Use of a Voice Assistant to Improve Mental Health in Older People

NCT06070402 | Unknown

• 1 other identifier: 1828511
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this study is to evaluate the effectiveness of DIAL (an innovative and user-friendly solution based on Multiplatform Voice Assistive Technologies) in reducing unwanted loneliness and increasing the mental health and the quality of life in individuals over 65 years old. Additionally, a secondary objective is to evaluate the experience of using the system, including aspects of usability and satisfaction, and to analyze whether the functionalities provided by DIAL contribute to the improvement of various dimensions in the lives of the elderly. It is hypothesized that DIAL will reduce unwanted loneliness and improve mental health in older people. In addition, we aim to obtain positive ratings in terms of usability and satisfaction with DIAL, along with the verification that most of the functionalities provided by DIAL will be useful to older people.

Conditions

Depression; Loneliness; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (5)

• UCLA Loneliness Scale (UCLA; Russell et al., 1980; Vázquez & Jiménez, 1994)

  The instrument measures the feeling of loneliness and consists of 20 items, 11 of which are negative (for example, I lack company) and nine positive (for example, I feel in tune with the people around me). All items are scored from 1 (never) to 4 (frequently). After reversing the score on items 1, 5, 6, 9, 10, 15, 16, 19 and 20, the scores corresponding to the 20 items are added, obtaining a total isolation score. The range of scores goes from 20 to 80, with a higher score corresponding to a greater degree of loneliness

  Pre-intervention, immediately after the intervention, and follow-up (3 months)

• Health-related quality of life scale (EuroQol-5D; Herdman et al., 2001).

  This scale measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each category consists of 1 item, ranging from 1 (no problems) to 3 (many problems). The second part of the EQ-5D-3L is a 20-centimeter vertical visual analog scale, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The individual must mark the point on the scale that best reflects the assessment of their current global health status. The use of the VAS provides a complementary score to the descriptive system of self-assessment of the individual's health status

  Pre-intervention, immediately after the intervention, and follow-up (3 months)

• The World Health Organization Quality of Life-Old (WHOQOL-OLD Scale; Power et al., 2005; Lucas-Carrasco et al., 2011).

  The WHOQOL-OLD is a 24-item self-report instrument that is divided into six facets: Facet 1- Sensory abilities (items 1, 2, 10, 20); Facet 2- Autonomy (items 3, 4, 5, 11); Facet 3- Past, present and future activities (items 12, 13, 15, 19); Facet 4- Social participation (items 14, 16, 17, 18); Facet 5- Death (items 6, 7, 8, 9); and Facet 6- Intimacy (items 21, 22, 23, 24). Responses are based on a 5-point Likert-type response scale (ranging from 1-5), with items 1, 2, 6, 7, 8, 9, and 10 reverse scored. WHOQOL-OLD total scores in each facet range from 4 to 20, with higher scores indicating better quality of life. A global score (general QOL - GQOL) is also calculated from the set of 24 items

  Pre-intervention, immediately after the intervention, and follow-up (3 months)

• The Generalized Anxiety Disorder Questionnaire-2 (GAD-2; Kroenke et al., 2007; García-Campayo et al., 2012)

  It is a self-report measure containing 2 items assessing anxiety symptoms. The items are scored on a 4-point Likert scale, ranging from 0 (no days) to 3 (almost every day), where a high score indicates greater anxiety symptoms

  Pre-intervention, immediately after the intervention, and follow-up (3 months)

• The Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003; Rodríguez-Muñoz et al., 2017)

  It is a self-report measure consisting of 2 items assessing depressive symptoms. The items are scored on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day), where a high score indicates higher levels of depressive symptoms

  Pre-intervention, immediately after the intervention, and follow-up (3 months)

Secondary Outcomes (6)

• The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)

  Immediately after the intervention

• The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)

  Immediately after the intervention

• Price they would be willing to pay

  Immediately after the intervention

• Questions about skills

  Immediately after the intervention

• Aspects related to the DIAL voice assistant

  Immediately after the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants randomly assigned to this group will test the DIAL device for four weeks

Device: DIAL, a voice-controlled virtual assistant

Control group

NO INTERVENTION

Participants randomly assigned to this group will not use the DIAL device

Interventions

DIAL, a voice-controlled virtual assistant DEVICE

Participants in the experimental group will test in their homes a device called DIAL, a voice-controlled virtual assistant designed to communicate with the elderly and help them in different contexts. They will use it for four weeks. They will receive an individual training session on how to use the device, an instruction sheet for its use and, in addition, they will receive telephone technical support throughout the study. Finally, the device will be uninstalled and all participants will be called back to answer the same survey they answered before the intervention.

Experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \) Be 65 years old or older, 2) Speak Spanish, 3) Meet at least one criterion of vulnerability to suffering unwanted loneliness (the criteria will be taken from the European report by Baarck et al. 2021. For example, being a widower, have a physical illness...), 4) Ability and willingness to participate in the study.

You may not qualify if:

• \) Present cognitive impairment, 2) Suffer from a serious mental problem (e.g. depression, schizophrenia) or 3) Suffer from a serious physical problem (e.g. blindness or deafness) that makes interaction with the device difficult.

Sponsors & Collaborators

• University of Valencia: lead
• Universitat Politècnica de València: collaborator
• Iniciativa Social Integral: collaborator
• Las Naves: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Rosa Mª Baños, Full professor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Escrivá Martínez, Postdoctoral researcher

CONTACT

+34617923332; tamara.escriva@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental design with two groups: the control group and the experimental group, using pre and post evaluations by means of a randomized controlled trial.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: October 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL