AgedNCT03552328
Effects of a Volunteer-based Lunch Program on Feelings of Loneliness in Elders
A study testing Lunch with Medical Student in people with Aged and Loneliness, run by University of South Florida at 1 site in United States.
Trial summary
Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despite advances in… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, Loneliness, Depression
- What is being tested?
- Lunch with Medical Student
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 15 May 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrollees are eligible for the study if they speak English, have feelings of loneliness on the three-item scale, are able to give written consent, and answer surveys.
Who cannot join
- Elders who are unable to give informed consent or complete trial documentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Pilot Volunteer-based Lunch Program on Feelings of Loneliness in Elders: a Randomized Control Trial
Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despite advances in technology and social media. We propose a randomized control trial to determine the effectiveness of a volunteer-based lunch program on decreasing feelings of loneliness in elderly participants.
Methods: Lonely elders in the community will be identified and matched with a trained medical student. Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Enrollees are eligible for the study if they are over 60 years of age, speak English, have feelings of loneliness on the three-item scale, and display no cognitive impairment. The participants will be assessed pre and post intervention using the R-UCLA scale for loneliness, PHQ-9 for depressive symptoms, and GAD-7 for feelings of anxiety. Participant satisfaction will be assessed using Likert items as well as open-ended questions. Intervention group responses will be compared to responses of participants that did not receive the lunch meeting intervention.
Discussion: Success of such a companion lunch program would provide an effective route to combat loneliness in the elderly.
Read the detailed description
Since the 1960's, the elderly population in the United States has grown steadily. By 2030, one in three people in the U.S. will be over the age of 65. In addition to being at a greater risk for chronic disease, the elderly are also more vulnerable to being socially isolated and lonely. Simply living alone does not appear to be a significant predictor of loneliness, as the elderly could still have a strong support network while living alone, but prevalence data suggests that one in three adults over the age of 65 are lonely. Furthermore, the oldest of the elderly seem to be the loneliest. Dykstra et al. in a 2009 study estimate 40 to 50 percent of those aged 80 or older to be lonely.
Loneliness has been previously defined as the difference between desired and actual relationships, and there is a distinction between loneliness and social isolation. While being considered socially isolated is due to lack of social contact, loneliness is assessed by perceptions of social isolation. Feelings of disconnect, isolation, and not belonging are much more indicative of loneliness than simple aloneness and lack of social contact. Not having a support network or anyone to confide in can lead to feelings of social isolation, and despite advances in technology and the development of social media, feelings of loneliness have increased in the past thirty years. The proportion of Americans who said they had no one to talk to about important matters increased from 10% in 1985 to 25% in 2004. This is an alarming trend because social support has been consistently shown to increase the likelihood of survival. In a meta-analytic review from 2009, participants with strong social relationships and support were found to have a 50 percent increased likelihood of survival. Additionally, a 2013 study found that mortality rates were significantly higher among socially isolated and lonely elders. Loneliness has a profound effect on our healthcare system and has been linked to a higher degree of healthcare utilization. In a Swedish study from 2014, researchers found that lonely elders use more outpatient services than non-lonely elders. In 2015, Gerst et al. found that the large proportion of elders over 60 years old that reported feelings of loneliness had a significantly higher physician visit rate.
There is a demonstrated need for intervention in this lonely, elderly population, with significant public health implications. A randomized control trial from 1999 implementing a visitor volunteer program for the elderly showed that strong community involvement increased the participants' feelings of worth, social integration, and life satisfaction. More recently, a local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. While both pilot programs had short evaluation periods, they demonstrated the effectiveness of volunteer-based community involvement. Combining a visitor volunteer program with a food delivery service could serve to effectively combat the elderly community's feelings of loneliness and social isolation.
A local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. Even though it demonstrated the effectiveness of volunteer-based community involvement, the project was constructed as a pretest-posttest, descriptive study using convenience sampling, and feelings of loneliness were evaluated as a secondary objective using a three-item loneliness screener. In our study, we plan to measure the effects of adding a volunteer visitor to the lunch program; that is, to see if eating meals with a medical student can decrease feelings of loneliness when compared with simply receiving meals through Meals on Wheels. Our study is designed as a randomized control trial in which seniors will be randomly assigned to two groups: paired with a medical student for lunch or not paired with a medical student while still receiving meals.
- Conditions
- Aged, Loneliness, Depression, Anxiety
- Being tested
- Lunch with Medical Student, Control
- 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.
