsyVoice mixed methods study. BMJ Open. 2025 Jan 2;15(1):e088424. doi: 10.1136/bmjopen-2024-088424.

  PMID: 39753264 DERIVED

• Aguirre Vergara F, Fischer A, Seuring T, de Beaufort C, Fagherazzi G, Aguayo GA. Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study. BMJ Open. 2023 Sep 13;13(9):e068264. doi: 10.1136/bmjopen-2022-068264.

  PMID: 37709324 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Guy A Fagherazzi, PhD

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: June 16, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)