LonelinessANS-SENCT04242628
The Ageing in a Networked Society -Social Experiment Study
A study testing Facebook course and Lifestyle Course in people with Loneliness and Social Isolation, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
The Ageing in a Networked Society -Social Experiment study (ANS-SE) is a randomised controlled trial on older people residing in Abbiategrasso, a middle-size city located in the Milan area (Italy) and aims to assess the impact of SNS use on loneliness, that is the primary outcome of this study. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Loneliness, Social Isolation
- What is being tested?
- Facebook course and Lifestyle Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2019to 30 Sep 2020
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants to the third follow-up of the Brain Ageing in Abbiategrasso Study (InveCe.Ab study)
- Good mental health
- No physical limitations
- Good cognitive health
- No experience in using Social Networks SItes (SNSs)
Who cannot join
- GDS (Geriatric Depression Score) score equal to or greater than 10 (no major depression)
- Hands functional limitations
- Visual or hearing impairment
- Dementia or Mild Cognitive Impairment (MCI),
- Mini-Mental State Examination (MMSE) lower than 24
- Used SNS at least one time in life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing
The Ageing in a Networked Society -Social Experiment study (ANS-SE) is a randomised controlled trial on older people residing in Abbiategrasso, a middle-size city located in the Milan area (Italy) and aims to assess the impact of SNS use on loneliness, that is the primary outcome of this study. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.
Read the detailed description
The objective of the study is to evaluate the short-term and long-term impact of Facebook use on physical and mental health of older people. The experiment is carried out on 180 participants of the Brain Aging in Abbiategrasso Study (InveCe).The InveCE study is a biannual cohort study of older people born between 1935 and 1939 and living in Abbiategrasso, a town near Milan, in northern Italy (NCT01345110, ClinicalTrials.gov). For more information, see http://www.golgicenci.it/en/studio-invece/.
Participants are selected among those who agreed to take part in the 4th wave of the InveCe.Ab study. Inclusion and exclusion criteria are specified in the Eligibility box below. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. Participant are assigned to one of these three groups randomly. Before/after the intervention, researchers administered a questionaire to participants to measure levels of loneliness, depression and neuropsychological functioning (see the box "Outcome Measure" for the description of the scales and measures used), together with a medical examination. The same assessment will be performed after one year. Data collected will be analyzed using statistical techniques in order to evaluate the impact of Facebook use on well-being.
The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.
- Conditions
- Loneliness, Social Isolation
- Being tested
- Facebook course, Lifestyle Course
- Keywords
- UCLA Version 3 scale, LSNS-6 scale
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facebook courseOther
The intervention consists of the attendance to a course on Facebook and Social Networking Sites use
Lifestyle CourseOther
The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people
| Study group | Role | What they receive |
|---|---|---|
| Facebook course | Experimental | T1 study members attended a three week course (two classes per week) on smartphones and SNS use. Specifically, the course covers the following topics: smartphone use; Facebook use; WhatsApp use, privacy rules and fraud risk prevention using Facebook. Throughout the duration of the intervention, a tutor was available every Tuesday and Thursday to assist T1 participants in using SNSs. Receives: Other: Facebook course |
| Lifestyle course | Experimental | T2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. These meetings covered the following topics regarding good habits for wellbeing at older age: nutrition, brain ageing, physical activity, leisure activities, resources of the city for older people. A goodbye tea was offered after the meetings. Receives: Other: Lifestyle Course |
| Waiting list | No intervention | Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective feeling of loneliness
Indicates self feeling of loneliness. Measured with UCLA Loneliness Scale Minimum score: 20; Maximum score: 80 Highest scores indicate greater loneliness (Russell, 1996).
Measured: Change from basline score at UCLA Loneliness Scale at 2 months
Stroop Test (inhibitory control and cognitive flexibility)
Executive Cognitive Functions measured through the Stroop Test Interference score for time and errors (higher scores worse performance) Score range: n.a. (Cafarra et al., 2002)
Measured: Change from basline score at test at 2 months
Executive Cognitive functions: processing speed in Symbol Search
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).
