An interventional study of Volunteering and Life Review in Loneliness and Quality of Life, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
Older adults who feel lonely carry increased risk for reduced quality of life, morbidity, and mortality. Volunteering is a promising intervention for reducing loneliness in later life. The primary objective of this proposal is to test the hypothesis that a social volunteering program for lonely older adults will lead to reduced loneliness and improved quality of life.
This study compares the effect of a Senior Corps volunteering intervention versus a self-guided life review active control condition on feelings of loneliness in older adults.
The study involves randomly assigning older adults (150 women, 150 men) who report loneliness to 12 months of either: 1) a structured social volunteering program, or 2) an active control intervention with self-guided life review. Specific aims are as follows: 1) To examine the effect of volunteering on loneliness and quality of life; 2) To examine social engagement, perceived usefulness, and social support as mechanisms for reducing loneliness; 3) To examine conditions under which volunteering is most effective at reducing loneliness.
The many negative outcomes associated with loneliness in older people have rendered loneliness itself a new public health target. Older adults who feel lonely carry increased risk for reduced quality of life, morbidity, and mortality. The risk of premature mortality related to loneliness is at least as large as the risks arising from such factors as obesity, physical inactivity, alcohol misuse, and smoking. Volunteering is a promising intervention for reducing loneliness in later life. The primary objective of this proposal is to test the hypothesis that a social volunteering program for lonely older adults will lead to reduced loneliness and improved quality of life. National infrastructure for volunteering (The Senior Corps) ensures that volunteering is a highly scalable intervention.
The investigators propose to compare the effect of a Senior Corps volunteering intervention versus a self-guided life review active control condition on feelings of loneliness in older adults. The investigators' preliminary data, as well as published studies of volunteering in later life, strongly suggest that volunteering should reduce loneliness. Rigorous experimental study is needed, however, to examine volunteering in both men and women who are lonely, to determine conditions that maximize benefit, and to understand mechanisms. The investigators hypothesize, per tenets of Self-Determination Theory, that increased social engagement and feelings of both usefulness and social support function as psychological mechanisms whereby volunteering reduces loneliness. Understanding these mechanisms will promote effective implementation, allowing communities to adapt volunteering programs while retaining the active ingredients.
The study involves randomly assigning older adults (150 women, 150 men) who report loneliness to 12 months of either: 1) a structured social volunteering program, or 2) an active control intervention with self-guided life review.
Specific aims are as follows: 1) To examine the effect of volunteering on loneliness and quality of life; 2) To examine social engagement, perceived usefulness, and social support as mechanisms for reducing loneliness; 3) To examine conditions under which volunteering is most effective at reducing loneliness.
The volunteering intervention is already implemented nation-wide, indicating high feasibility of going to scale (http://www.nationalservice.gov/programs/senior-corps). If effective, volunteering should be "prescribed" by physicians and promoted by policy. Dissemination and scaling up efforts will involve connecting primary care patients and aging services clients who are lonely with The Senior Corps, shown to be feasible in the investigators' companion study, The Senior Connection. Existing infrastructure will make it possible to reach a large proportion of lonely older adults. Reducing loneliness has the potential to improve well-being and save lives.
University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Structured social volunteering program providing peer companionship to frail, homebound older adults for at least 16 hours per month for 12 months.
Behavioral: Volunteering
Self-guided program of life review for 12 months.
Behavioral: Life Review
Volunteers provide non-medical caregiving for frail seniors-"care receivers"-to help them maintain their independence and improve their well-being. Friendly visiting is the primary service provided. Structured, intensive training is provided prior to placement. The target expectation is of interactions in person and/or by telephone for at least 16 hours per month. On-going training ("booster sessions") as well as volunteer support groups, and educational activities are provided. Participants not interested in serving as peer companions are allowed other volunteer options as long as the activities are deemed 'social' by the volunteer coordinator and are options routinely provided as part of the AmeriCorps Senior RSVP Program. COVID update: due to physical distancing requirements, volunteer placements have transitioned to remote friendly calling/letter writing or activities that can be conducted with physical distancing, such as delivery for Meals on Wheels.
