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

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ClinicalTrials.gov Identifier: NCT03343483
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kimberly Van Orden, University of Rochester

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.


Condition or disease Intervention/treatment Phase
Loneliness Quality of Life Behavioral: Volunteering Behavioral: Life Review Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Getting Active Project (GAP): A Randomized Trial of Volunteering to Reduce Loneliness in Later Life
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

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.

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.




Primary Outcome Measures :
  1. Loneliness [ Time Frame: 12 months ]
    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).

  2. Health-related Quality of Life [ Time Frame: 12 months ]
    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 Outcome Measures :
  1. Belonging [ Time Frame: 12 months ]
    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.

  2. Meaning and Purpose [ Time Frame: 12 months ]
    The PROMIS Meaning and Purpose short form 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).

  3. Satisfaction with Social Roles and Activities [ Time Frame: 12 months ]
    Satisfaction with Social Roles and Activities (PROMIS) 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).

  4. Social Isolation [ Time Frame: 12 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343483


Contacts
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Contact: Kimberly A Van Orden, PhD 585-275-5176 kimberly_vanorden@urmc.rochester.edu
Contact: April Buttaccio, MPH april_buttaccio@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Kimberly Van Orden, PhD    585-275-5176    kimberly_vanorden@urmc.rochester.edu   
Principal Investigator: Kimberly A Van Orden, PhD         
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kimberly A Van Orden, PhD University of Rochester
  Study Documents (Full-Text)

Documents provided by Kimberly Van Orden, University of Rochester:
Informed Consent Form  [PDF] January 24, 2019


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Responsible Party: Kimberly Van Orden, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03343483     History of Changes
Other Study ID Numbers: R01AG054457 ( U.S. NIH Grant/Contract )
R01AG054457 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.
URL: https://urresearch.rochester.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kimberly Van Orden, University of Rochester:
Volunteerism
Aged
Loneliness
Quality of Life