- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070402
Use of a Voice Assistant to Improve Mental Health in Older People
September 29, 2023 updated by: Rosa M. Baños Rivera, University of Valencia
Use of a Voice Assistant (DIAL) to Improve Unwanted Loneliness, Mental Health, and Quality of Life in Older People: a Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tamara Escrivá Martínez, Postdoctoral researcher
- Phone Number: +34617923332
- Email: tamara.escriva@uv.es
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Participants randomly assigned to this group will test the DIAL device for four weeks
|
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.
|
No Intervention: Control group
Participants randomly assigned to this group will not use the DIAL device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UCLA Loneliness Scale (UCLA; Russell et al., 1980; Vázquez & Jiménez, 1994)
Time Frame: 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
|
Pre-intervention, immediately after the intervention, and follow-up (3 months)
|
Health-related quality of life scale (EuroQol-5D; Herdman et al., 2001).
Time Frame: 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
|
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).
Time Frame: 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
|
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)
Time Frame: 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
|
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)
Time Frame: 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
|
Pre-intervention, immediately after the intervention, and follow-up (3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)
Time Frame: 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
|
Immediately after the intervention
|
The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)
Time Frame: 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
|
Immediately after the intervention
|
Price they would be willing to pay
Time Frame: Immediately after the intervention
|
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
|
Questions about skills
Time Frame: Immediately 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)
|
Immediately after the intervention
|
Aspects related to the DIAL voice assistant
Time Frame: Immediately after the intervention
|
They will be asked what aspects have improved in their life since the application has been installed in their home
|
Immediately after the intervention
|
Aspects related to DIAL's complementary care services (support person)
Time Frame: 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)
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rosa Mª Baños, Full professor, University of Valencia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 15, 2023
Primary Completion (Estimated)
November 15, 2023
Study Completion (Estimated)
November 15, 2023
Study Registration Dates
First Submitted
September 29, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1828511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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