Loneliness, Quality of Life
Conditions
Keywords
Volunteerism, Aged, Loneliness, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVolunteering
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.
BEHAVIORALLife Review
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.
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60 or older * English-speaking * UCLA Short Form Loneliness Scale score of 6 or more * Ability to supply own transportation to care receiver's home; active drivers license and automobile insurance (or alternate transportation such as city bus)
Exclusion criteria
* Current problem drinking * Psychosis * Significant cognitive impairment (MOCA\<22) * Hearing problems that preclude engagement with a care receiver * Illiteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | Month 12 | 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. |
| Health-related Quality of Life | Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Belonging (Mechanism) | Month 12 | 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. |
| Meaning and Purpose (Mechanism) | Month 12 | 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). |
| Satisfaction With Social Roles and Activities (Mechanism) | Month 12 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social Isolation | Month 12 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Volunteering Structured social volunteering program providing peer companionship to frail, homebound older adults for at least 16 hours per month for 12 months.
Volunteering: 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. | 146 |
| Life Review Self-guided program of life review for 12 months.
Life Review: 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. | 145 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 3 |
| Overall Study | Lost to Follow-up | 9 | 13 |
| Overall Study | Withdrawal by Subject | 8 | 17 |
Baseline characteristics
| Characteristic | Volunteering | Total | Life Review |
|---|---|---|---|
| Age, Continuous | 72.78 years STANDARD_DEVIATION 9.27 | 72 years STANDARD_DEVIATION 9.07 | 71.46 years STANDARD_DEVIATION 8.96 |
| Belonging (Interpersonal Needs Questionnaire) | 0.68 units on a scale STANDARD_DEVIATION 0.45 | 0.67 units on a scale STANDARD_DEVIATION 0.43 | 0.67 units on a scale STANDARD_DEVIATION 0.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 144 Participants | 285 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Meaning & Purpose (PROMIS) | 45.15 units on a scale STANDARD_DEVIATION 9.77 | 45.18 units on a scale STANDARD_DEVIATION 10.11 | 45.21 units on a scale STANDARD_DEVIATION 10.47 |
| Quality of Life (WHOQOL) | 68.28 units on a scale STANDARD_DEVIATION 13.79 | 68.35 units on a scale STANDARD_DEVIATION 13.57 | 69.29 units on a scale STANDARD_DEVIATION 12.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 135 Participants | 265 Participants | 130 Participants |
| Region of Enrollment United States | 146 Participants | 291 Participants | 145 Participants |
| Satisfaction with Social Roles & Activities (PROMIS) | 47.44 units on a scale STANDARD_DEVIATION 7.63 | 46.87 units on a scale STANDARD_DEVIATION 7.31 | 46.31 units on a scale STANDARD_DEVIATION 6.96 |
| Sex/Gender, Customized Female | 111 Participants | 219 Participants | 108 Participants |
| Sex/Gender, Customized Male | 34 Participants | 70 Participants | 36 Participants |
| Sex/Gender, Customized Transgender female-to-male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender male-to-female | 1 Participants | 2 Participants | 1 Participants |
| Social Isolation (PROMIS) | 53.98 units on a scale STANDARD_DEVIATION 6.31 | 54.26 units on a scale STANDARD_DEVIATION 6.16 | 54.53 units on a scale STANDARD_DEVIATION 6.01 |
| UCLA Loneliness Scale | 49.06 units on a scale STANDARD_DEVIATION 10.86 | 49 units on a scale STANDARD_DEVIATION 10.22 | 48.94 units on a scale STANDARD_DEVIATION 9.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 146 | 3 / 145 |
| other Total, other adverse events | 0 / 146 | 0 / 145 |
| serious Total, serious adverse events | 0 / 146 | 0 / 145 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Health-related Quality of Life | 91.82 score on a scale | Standard Deviation 1.25 |
| Life Review | Health-related Quality of Life | 91.36 score on a scale | Standard Deviation 1.33 |
p-value: 0.8ANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Loneliness | 44.36 units on a scale | Standard Error 0.96 |
| Life Review | Loneliness | 44.10 units on a scale | Standard Error 1 |
p-value: 0.89695% CI: [-2.21, 1.93]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Belonging (Mechanism) | 5.62 score on a scale | Standard Error 0.35 |
| Life Review | Belonging (Mechanism) | 5.03 score on a scale | Standard Error 0.36 |
p-value: 0.33Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Meaning and Purpose (Mechanism) | 47.25 score on a scale | Standard Error 0.89 |
| Life Review | Meaning and Purpose (Mechanism) | 47.07 score on a scale | Standard Error 0.92 |
p-value: 0.58Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Satisfaction With Social Roles and Activities (Mechanism) | 47.94 score on a scale | Standard Error 0.66 |
| Life Review | Satisfaction With Social Roles and Activities (Mechanism) | 47.15 score on a scale | Standard Error 0.7 |
p-value: 0.73Mixed Models Analysis
Other Pre-specified
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Volunteering | Social Isolation | 51.64 score on a scale | Standard Error 0.59 |
| Life Review | Social Isolation | 51.72 score on a scale | Standard Error 0.62 |
p-value: 0.57Mixed Models Analysis