Social Isolation in Older AdultsVirtualDONANCT06956794
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
A study testing VirtualDONA Multimodal Program in people with Social Isolation in Older Adults and Poverty, run by Consorci Sanitari de Terrassa at 2 sites in Spain.
Trial summary
This study aims to evaluate the effectiveness of an immersive virtual reality-based multimodal intervention (VirtualDONA) to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Social Isolation in Older Adults, Poverty
- What is being tested?
- VirtualDONA Multimodal Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 5 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female
- Age 65 years or older
- Living alone
- Registered with the elderly care services of Suara Cooperativa
- Annual income below the guaranteed minimum income threshold (below €20,353.62/year)
- Global cognitive functioning not suggestive of dementia, defined as MMSE score ≥ 24
Show all 9Show fewer
- Able to read and write
- Good command of Catalan and/or Spanish
- Signed informed consent to participate in the study
Who cannot join
- History of severe neurological, psychiatric disorders, or intellectual disability
- Uncorrected sensory deficits (e.g., vision or hearing)
- Physical or motor impairments that may interfere with participation or bias outcome measures
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
SUARA Cooperativa
Barcelona, Barcelona, 08018
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
About this study
Official title: Multimodal Training With Immersive VIRTUAL Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone (VirtualDONA)
This study aims to evaluate the effectiveness of an immersive virtual reality-based multimodal intervention (VirtualDONA) to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. The intervention combines mindfulness, cognitive, and physical training in a group format over 8 weeks.
Read the detailed description
The VirtualDONA project aims to promote the health of older women living alone and at risk of poverty, as they are considered a highly vulnerable population. Women's longer life expectancy compared to men leads to a greater proportion of women living alone. In Catalonia, there are 786,000 people living alone, and 42.2% are aged 65 or older. The combination of being a woman, of advanced age, and living alone is associated with a high rate of poverty.
These social and economic determinants significantly increase the likelihood of developing dementia and/or mental health disorders in affected individuals. Research has established a connection between social isolation, aging, and a higher probability of experiencing dementia, stress, depression, and anxiety. Economic uncertainty is also known to contribute to stress and anxiety, while social stigma-particularly affecting older women-can negatively impact their cognitive and mental health.
All of these factors highlight the need for preventive interventions targeting women over the age of 65 who live alone and have incomes below the minimum income threshold. VirtualDONA proposes a preventive intervention for this population using immersive virtual reality technology (without headsets) to improve cognitive functioning, emotional well-being, and quality of life.
The intervention will be delivered in a group format over 8 weeks (16 sessions). The combination of mindfulness, cognitive, and physical exercises within a virtual environment offers a suitable multimodal platform for a comprehensive and innovative intervention aimed at vulnerable women. The project aims to demonstrate the benefits of this approach and to develop a sustainable, scalable, and long-term viable business model.
- Conditions
- Social Isolation in Older Adults, Poverty
- Being tested
- VirtualDONA Multimodal Program
- Keywords
- Social Isolation, Cognitive Dysfunction, Aging, Poverty, Virtual Immersive Reality
- Medical subject headings
- Social Isolation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VirtualDONA Multimodal ProgramBehavioural
A group-based behavioral intervention using immersive virtual reality without headsets. The 8-week program includes 16 sessions combining mindfulness, cognitive training, and physical exercises, designed to improve cognitive health and emotional well-being in older women living alone and at risk of poverty.
| Study group | Role | What they receive |
|---|---|---|
| Immersive VR-Based Multimodal Intervention | Experimental | Participants in this arm will receive a multimodal, group-based intervention using immersive virtual reality without headsets. The intervention includes mindfulness, cognitive training, and physical exercises delivered in 16 group sessions over 8 weeks. Receives: Behavioral: VirtualDONA Multimodal Program |
| Usual Activity (Control Group) | No intervention | Participants in this arm will continue their usual daily routines with no specific intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in scores of global cognition
Global cognition is assessed with the Mini-Mental State Examination (MMSE), a brief screening tool for cognitive impairment. The MMSE includes items that evaluate orientation, registration, attention and calculation, recall, language, and visuospatial ability. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of global cognition
Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of verbal episodic memory
Verbal episodic memory is assessed with the Free and Cued Selective Reminding Test (FCSRT), which evaluates the ability to learn and recall words with both free and cued recall conditions. The total score ranges from 0 to 48, based on the number of words correctly recalled. Higher scores indicate better memory performance.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of auditory attention
Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of working memory
Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of processing speed
Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of visual scanning and processing speed
Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of executive functioning and cognitive flexibility
Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of executive functioning
Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors indicate worse performance, while more categories completed reflect better executive functioning.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of selective attention, inhibition, and processing speed
Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of phonetic fluency
Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of semantic verbal fluency
Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.
Measured: Baseline and after the 8-week intervention
Differences between groups in language
Language function is assessed using the 15-item version of the Boston Naming Test (BNT), a confrontation naming task consisting of 15 black-and-white line drawings of objects with increasing difficulty. The total score is the number of correctly named items. Higher scores indicate better naming ability.
