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

NCT03343483 | Completed Results DMC

• 1 other identifier: R01AG054457
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Quality of Life

Keywords

Volunteerism; Aged; Loneliness; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Belonging (Mechanism)

  Month 12

• Meaning and Purpose (Mechanism)

  Month 12

• Satisfaction With Social Roles and Activities (Mechanism)

  Month 12

Other Outcomes (1)

• Social Isolation

  Month 12

Study Arms (2)

Volunteering

EXPERIMENTAL

Structured social volunteering program providing peer companionship to frail, homebound older adults for at least 16 hours per month for 12 months.

Behavioral: Volunteering

Life Review

ACTIVE COMPARATOR

Self-guided program of life review for 12 months.

Behavioral: Life Review

Interventions

Volunteering BEHAVIORAL

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.

Volunteering

Life Review BEHAVIORAL

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.

Life Review

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Current problem drinking
• Psychosis
• Significant cognitive impairment (MOCA\<22)
• Hearing problems that preclude engagement with a care receiver
• Illiteracy

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 36479062 BACKGROUND

Limitations and Caveats

Few participants (i.e., 9%) completed the minimum 'dose' of volunteering expected to confer benefit (i.e., at least 4 hours per month) and 30% did not begin any volunteer service. 'Dose' for the control condition was comparable. Given that few participants received a 'full dose' of study interventions, 'dose' analyses are planned to examine whether those who completed interventions demonstrated better outcomes.

Results Point of Contact

• Title: Dr. Kim Van Orden (PI)
• Organization: University of Rochester Medical Center

kimberly_vanorden@urmc.rochester.edu

585-275-5176

Study Officials

• Kimberly A Van Orden, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: October 31, 2023
• Results First Posted: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)