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

Not Applicable
Not yet recruiting
Conditions
Depression
Anxiety
Quality of Life
Loneliness
Interventions
Device: DIAL, a voice-controlled virtual assistant
Registration Number
NCT06070402
Lead Sponsor
University of Valencia
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.

Detailed 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 & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupDIAL, a voice-controlled virtual assistantParticipants randomly assigned to this group will test the DIAL device for four weeks
Primary Outcome Measures
NameTimeMethod
UCLA Loneliness Scale (UCLA; Russell et al., 1980; Vázquez & Jiménez, 1994)Pre-intervention, immediately after the intervention, and follow-up (3 months)

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

The Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003; Rodríguez-Muñoz et al., 2017)Pre-intervention, immediately after the intervention, and follow-up (3 months)

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

Health-related quality of life scale (EuroQol-5D; Herdman et al., 2001).Pre-intervention, immediately after the intervention, and follow-up (3 months)

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

The World Health Organization Quality of Life-Old (WHOQOL-OLD Scale; Power et al., 2005; Lucas-Carrasco et al., 2011).Pre-intervention, immediately after the intervention, and follow-up (3 months)

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

The Generalized Anxiety Disorder Questionnaire-2 (GAD-2; Kroenke et al., 2007; García-Campayo et al., 2012)Pre-intervention, immediately after the intervention, and follow-up (3 months)

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

Secondary Outcome Measures
NameTimeMethod
The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)Immediately after the intervention

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

Price they would be willing to payImmediately after the intervention

We will ask them what price they would be willing to pay for DIAL, between 0 and 100 euros per month

The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)Immediately after the intervention

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

Questions about skillsImmediately after the intervention

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)

Aspects related to DIAL's complementary care services (support person)Immediately after the intervention

They will be asked what aspects have improved in their life since they have had the complementary services of DIAL (the support person)

Aspects related to the DIAL voice assistantImmediately after the intervention

They will be asked what aspects have improved in their life since the application has been installed in their home

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