Trial Outcomes & Findings for The Helping Older People Engage Project: Improving Social Well-Being in Later Life (NCT NCT03343483)
NCT ID: NCT03343483
Last Updated: 2023-10-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
291 participants
Primary outcome timeframe
Month 12
Results posted on
2023-10-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
145
|
|
Overall Study
COMPLETED
|
129
|
112
|
|
Overall Study
NOT COMPLETED
|
17
|
33
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
13
|
|
Overall Study
Withdrawal by Subject
|
8
|
17
|
Baseline Characteristics
The Helping Older People Engage Project: Improving Social Well-Being in Later Life
Baseline characteristics by cohort
| Measure |
Volunteering
n=146 Participants
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.
|
Life Review
n=145 Participants
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.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.78 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
71.46 years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
72 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
111 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender male-to-female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender female-to-male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
146 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
UCLA Loneliness Scale
|
49.06 units on a scale
STANDARD_DEVIATION 10.86 • n=5 Participants
|
48.94 units on a scale
STANDARD_DEVIATION 9.57 • n=7 Participants
|
49 units on a scale
STANDARD_DEVIATION 10.22 • n=5 Participants
|
|
Quality of Life (WHOQOL)
|
68.28 units on a scale
STANDARD_DEVIATION 13.79 • n=5 Participants
|
69.29 units on a scale
STANDARD_DEVIATION 12.80 • n=7 Participants
|
68.35 units on a scale
STANDARD_DEVIATION 13.57 • n=5 Participants
|
|
Belonging (Interpersonal Needs Questionnaire)
|
0.68 units on a scale
STANDARD_DEVIATION 0.45 • n=5 Participants
|
0.67 units on a scale
STANDARD_DEVIATION 0.41 • n=7 Participants
|
0.67 units on a scale
STANDARD_DEVIATION 0.43 • n=5 Participants
|
|
Meaning & Purpose (PROMIS)
|
45.15 units on a scale
STANDARD_DEVIATION 9.77 • n=5 Participants
|
45.21 units on a scale
STANDARD_DEVIATION 10.47 • n=7 Participants
|
45.18 units on a scale
STANDARD_DEVIATION 10.11 • n=5 Participants
|
|
Satisfaction with Social Roles & Activities (PROMIS)
|
47.44 units on a scale
STANDARD_DEVIATION 7.63 • n=5 Participants
|
46.31 units on a scale
STANDARD_DEVIATION 6.96 • n=7 Participants
|
46.87 units on a scale
STANDARD_DEVIATION 7.31 • n=5 Participants
|
|
Social Isolation (PROMIS)
|
53.98 units on a scale
STANDARD_DEVIATION 6.31 • n=5 Participants
|
54.53 units on a scale
STANDARD_DEVIATION 6.01 • n=7 Participants
|
54.26 units on a scale
STANDARD_DEVIATION 6.16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12UCLA 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.
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Loneliness
|
44.36 units on a scale
Standard Error 0.96
|
44.10 units on a scale
Standard Error 1.00
|
PRIMARY outcome
Timeframe: Month 12World 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.
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Health-related Quality of Life
|
91.82 score on a scale
Standard Deviation 1.25
|
91.36 score on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Month 12Perceptions 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.
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Belonging (Mechanism)
|
5.62 score on a scale
Standard Error 0.35
|
5.03 score on a scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Month 12The 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).
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Meaning and Purpose (Mechanism)
|
47.25 score on a scale
Standard Error 0.89
|
47.07 score on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Month 12Satisfaction 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).
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Satisfaction With Social Roles and Activities (Mechanism)
|
47.94 score on a scale
Standard Error 0.66
|
47.15 score on a scale
Standard Error 0.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Social 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).
Outcome measures
| Measure |
Volunteering
n=129 Participants
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.
|
Life Review
n=112 Participants
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.
|
|---|---|---|
|
Social Isolation
|
51.64 score on a scale
Standard Error 0.59
|
51.72 score on a scale
Standard Error .62
|
Adverse Events
Volunteering
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Life Review
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kim Van Orden (PI)
University of Rochester Medical Center
Phone: 585-275-5176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place