Subjects will complete a self-guided life review exercise over 12 months. Subjects will complete one section of the life review (with the self-help book) each month and send 'assignments' once per month to an email 'counselor' who will respond with supportive comments within three days.
Loneliness
UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Subjects completed this scale at 1 year follow-up, reflecting on the prior month.
Time frame: Month 12
Health-related Quality of Life
World Health Organization Quality of Life--Bref instrument (WHOQOL-Bref). This self-report instrument comprises 26 items. The WHOQOL-Bref produces scores for four domains (i.e., physical health, psychological functioning, social relationships, and environmental opportunities) and a total score reflecting overall health-related quality of life. Our primary outcome is the total score assessing overall quality of life. All items are rated on a 5-pt scale, with scores of 5 representing the best outcome. Some items are reversed scored (per the WHOQOL manual). Scores are transformed (per the WHOQOL manual) such that the range for the total score is 0-100, with 100 representing the highest quality of life.
Time frame: Month 12
Belonging (Mechanism)
Perceptions of belonging will be measured with the 9 items in the "belonging" subscale of the Interpersonal Needs Questionnaire. Each item is rated on a 3-pt scale: 'not at all true for me' (0), 'somewhat true for me' (1), or 'very true for me' (2). Some items are reverse scored so that higher scores represent better outcomes (i.e., greater belonging). Scores represent a sum of all items and can range from 0 - 18.
Time frame: Month 12
Meaning and Purpose (Mechanism)
The PROMIS Meaning and Purpose short form was used to assess the degree to which subjects felt increased usefulness and purpose. It has 4 items, rated from 1 ('not at all'), 2 ('a little bit'), 3 ('somewhat'), 4 ('quite a bit'), and 5 ('very much'). Total scores are transformed using a T-score metric in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population. For the Meaning and Purpose form, the reference group was a general (not clinical) population. Greater scores indicate a better outcome (i.e., greater meaning and purpose).
Time frame: Month 12
Satisfaction With Social Roles and Activities (Mechanism)
Satisfaction with Social Roles and Activities (PROMIS) was used to assess the construct of social engagement. It is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities).
Time frame: Month 12
Social Isolation
Social isolation (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate worse outcomes (i.e., greater social isolation).
Time frame: Month 12
| Milestone | Volunteering | Life Review |
|---|---|---|
| Started | 146 | 145 |
| Completed | 129 | 112 |
| Not completed | 17 | 33 |
| Withdrew: Death | 0 | 3 |
| Withdrew: Lost to follow-up | 9 | 13 |
| Withdrew: Withdrawal by subject | 8 | 17 |
UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness). Subjects completed this scale at 1 year follow-up, reflecting on the prior month.
| units on a scale | Volunteering | Life Review |
|---|---|---|
| Loneliness | 44.36 ± 0.96 | 44.10 ± 1.00 |
World Health Organization Quality of Life--Bref instrument (WHOQOL-Bref). This self-report instrument comprises 26 items. The WHOQOL-Bref produces scores for four domains (i.e., physical health, psychological functioning, social relationships, and environmental opportunities) and a total score reflecting overall health-related quality of life. Our primary outcome is the total score assessing overall quality of life. All items are rated on a 5-pt scale, with scores of 5 representing the best outcome. Some items are reversed scored (per the WHOQOL manual). Scores are transformed (per the WHOQOL manual) such that the range for the total score is 0-100, with 100 representing the highest quality of life.
| score on a scale | Volunteering | Life Review |
|---|---|---|
| Health-related Quality of Life | 91.82 ± 1.25 | 91.36 ± 1.33 |
Perceptions of belonging will be measured with the 9 items in the "belonging" subscale of the Interpersonal Needs Questionnaire. Each item is rated on a 3-pt scale: 'not at all true for me' (0), 'somewhat true for me' (1), or 'very true for me' (2). Some items are reverse scored so that higher scores represent better outcomes (i.e., greater belonging). Scores represent a sum of all items and can range from 0 - 18.