Lunch with Medical StudentOther
Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Students will enroll as Meals on Wheels volunteers and participate in the Meals on Wheels pre-program training. On the day of their scheduled lunch, students will first arrive at the Meals on Wheels designated meal-drop location and pick up two lunches, one for them and one for their assigned elder. They will then drive to their assigned elder's residence and eat lunch with them for one hour.
ControlOther
Students will not bring provided lunches to an elder participant's residence. The elder participants in this arm will simply continue receiving daily meals from Meals on Wheels with no accompanying student.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Seniors receiving daily meals from Meals on Wheels. Intervention: Lunch with Medical Student. Receives: Other: Lunch with Medical Student |
| Control | Placebo comparator | Seniors receiving daily meals from Meals on Wheels Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised-UCLA (R-UCLA) Scale
Investigators will measure change from baseline feelings of loneliness in elderly participants. Responses are scored from 20 (minimum) to 80 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of loneliness.
Measured: Survey will be administered on both study groups twice; once before and once after the six-week period.
Secondary outcomes (2)
Patient Health Questionnaire-9 (PHQ-9)
We will measure change from baseline feelings of depression in elderly participants. Responses are scored from 0 (minimum) to 27 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of depression.
Measured: Survey will be administered on both study groups twice; once before and once after the six-week period.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
We will measure change from baseline feelings of anxiety in elderly participants. Responses are scored from 0 (minimum) to 21 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of anxiety.
Measured: Survey will be administered on both study groups twice; once before and once after the six-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start15 Oct 2018
- Primary completion17 Feb 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Eligible and consenting participants are randomized to one of the two study groups in a 1:1 allocation ratio. A block-stratified method using the computer will be used for generation of randomization sequence. The block size will be random.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Arnold P. Gold Foundation
- Responsible party
- Principal investigator, Brennan Ninesling, University of South Florida
- Investigators
- Lucy Guerra, MD, MPH, Study director, Associate Professor, USF College of Medicine Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552328
- Sponsor's protocol ID
- Pro00034170
- Status last verified
- Jul 2019
- First submitted
- 26 May 2018
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will ensure that all data collected during the trial is handled confidentially and accessed only by members of the team. We will store participants' details on a secure database. We will assign participants an individual specific trial number and we will anonymize their details.
Publications
Lawson, V. and K. Kinsella, Aging in the United States: Past, present, and future. 1996, International Programs Center, Population Division, US Bureau of the Census, Washington, DC.
Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.
PubMed 22710744Dykstra PA. Older adult loneliness: myths and realities. Eur J Ageing. 2009 Jun;6(2):91-100. doi: 10.1007/s10433-009-0110-3. Epub 2009 Apr 4.
PubMed 19517025Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
PubMed 20668659McPherson, M., L. Smith-Lovin, and M.E. Brashears, Social isolation in America: Changes in core discussion networks over two decades. American sociological review, 2006. 71(3): p. 353-375.
Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.
PubMed 23530191Taube E, Kristensson J, Sandberg M, Midlov P, Jakobsson U. Loneliness and health care consumption among older people. Scand J Caring Sci. 2015 Sep;29(3):435-43. doi: 10.1111/scs.12147. Epub 2014 May 14.
PubMed 24826811Gerst-Emerson K, Jayawardhana J. Loneliness as a public health issue: the impact of loneliness on health care utilization among older adults. Am J Public Health. 2015 May;105(5):1013-9. doi: 10.2105/AJPH.2014.302427. Epub 2015 Mar 19.
PubMed 25790413MacIntyre I, Corradetti P, Roberts J, Browne G, Watt S, Lane A. Pilot study of a visitor volunteer programme for community elderly people receiving home health care. Health Soc Care Community. 1999 May;7(3):225-232. doi: 10.1046/j.1365-2524.1999.00178.x.
PubMed 11560637Wright L, Vance L, Sudduth C, Epps JB. The Impact of a Home-Delivered Meal Program on Nutritional Risk, Dietary Intake, Food Security, Loneliness, and Social Well-Being. J Nutr Gerontol Geriatr. 2015;34(2):218-27. doi: 10.1080/21551197.2015.1022681.
PubMed 26106989Cattan M, Kime N, Bagnall AM. The use of telephone befriending in low level support for socially isolated older people--an evaluation. Health Soc Care Community. 2011 Mar;19(2):198-206. doi: 10.1111/j.1365-2524.2010.00967.x. Epub 2010 Nov 29.
PubMed 21114564
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pilot Volunteer-based Lunch Program on Feelings of Loneliness in Elders: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03552328
- Acronym / sponsor ID
- Pro00034170
- Conditions
- Aged, Loneliness, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- The Arnold P. Gold Foundation
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 17 Feb 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 11 Jun 2018 (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.
