The Helping Older People Engage Project: Improving Social Well-Being in Later Life (HOPE)

The Getting Active Project (GAP): A Randomized Trial of Volunteering to Reduce Loneliness in Later Life

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Loneliness
• Intervention / Treatment: Behavioral: Volunteering; Behavioral: Life Review

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volunteering; Structured social volunteering program providing peer companionship to frail, homebound older adults for at least 16 hours per month for 12 months.	Behavioral: 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.
Active Comparator: Life Review; Self-guided program of life review for 12 months.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 12

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kimberly A Van Orden, PhD, University of Rochester

Publications and helpful links

General Publications

• Van Orden KA, Conwell Y, Chapman BP, Buttaccio A, VanBergen A, Beckwith E, Santee A, Rowe J, Palumbos D, Williams G, Messing S, Sorensen S, Tu X. The helping older people engage (HOPE) study: Protocol & COVID modifications for a randomized trial. Contemp Clin Trials Commun. 2022 Nov 30;30:101040. doi: 10.1016/j.conctc.2022.101040. eCollection 2022 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: November 11, 2017
• First Submitted That Met QC Criteria: November 11, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Loneliness; Aged; Volunteerism
• Other Study ID Numbers: R01AG054457 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 6 months after publication of primary outcomes
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No