Measured: Baseline and after the 8-week intervention
Secondary outcomes (10)
Differences between groups in scores of Quality of Life
Quality of Life is measured with EuroQoL-5D (EQ-5D) a self-completion questionnaire, which consists of five questions: covering mobility, hygiene, activities, pain, and anxiety. The descriptive system divides each of the 5 dimensions into three levels of response: the absence of a problem, some problem, and extreme problem. Lower scores indicate better outcomes. In addition, the questionnaire has a plus scale where the participants rated their health state on a scale of 0-100. In this scale, higher scores indicate better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of loneliness
Loneliness levels are measured through the UCLA Loneliness Scale, a widely recognized tool for measuring subjective feelings of loneliness or social isolation. The most recent version, contains 20 items rated on a scale from 1 (Never) to 4 (Always). Higher scores indicate worse outcomes.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of perceived social support
Perceived social support is measured with the Oslo 3-Item Social Support Scale (OSLO-3). The OSLO-3 is a brief measure of perceived social support, consisting of three items assessing the number of close confidants, perceived concern from others, and ease of obtaining practical help. Scores range from 3 to 14, with higher scores indicating greater perceived social support.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of emotional well-being
Emotional well-being is measured with the WHO-Five Wellbeing Index Scale (WHO-5). The WHO-5 is a brief self-reported measure of current mental well-being, consisting of five positively worded items. Each item is rated on a 6-point Likert scale, resulting in a raw score ranging from 0 to 25. The score is multiplied by 4 to yield a final score ranging from 0 to 100, where higher scores indicate better well-being.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of depression
Depression is measured with the Patient Health Questionnaire-9 (PHQ-9) which scores each of the 9 DSM-IV criteria as "not at all" (0 points) to "nearly every day" (3 points). Higher scores mean a worse outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of anxiety
Anxiety is measured with the 7-item Generalized Anxiety Disorder Scale (GAD-7), a Likert-type scale with questions ranging from "not at all" (0 points) to "nearly every day" (3 points). The maximum score is 24. Higher scores mean a worse outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of frailty
Frailty is measured with the FRAIL scale. The FRAIL Scale is a 5-item screening tool that assesses frailty based on fatigue, resistance, ambulation, illnesses, and loss of weight. Each item is scored as 0 (no) or 1 (yes), with total scores ranging from 0 to 5. Higher scores indicate greater levels of frailty.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of dietary habits
Dietary haabits are measured with the PREDIMED questionnaire (adherence to the Mediterranean diet). The PREDIMED is a 14-item questionnaire used to assess adherence to the Mediterranean diet. Each item is scored 0 or 1 depending on dietary habits, resulting in a total score ranging from 0 to 14. Higher scores indicate greater adherence to the Mediterranean diet.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of performed physical activity
Performed physical activity is measured with The International Physical Activity Questionnaire (IPAQ) is a questionnaire composed of 7 questionsin order to assessthe frequency, duration, and intensity (vigorous or moderate) of the performed physical activity, walking, and sitting time during a business day for the last 7 days. Later, from the minutes obtained from the participant's answers, the METS (metabolic equivalent tasks) conversion is performed, allowing a classification, depending on the energy consumption obtained for each activity, into three categories (low, medium, high). Higher score indicate better outcome.
Measured: Baseline and after the 8-week intervention
Differences between groups in scores of Sleep Quality
Sleep Quality is measured with The Pittsburgh Sleep Quality Index (PSQI). This test presents 24 items, although only 19 are taken into account for the correction. This test is divided into 7 dimensions, namely, sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, hypnotic drugs, and daytime dysfunction. Higher scores indicate worse sleep quality.
Measured: Baseline and after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start5 May 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Isolation in Older AdultsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two parallel groups: one receiving a multimodal group-based intervention using immersive virtual reality, and a control group maintaining usual activities. The intervention consists of 16 sessions over 8 weeks.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Broomx Technologies, Suara Serveis SCCL
- Responsible party
- Principal investigator, Maite Garolera, Consorci Sanitari de Terrassa
- Investigators
- Maite Garolera, PhD, Principal investigator, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956794
- Sponsor's protocol ID
- 2024PROD00053
- Acronym
- VirtualDONA
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Training With Immersive VIRTUAL Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone (VirtualDONA)
- ClinicalTrials.gov ID
- NCT06956794
- Acronym / sponsor ID
- VirtualDONA / 2024PROD00053
- Conditions
- Social Isolation in Older Adults, Poverty
- Keywords
- Social Isolation, Cognitive Dysfunction, Aging, Poverty, Virtual Immersive Reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Broomx Technologies, Suara Serveis SCCL
- Study start
- 5 May 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2025 (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.
This study aims to evaluate the effectiveness of an immersive virtual reality-based multimodal intervention (VirtualDONA) to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. The intervention combines mindfulness, cognitive, and physical training in a group format over 8 weeks.
Detailed description
The VirtualDONA project aims to promote the health of older women living alone and at risk of poverty, as they are considered a highly vulnerable population. Women's longer life expectancy compared to men leads to a greater proportion of women living alone. In Catalonia, there are 786,000 people living alone, and 42.2% are aged 65 or older. The combination of being a woman, of advanced age, and living alone is associated with a high rate of poverty.