| score on a scale | Volunteering | Life Review |
|---|---|---|
| Belonging (Mechanism) | 5.62 ± 0.35 | 5.03 ± 0.36 |
The PROMIS Meaning and Purpose short form was used to assess the degree to which subjects felt increased usefulness and purpose. It has 4 items, rated from 1 ('not at all'), 2 ('a little bit'), 3 ('somewhat'), 4 ('quite a bit'), and 5 ('very much'). Total scores are transformed using a T-score metric in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population. For the Meaning and Purpose form, the reference group was a general (not clinical) population. Greater scores indicate a better outcome (i.e., greater meaning and purpose).
| score on a scale | Volunteering | Life Review |
|---|---|---|
| Meaning and Purpose (Mechanism) | 47.25 ± 0.89 | 47.07 ± 0.92 |
Satisfaction with Social Roles and Activities (PROMIS) was used to assess the construct of social engagement. It is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities).
| score on a scale | Volunteering | Life Review |
|---|---|---|
| Satisfaction With Social Roles and Activities (Mechanism) | 47.94 ± 0.66 | 47.15 ± 0.70 |
Social isolation (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate worse outcomes (i.e., greater social isolation).
| score on a scale | Volunteering | Life Review |
|---|---|---|
| Social Isolation | 51.64 ± 0.59 | 51.72 ± .62 |
Collected over Subjects were assessed for adverse events at all study visits; participation was 1 year, with assessments at 3-months post-randomization, 6-months post randomization, 9 months post randomization, and 12-months post-randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Volunteering | 0/146 (0%) | 0/146 (0%) | 0/146 (0%) |
| Life Review | 3/145 (2.1%) | 0/145 (0%) | 0/145 (0%) |
| Age, Continuous(years) | Volunteering | Life Review | Total |
|---|---|---|---|
| Mean | 72.78 ± 9.27 | 71.46 ± 8.96 | 72 ± 9.07 |
| Sex/Gender, Customized(Participants) | Volunteering | Life Review | Total |
|---|---|---|---|
| Female | 111 | 108 | 219 |
| Male | 34 | 36 | 70 |
| Transgender male-to-female | 1 | 1 | 2 |
| Transgender female-to-male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Volunteering | Life Review | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 144 | 141 | 285 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Volunteering | Life Review | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 10 | 17 |
| White | 135 | 130 | 265 |
| More than one race | 3 | 4 | 7 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Volunteering | Life Review | Total |
|---|---|---|---|
| United States | 146 | 145 | 291 |
| UCLA Loneliness Scale(units on a scale) | Volunteering | Life Review | Total |
|---|---|---|---|
| Mean | 49.06 ± 10.86 | 48.94 ± 9.57 | 49 ± 10.22 |
| Quality of Life (WHOQOL)(units on a scale) | Volunteering | Life Review | Total |
|---|---|---|---|
| Mean | 68.28 ± 13.79 | 69.29 ± 12.80 | 68.35 ± 13.57 |
| Belonging (Interpersonal Needs Questionnaire)(units on a scale) | Volunteering | Life Review | Total |
|---|---|---|---|
| Mean | 0.68 ± 0.45 | 0.67 ± 0.41 | 0.67 ± 0.43 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The final dataset will include self-reported demographic and behavioral data from interviews with the subjects. The final dataset will be stripped of identifiers prior to release for sharing; however, we will make the data and associated documentation available to users only under a data-sharing agreement as suggested by the NIH that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data from this research will be made available to the public in the University of Rochester's institutional repository, UR Research, at https://urresearch.rochester.edu. UR Research is fully searchable in its own right, and is also regularly indexed by Google, so that its contents are accessible from the results of Google searches.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: 6 months after publication of primary outcomes
Access criteria: We will make the data and associated documentation available to users only under a data-sharing agreement as suggested by the NIH that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Data sharing details ↗ · urresearch.rochester.edu
Ran from Jan 2018 to primary completion in May 2023, 64 months.
Results were first posted in Oct 2023, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.