Symbol Search, score range 0-60 Higher scores better performances (Orsini \& Pezzuti, 2013)
Measured: Change from basline score at test at 2 months
Executive Cognitive functions: processing speed in Coding
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).
Coding: score range 0-135 Higher scores better performances (Orsini \& Pezzuti, 2013)
Measured: Change from basline score at test at 2 months
Executive Cognitive functions: working memory
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV).
Digit Span: score range 0-48 Higher scores better performances (Orsini \& Pezzuti, 2013)
Measured: Change from basline score at test at 2 months
Executive Cognitive Functions - Trail Making Test (TMT)
Executive Cognitive Functions measured through the Trail Making Test (TMT) (Giovagnoli et al., 1996)
Measured: Change from basline score at test at 2 months
Cumulative Illness Rating Scale
Clinical tool to measure objective older people illness status Scores range between 14 to 70 with a higher score indicating worse health satus (Parmelee et al. 1995)
Measured: Change from basline score at scale at 2 months
Blood Pressure
High blood pressure, measured in mmHg,can be an indicator of stress or other health problems
Measured: Change from basline score for blood pressure at 2 months
6 items Lubben Social Network Scale
This scale is a self-report measure of social engagement including family and friends. The score ranges between 0 and 30, with a higher score indicating more social engagement. (Lubben et al. 2006).
Measured: Change from basline score at Lubben Social Network scale at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start14 Jan 2019
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consists of the attendance to two training courses. T1 study members attended a three week course (two classes per week) on smartphones and SNS use. T2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. A goodbye tea was offered after T2 meetings. Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019). One year after the first intervention, i.e. in March 2020, we will carry out a follow up assessment on T1 and T2 participants. Note that, due to the constraints imposed by the ethical committee (i.e. we offered members of the C group the possibility to attend the SNS course during the first intervention), the members of the C group are excluded from the follow up.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Golgi Cenci
- Responsible party
- Sponsor
- Investigators
- Emanuela Sala, PhD, Principal investigator, Università degli Studi di Milano-Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242628
- Sponsor's protocol ID
- 2017-0946
- Acronym
- ANS-SE
- Status last verified
- Apr 2021
- First submitted
- 16 Dec 2019
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request by email to Fondazione Golgi Cenci. Applicants will receive a form to fill with all the information about the research design and purpose. The application will be evaluated by a comittee chaired by Prof. Emanuela Sala. The final decision will be communicated within two weeks.
Publications
Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
PubMed 8576833Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.
PubMed 8915764Caffarra P., Vezzadini G., Dieci F., Zonato A., Venneri A., Una versione abbreviata del test di stroop: dati normativi nella popolazione italiana. Nuova Rivista di Neurologia 2002, 12 (14): 111-115.
Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995 Feb;43(2):130-7. doi: 10.1111/j.1532-5415.1995.tb06377.x.
PubMed 7836636Orsini A., Pezzuti L.(2013). WAIS-IV. Contributo alla taratura italiana.Giunti OS. Firenze.
Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.
PubMed 16921004Rolandi E, Vaccaro R, Abbondanza S, Casanova G, Pettinato L, Colombo M, Guaita A. Loneliness and Social Engagement in Older Adults Based in Lombardy during the COVID-19 Lockdown: The Long-Term Effects of a Course on Social Networking Sites Use. Int J Environ Res Public Health. 2020 Oct 28;17(21):7912. doi: 10.3390/ijerph17217912.
PubMed 33126634
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Experiment on the Impact of Social Networking Sites (SNSs) Use on Older People's Wellbeing
- ClinicalTrials.gov ID
- NCT04242628
- Acronym / sponsor ID
- ANS-SE / 2017-0946
- Conditions
- Loneliness, Social Isolation
- Keywords
- UCLA Version 3 scale, LSNS-6 scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Fondazione Golgi Cenci
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Jan 2020 (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 Ageing in a Networked Society -Social Experiment study (ANS-SE) is a randomised controlled trial on older people residing in Abbiategrasso, a middle-size city located in the Milan area (Italy) and aims to assess the impact of SNS use on loneliness, that is the primary outcome of this study. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.