Background: There is a need for stronger community involvement with the elderly, specifically those with feelings of loneliness. Large proportions of elders in previous studies reported feelings of loneliness, and loneliness at advanced ages is a growing trend seen within the last thirty years despite advances in technology and social media. We propose a randomized control trial to determine the effectiveness of a volunteer-based lunch program on decreasing feelings of loneliness in elderly participants.
Methods: Lonely elders in the community will be identified and matched with a trained medical student. Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Enrollees are eligible for the study if they are over 60 years of age, speak English, have feelings of loneliness on the three-item scale, and display no cognitive impairment. The participants will be assessed pre and post intervention using the R-UCLA scale for loneliness, PHQ-9 for depressive symptoms, and GAD-7 for feelings of anxiety. Participant satisfaction will be assessed using Likert items as well as open-ended questions. Intervention group responses will be compared to responses of participants that did not receive the lunch meeting intervention.
Discussion: Success of such a companion lunch program would provide an effective route to combat loneliness in the elderly.
Detailed description
Since the 1960's, the elderly population in the United States has grown steadily. By 2030, one in three people in the U.S. will be over the age of 65. In addition to being at a greater risk for chronic disease, the elderly are also more vulnerable to being socially isolated and lonely. Simply living alone does not appear to be a significant predictor of loneliness, as the elderly could still have a strong support network while living alone, but prevalence data suggests that one in three adults over the age of 65 are lonely. Furthermore, the oldest of the elderly seem to be the loneliest. Dykstra et al. in a 2009 study estimate 40 to 50 percent of those aged 80 or older to be lonely.
Loneliness has been previously defined as the difference between desired and actual relationships, and there is a distinction between loneliness and social isolation. While being considered socially isolated is due to lack of social contact, loneliness is assessed by perceptions of social isolation. Feelings of disconnect, isolation, and not belonging are much more indicative of loneliness than simple aloneness and lack of social contact. Not having a support network or anyone to confide in can lead to feelings of social isolation, and despite advances in technology and the development of social media, feelings of loneliness have increased in the past thirty years. The proportion of Americans who said they had no one to talk to about important matters increased from 10% in 1985 to 25% in 2004. This is an alarming trend because social support has been consistently shown to increase the likelihood of survival. In a meta-analytic review from 2009, participants with strong social relationships and support were found to have a 50 percent increased likelihood of survival. Additionally, a 2013 study found that mortality rates were significantly higher among socially isolated and lonely elders. Loneliness has a profound effect on our healthcare system and has been linked to a higher degree of healthcare utilization. In a Swedish study from 2014, researchers found that lonely elders use more outpatient services than non-lonely elders. In 2015, Gerst et al. found that the large proportion of elders over 60 years old that reported feelings of loneliness had a significantly higher physician visit rate.
There is a demonstrated need for intervention in this lonely, elderly population, with significant public health implications. A randomized control trial from 1999 implementing a visitor volunteer program for the elderly showed that strong community involvement increased the participants' feelings of worth, social integration, and life satisfaction. More recently, a local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. While both pilot programs had short evaluation periods, they demonstrated the effectiveness of volunteer-based community involvement. Combining a visitor volunteer program with a food delivery service could serve to effectively combat the elderly community's feelings of loneliness and social isolation.
A local food delivery project in Tampa showed that weekly food delivery to an at-risk elderly population decreased participants' feelings of loneliness and increased their measured well-being over the course of two months. Even though it demonstrated the effectiveness of volunteer-based community involvement, the project was constructed as a pretest-posttest, descriptive study using convenience sampling, and feelings of loneliness were evaluated as a secondary objective using a three-item loneliness screener. In our study, we plan to measure the effects of adding a volunteer visitor to the lunch program; that is, to see if eating meals with a medical student can decrease feelings of loneliness when compared with simply receiving meals through Meals on Wheels. Our study is designed as a randomized control trial in which seniors will be randomly assigned to two groups: paired with a medical student for lunch or not paired with a medical student while still receiving meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible and consenting participants are randomized to one of the two study groups in a 1:1 allocation ratio. A block-stratified method using the computer will be used for generation of randomization sequence. The block size will be random.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Lunch with Medical StudentSeniors receiving daily meals from Meals on Wheels. Intervention: Lunch with Medical Student. |
| Control | Placebo comparator | Other: ControlSeniors receiving daily meals from Meals on Wheels |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrollees are eligible for the study if they speak English, have feelings of loneliness on the three-item scale, are able to give written consent, and answer surveys.