These social and economic determinants significantly increase the likelihood of developing dementia and/or mental health disorders in affected individuals. Research has established a connection between social isolation, aging, and a higher probability of experiencing dementia, stress, depression, and anxiety. Economic uncertainty is also known to contribute to stress and anxiety, while social stigma-particularly affecting older women-can negatively impact their cognitive and mental health.
All of these factors highlight the need for preventive interventions targeting women over the age of 65 who live alone and have incomes below the minimum income threshold. VirtualDONA proposes a preventive intervention for this population using immersive virtual reality technology (without headsets) to improve cognitive functioning, emotional well-being, and quality of life.
The intervention will be delivered in a group format over 8 weeks (16 sessions). The combination of mindfulness, cognitive, and physical exercises within a virtual environment offers a suitable multimodal platform for a comprehensive and innovative intervention aimed at vulnerable women. The project aims to demonstrate the benefits of this approach and to develop a sustainable, scalable, and long-term viable business model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel groups: one receiving a multimodal group-based intervention using immersive virtual reality, and a control group maintaining usual activities. The intervention consists of 16 sessions over 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Immersive VR-Based Multimodal Intervention | Experimental | Behavioral: VirtualDONA Multimodal ProgramParticipants in this arm will receive a multimodal, group-based intervention using immersive virtual reality without headsets. The intervention includes mindfulness, cognitive training, and physical exercises delivered in 16 group sessions over 8 weeks. |
| Usual Activity (Control Group) | No intervention | –Participants in this arm will continue their usual daily routines with no specific intervention during the study period. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Female
- Age 65 years or older
- Living alone
- Registered with the elderly care services of Suara Cooperativa
- Annual income below the guaranteed minimum income threshold (below €20,353.62/year)
Key exclusion criteria (3 listed)
- History of severe neurological, psychiatric disorders, or intellectual disability
- Uncorrected sensory deficits (e.g., vision or hearing)
- Physical or motor impairments that may interfere with participation or bias outcome measures
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 |
|---|---|---|
| VirtualDONA Multimodal ProgramA group-based behavioral intervention using immersive virtual reality without headsets. The 8-week program includes 16 sessions combining mindfulness, cognitive training, and physical exercises, designed to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. | Behavioural | Immersive VR-Based Multimodal Intervention |
Primary outcome
Differences between groups in scores of global cognition
Time frame: Baseline and after the 8-week intervention
Global cognition is assessed with the Mini-Mental State Examination (MMSE), a brief screening tool for cognitive impairment. The MMSE includes items that evaluate orientation, registration, attention and calculation, recall, language, and visuospatial ability. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Differences between groups in scores of global cognition
Time frame: Baseline and after the 8-week intervention
Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
Differences between groups in scores of verbal episodic memory
Time frame: Baseline and after the 8-week intervention
Verbal episodic memory is assessed with the Free and Cued Selective Reminding Test (FCSRT), which evaluates the ability to learn and recall words with both free and cued recall conditions. The total score ranges from 0 to 48, based on the number of words correctly recalled. Higher scores indicate better memory performance.
Differences between groups in scores of auditory attention
Time frame: Baseline and after the 8-week intervention
Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of working memory
Time frame: Baseline and after the 8-week intervention
Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.
Differences between groups in scores of processing speed
Time frame: Baseline and after the 8-week intervention
Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.
Differences between groups in scores of visual scanning and processing speed
Time frame: Baseline and after the 8-week intervention
Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.
Differences between groups in scores of executive functioning and cognitive flexibility
Time frame: Baseline and after the 8-week intervention
Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.
Differences between groups in scores of executive functioning
Time frame: Baseline and after the 8-week intervention
Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors indicate worse performance, while more categories completed reflect better executive functioning.
Differences between groups in scores of selective attention, inhibition, and processing speed
Time frame: Baseline and after the 8-week intervention
Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
Differences between groups in scores of phonetic fluency
Time frame: Baseline and after the 8-week intervention
Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.
Differences between groups in scores of semantic verbal fluency
Time frame: Baseline and after the 8-week intervention
Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.
Differences between groups in language
Time frame: Baseline and after the 8-week intervention
Language function is assessed using the 15-item version of the Boston Naming Test (BNT), a confrontation naming task consisting of 15 black-and-white line drawings of objects with increasing difficulty. The total score is the number of correctly named items. Higher scores indicate better naming ability.
10 secondary outcomes
Differences between groups in scores of Quality of Life
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of loneliness
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of perceived social support
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of emotional well-being
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of depression
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of anxiety
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of frailty
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of dietary habits
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of performed physical activity
Time frame: Baseline and after the 8-week intervention
Differences between groups in scores of Sleep Quality
Time frame: Baseline and after the 8-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Maite Garolera, PhD principal investigator
Consorci Sanitari de Terrassa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VirtualDONA Multimodal Program in people with Social Isolation in Older Adults and Poverty, run by Consorci Sanitari de Terrassa at 2 sites in Spain.
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 9 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups in scores of global cognition (time frame: Baseline and after the 8-week intervention). The study lists 13 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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.