Clinical trial NCT06070402: Use of a Voice Assistant to Improve Mental Health in Older People
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Loneliness
Anxiety
Quality of Life
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
name: Iniciativa Social Integral
name: Las Naves
First posted: 2023-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental design with two groups: the control group and the experimental group, using pre and post evaluations by means of a randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: UCLA Loneliness Scale (UCLA; Russell et al., 1980; Vázquez & Jiménez, 1994)
timeFrame: Pre-intervention, immediately after the intervention, and follow-up (3 months)
measure: Health-related quality of life scale (EuroQol-5D; Herdman et al., 2001).
timeFrame: Pre-intervention, immediately after the intervention, and follow-up (3 months)
measure: The World Health Organization Quality of Life-Old (WHOQOL-OLD Scale; Power et al., 2005; Lucas-Carrasco et al., 2011).
timeFrame: Pre-intervention, immediately after the intervention, and follow-up (3 months)
measure: The Generalized Anxiety Disorder Questionnaire-2 (GAD-2; Kroenke et al., 2007; García-Campayo et al., 2012)
timeFrame: Pre-intervention, immediately after the intervention, and follow-up (3 months)
measure: The Patient Health Questionnaire-2 (PHQ-2; Kroenke et al., 2003; Rodríguez-Muñoz et al., 2017)
timeFrame: Pre-intervention, immediately after the intervention, and follow-up (3 months)
Secondary outcomes:
measure: The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)
timeFrame: Immediately after the intervention
measure: The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)
timeFrame: Immediately after the intervention
measure: Price they would be willing to pay
timeFrame: Immediately after the intervention
measure: Questions about skills
timeFrame: Immediately after the intervention
measure: Aspects related to the DIAL voice assistant
timeFrame: Immediately after the intervention
measure: Aspects related to DIAL's complementary care services (support person)
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Rosa Mª Baños, Full professor
role: PRINCIPAL_INVESTIGATOR
References: