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

Depression Clinical Trial

Official title:

Use of a Voice Assistant (DIAL) to Improve Unwanted Loneliness, Mental Health, and Quality of Life in Older People: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06070402
• Other study ID #: 1828511
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: September 2023
• Source: University of Valencia
• Contact: Tamara Escrivá Martínez, Postdoctoral researcher
• Phone: +34617923332
• Email: tamara.escriva[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The main objective of this study is to evaluate the effectiveness of DIAL in reducing unwanted loneliness and increasing the mental health and the quality of life of elderly people. 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. For this purposes, a randomized controlled trial with a control group and an experimental group will be conducted in Valencia at the end of 2023. Participants in the experimental group will use DIAL for four weeks. All participants will complete different measures of mental health and quality of life, as well as measures related to the experience of using DIAL. Mixed ANOVA tests will be used to determine if there were statistically significant differences between the different measures evaluated. An alpha of 0.05 will be taken as the confidence level. In addition, a descriptive study will be conducted on the variables related to the DIAL user experience. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 1) 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.

Exclusion Criteria:

• 1) 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Loneliness
• Quality of Life

Intervention

Device:
• DIAL, a voice-controlled virtual assistant
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Valencia	Iniciativa Social Integral, Las Naves, Universitat Politècnica de València

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)	It is a self-reported measure that assesses the overall usability of the tool. It is a 10-item scale, measured on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total SUS scores range from 0 to 100.The questionnaire is designed to be answered after the user's interaction with the system	Immediately after the intervention
Secondary	The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)	It is a self-report questionnaire that assesses the patient's overall satisfaction with the tool. It consists of 8 items on a 4-point Likert scale ranging from 1 (lowest score per item) to 4 (highest score per item). The total score ranges from 8 to 32, with higher values indicating higher satisfaction	Immediately after the intervention
Secondary	Price they would be willing to pay	We will ask them what price they would be willing to pay for DIAL, between 0 and 100 euros per month	Immediately after the intervention
Secondary	Questions about skills	Older people will be asked if DIAL has helped them in different facets of their lives. Specifically, if it has helped them to: improve their mood, feel more understood, feel listened to, feel supported, feel more supported, feel more accompanied, drink more water, have better hygiene, walk more, take their medication better, move more, talk more with people close to them, be more in contact with people close to them (family or friends)	Immediately after the intervention
Secondary	Aspects related to the DIAL voice assistant	They will be asked what aspects have improved in their life since the application has been installed in their home	Immediately after the intervention
Secondary	Aspects related to DIAL's complementary care services (support person)	They will be asked what aspects have improved in their life since they have had the complementary services of DIAL (the support person)	Immediately after the intervention