Detailed description
The objective of the study is to evaluate the short-term and long-term impact of Facebook use on physical and mental health of older people. The experiment is carried out on 180 participants of the Brain Aging in Abbiategrasso Study (InveCe).The InveCE study is a biannual cohort study of older people born between 1935 and 1939 and living in Abbiategrasso, a town near Milan, in northern Italy (NCT01345110, ClinicalTrials.gov). For more information, see http://www.golgicenci.it/en/studio-invece/.
Participants are selected among those who agreed to take part in the 4th wave of the InveCe.Ab study. Inclusion and exclusion criteria are specified in the Eligibility box below. The study is constituted of two stages, i.e. the baseline and the follow up. The experiment is structured into two treatment groups and a control group; the interventions are the attendance to a course on SNS use (T1) and lifestyle education and brain functioning (T2). The control group (C) is constituted of a waiting list. Participant are assigned to one of these three groups randomly. Before/after the intervention, researchers administered a questionaire to participants to measure levels of loneliness, depression and neuropsychological functioning (see the box "Outcome Measure" for the description of the scales and measures used), together with a medical examination. The same assessment will be performed after one year. Data collected will be analyzed using statistical techniques in order to evaluate the impact of Facebook use on well-being.
The study is part of the project "Aging in a networked society. Older people, social networks and well-being", funded by the Italian Fondazione Cariplo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The intervention consists of the attendance to two training courses. T1 study members attended a three week course (two classes per week) on smartphones and SNS use. T2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. A goodbye tea was offered after T2 meetings. Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019). One year after the first intervention, i.e. in March 2020, we will carry out a follow up assessment on T1 and T2 participants. Note that, due to the constraints imposed by the ethical committee (i.e. we offered members of the C group the possibility to attend the SNS course during the first intervention), the members of the C group are excluded from the follow up.
| Arm | Type | Receives |
|---|---|---|
| Facebook course | Experimental | Other: Facebook courseT1 study members attended a three week course (two classes per week) on smartphones and SNS use. Specifically, the course covers the following topics: smartphone use; Facebook use; WhatsApp use, privacy rules and fraud risk prevention using Facebook. Throughout the duration of the intervention, a tutor was available every Tuesday and Thursday to assist T1 participants in using SNSs. |
| Lifestyle course | Experimental | Other: Lifestyle CourseT2 study members attended 5 interactive 90-min meetings on lifestyle education and brain functioning in older people. These meetings covered the following topics regarding good habits for wellbeing at older age: nutrition, brain ageing, physical activity, leisure activities, resources of the city for older people. A goodbye tea was offered after the meetings. |
| Waiting list | No intervention | –Throughout the duration of the intervention, we put C study members on a waiting list; at the end of the intervention, in June 2019, interested group C study members attended the SNSs course (held on June 2019). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Participants to the third follow-up of the Brain Ageing in Abbiategrasso Study (InveCe.Ab study)
- Good mental health
- No physical limitations
- Good cognitive health
- No experience in using Social Networks SItes (SNSs)
Key exclusion criteria (6 listed)
- GDS (Geriatric Depression Score) score equal to or greater than 10 (no major depression)
- Hands functional limitations
- Visual or hearing impairment
- Dementia or Mild Cognitive Impairment (MCI),
- Mini-Mental State Examination (MMSE) lower than 24
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 |
|---|---|---|
| Facebook courseThe intervention consists of the attendance to a course on Facebook and Social Networking Sites use | Other | Facebook course |
| Lifestyle CourseThe intervention consists of the attendance to a course on lifestyle education and brain functioning in older people | Other | Lifestyle course |
Primary outcome
Subjective feeling of loneliness
Time frame: Change from basline score at UCLA Loneliness Scale at 2 months
Indicates self feeling of loneliness. Measured with UCLA Loneliness Scale Minimum score: 20; Maximum score: 80 Highest scores indicate greater loneliness (Russell, 1996).
