DepressionNCT06070402
Use of a Voice Assistant to Improve Mental Health in Older People
A study of Depression and Loneliness, run by University of Valencia.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Loneliness, Anxiety
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Depression, Loneliness, Anxiety, Quality of Life
- Being tested
- DIAL, a voice-controlled virtual assistant
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAL, a voice-controlled virtual assistantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants randomly assigned to this group will test the DIAL device for four weeks Receives: Device: DIAL, a voice-controlled virtual assistant |
| Control group | No intervention | Participants randomly assigned to this group will not use the DIAL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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
Measured: Immediately after the intervention
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
Measured: Immediately after the intervention
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
Measured: Immediately after the intervention
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)
Measured: Immediately after the intervention
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
Measured: Immediately after the intervention
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)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València, Iniciativa Social Integral, Las Naves
- Responsible party
- Principal investigator, Rosa M. Baños Rivera, University of Valencia
- Investigators
- Rosa Mª Baños, Full professor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070402
- Sponsor's protocol ID
- 1828511
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06070402
- Acronym / sponsor ID
- 1828511
- Conditions
- Depression, Loneliness, Anxiety, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València, Iniciativa Social Integral, Las Naves
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: DIAL, a voice-controlled virtual assistantParticipants randomly assigned to this group will test the DIAL device for four weeks |
| Control group | No intervention | –Participants randomly assigned to this group will not use the DIAL device |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIAL, a voice-controlled virtual assistantParticipants 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. | Device | Experimental group |
Primary outcome
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
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
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
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
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
6 secondary outcomes
The System Usability Scale (SUS; Brooke, 1996; Sevilla González et al., 2020)
Time frame: Immediately after the intervention
The Client Satisfaction Questionnaire (CSQ; Roberts & Attkisson, 1983)
Time frame: Immediately after the intervention
Price they would be willing to pay
Time frame: Immediately after the intervention
Questions about skills
Time frame: Immediately after the intervention
Aspects related to the DIAL voice assistant
Time frame: Immediately after the intervention
Aspects related to DIAL's complementary care services (support person)
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Mª Baños, Full professor principal investigator
University of Valencia
Questions about this trial
What is this clinical trial studying?
A study of Depression and Loneliness, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamara Escrivá Martínez, Postdoctoral researcher (+34617923332, tamara.escriva@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.