Key exclusion criteria (1 listed)
- Elders who are unable to give informed consent or complete trial documentation.
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 |
|---|---|---|
| Lunch with Medical StudentEach student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Students will enroll as Meals on Wheels volunteers and participate in the Meals on Wheels pre-program training. On the day of their scheduled lunch, students will first arrive at the Meals on Wheels designated meal-drop location and pick up two lunches, one for them and one for their assigned elder. They will then drive to their assigned elder's residence and eat lunch with them for one hour. | Other | Intervention |
| ControlStudents will not bring provided lunches to an elder participant's residence. The elder participants in this arm will simply continue receiving daily meals from Meals on Wheels with no accompanying student. | Other | Control |
Primary outcome
Revised-UCLA (R-UCLA) Scale
Time frame: Survey will be administered on both study groups twice; once before and once after the six-week period.
Investigators will measure change from baseline feelings of loneliness in elderly participants. Responses are scored from 20 (minimum) to 80 (maximum). Only total scores are reported. Lower values represent a better outcome, i.e. less feelings of loneliness.
2 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Survey will be administered on both study groups twice; once before and once after the six-week period.
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: Survey will be administered on both study groups twice; once before and once after the six-week period.
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 22 Jul 2019.
- BackgroundLawson, V. and K. Kinsella, Aging in the United States: Past, present, and future. 1996, International Programs Center, Population Division, US Bureau of the Census, Washington, DC.
- Background: PubMed 22710744Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.
- Background: PubMed 19517025Dykstra PA. Older adult loneliness: myths and realities. Eur J Ageing. 2009 Jun;6(2):91-100. doi: 10.1007/s10433-009-0110-3. Epub 2009 Apr 4.
- Background: PubMed 18504506Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
- Background: PubMed 20668659Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.
- BackgroundMcPherson, M., L. Smith-Lovin, and M.E. Brashears, Social isolation in America: Changes in core discussion networks over two decades. American sociological review, 2006. 71(3): p. 353-375.
- Background: PubMed 23530191Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013 Apr 9;110(15):5797-801. doi: 10.1073/pnas.1219686110. Epub 2013 Mar 25.
- Background: PubMed 24826811Taube E, Kristensson J, Sandberg M, Midlov P, Jakobsson U. Loneliness and health care consumption among older people. Scand J Caring Sci. 2015 Sep;29(3):435-43. doi: 10.1111/scs.12147. Epub 2014 May 14.
- Background: PubMed 25790413Gerst-Emerson K, Jayawardhana J. Loneliness as a public health issue: the impact of loneliness on health care utilization among older adults. Am J Public Health. 2015 May;105(5):1013-9. doi: 10.2105/AJPH.2014.302427. Epub 2015 Mar 19.
- Background: PubMed 11560637MacIntyre I, Corradetti P, Roberts J, Browne G, Watt S, Lane A. Pilot study of a visitor volunteer programme for community elderly people receiving home health care. Health Soc Care Community. 1999 May;7(3):225-232. doi: 10.1046/j.1365-2524.1999.00178.x.
- Background: PubMed 26106989Wright L, Vance L, Sudduth C, Epps JB. The Impact of a Home-Delivered Meal Program on Nutritional Risk, Dietary Intake, Food Security, Loneliness, and Social Well-Being. J Nutr Gerontol Geriatr. 2015;34(2):218-27. doi: 10.1080/21551197.2015.1022681.
- Background: PubMed 21114564Cattan M, Kime N, Bagnall AM. The use of telephone befriending in low level support for socially isolated older people--an evaluation. Health Soc Care Community. 2011 Mar;19(2):198-206. doi: 10.1111/j.1365-2524.2010.00967.x. Epub 2010 Nov 29.
- Individual participant dataSharing planned: No. We will ensure that all data collected during the trial is handled confidentially and accessed only by members of the team. We will store participants' details on a secure database. We will assign participants an individual specific trial number and we will anonymize their details.
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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.
Lucy Guerra, MD, MPH study director
Associate Professor, USF College of Medicine Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lunch with Medical Student in people with Aged and Loneliness, run by University of South Florida at 1 site in United States.
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: finished, as of the sponsor's last update on 22 Jul 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Revised-UCLA (R-UCLA) Scale (time frame: Survey will be administered on both study groups twice; once before and once after the six-week period.). 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 NCT03552328, which also lists 12 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 22 Jul 2019.