Stroop Test (inhibitory control and cognitive flexibility)
Time frame: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Stroop Test Interference score for time and errors (higher scores worse performance) Score range: n.a. (Cafarra et al., 2002)
Executive Cognitive functions: processing speed in Symbol Search
Time frame: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Symbol Search, score range 0-60 Higher scores better performances (Orsini \& Pezzuti, 2013)
Executive Cognitive functions: processing speed in Coding
Time frame: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Coding: score range 0-135 Higher scores better performances (Orsini \& Pezzuti, 2013)
Executive Cognitive functions: working memory
Time frame: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Digit Symbol test from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Digit Span: score range 0-48 Higher scores better performances (Orsini \& Pezzuti, 2013)
Executive Cognitive Functions - Trail Making Test (TMT)
Time frame: Change from basline score at test at 2 months
Executive Cognitive Functions measured through the Trail Making Test (TMT) (Giovagnoli et al., 1996)
Cumulative Illness Rating Scale
Time frame: Change from basline score at scale at 2 months
Clinical tool to measure objective older people illness status Scores range between 14 to 70 with a higher score indicating worse health satus (Parmelee et al. 1995)
Blood Pressure
Time frame: Change from basline score for blood pressure at 2 months
High blood pressure, measured in mmHg,can be an indicator of stress or other health problems
6 items Lubben Social Network Scale
Time frame: Change from basline score at Lubben Social Network scale at 2 months
This scale is a self-report measure of social engagement including family and friends. The score ranges between 0 and 30, with a higher score indicating more social engagement. (Lubben et al. 2006).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 8576833Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
- Background: PubMed 8915764Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.
- BackgroundCaffarra P., Vezzadini G., Dieci F., Zonato A., Venneri A., Una versione abbreviata del test di stroop: dati normativi nella popolazione italiana. Nuova Rivista di Neurologia 2002, 12 (14): 111-115.
- Background: PubMed 7836636Parmelee PA, Thuras PD, Katz IR, Lawton MP. Validation of the Cumulative Illness Rating Scale in a geriatric residential population. J Am Geriatr Soc. 1995 Feb;43(2):130-7. doi: 10.1111/j.1532-5415.1995.tb06377.x.
- BackgroundOrsini A., Pezzuti L.(2013). WAIS-IV. Contributo alla taratura italiana.Giunti OS. Firenze.
- Background: PubMed 16921004Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.
- Derived from this study: PubMed 33126634Rolandi E, Vaccaro R, Abbondanza S, Casanova G, Pettinato L, Colombo M, Guaita A. Loneliness and Social Engagement in Older Adults Based in Lombardy during the COVID-19 Lockdown: The Long-Term Effects of a Course on Social Networking Sites Use. Int J Environ Res Public Health. 2020 Oct 28;17(21):7912. doi: 10.3390/ijerph17217912.
- Fondazione Golgi CenciLink provided by the sponsor.
- Fondazione CariploLink provided by the sponsor.
- Ethical Committee (Università Bicocca)Link provided by the sponsor.
- PI's University pageLink provided by the sponsor.
- Brain ageing in Abbiategrasso studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available upon request by email to Fondazione Golgi Cenci. Applicants will receive a form to fill with all the information about the research design and purpose. The application will be evaluated by a comittee chaired by Prof. Emanuela Sala. The final decision will be communicated within two weeks.
Related trials for Loneliness
Not yet recruiting
Hangeoreum: A Self-Paced Web-Based Program for Loneliness and Connectedness Among Korean Immigrants Aged 50 and Older
Loneliness, Korean
Not yet recruiting
Interpersonal Relational Role Analysis Group Therapy for Nursing Students at Risk of Internet Addiction
Internet Addiction
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Active, not recruiting
PREWELL Digital Well-being Promotion Intervention With the BitHabit App
General Mental Health and Well-Being, Mental Disorders
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
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.
Emanuela Sala, PhD principal investigator
Università degli Studi di Milano-Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook course and Lifestyle Course in people with Loneliness and Social Isolation, run by University of Milano Bicocca at 1 site in Italy.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective feeling of loneliness (time frame: Change from basline score at UCLA Loneliness Scale at 2 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242628, which also lists 7 linked publications.
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 29 Apr 2022.