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Social Connections and Healthy Aging (The Senior Connection) (TSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yeates Conwell, University of Rochester
ClinicalTrials.gov Identifier:
NCT01408654
First received: August 1, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This randomized trial compares peer companionship to care-as-usual in primary care on the outcome of risk for suicidal behavior in late life. The investigators hypothesize that older adults assigned to receive peer companionship will report greater social connectedness and less death and suicidal ideation compared to older adults assigned to care as usual.


Condition Intervention Phase
Suicidal Ideation
Depression
Behavioral: Peer Companionship
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Social Connections and Healthy Aging (The Senior Connection)

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Suicidal Ideation [ Time Frame: Baseline, 3,6,12,18,24 months ] [ Designated as safety issue: No ]
    Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale


Secondary Outcome Measures:
  • Social Connectedness [ Time Frame: Baseline, 3,6,12,18,24 months ] [ Designated as safety issue: No ]
    Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.

  • Connectedness [ Time Frame: Baseline, 3,6,12,18,24 months ] [ Designated as safety issue: No ]
    Social network size/density/quality assessed with the National Social Life, Health, and Aging Project Social Network Module.

  • Depression [ Time Frame: Baseline, 3,6,12,18,24 months ] [ Designated as safety issue: No ]
    Assessed with the PHQ-9


Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peer Companionship
Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions.
Behavioral: Peer Companionship
Peer companionship is provided at least four times per month over two years in the form of friendly visiting, supportive phone calls, and some instrumental support.
Other Name: Intervention is administered to the peer companionship arm.
No Intervention: Care-as-Usual
Care-as-Usual in Primary Care

Detailed Description:

There is a pressing need for interventions that reduce risk for suicide in later life. Older adults in the U.S. have the highest rate of suicide and are the fastest growing segment of the population. The investigators can anticipate a large rise in the number of older adults who die by suicide in coming decades. This application is in response to RFA-CE-10-006. Consistent with the CDC's key strategy of reducing suicide by promoting connectedness, our long-term goal is to reduce late life suicide-related morbidity and mortality by leveraging the resources and expertise of the aging services provider network (ASPN) to address unmet social needs of community-dwelling older adults. Our objectives with this proposal are (1) to examine whether linking socially disconnected seniors with peer supports through the Retired and Senior Volunteer Program (RSVP) is effective in reducing risk for suicide, and (2) to test an hypothesized mechanism for the association of social disconnectedness and suicidal ideation and behavior informed by the Interpersonal Theory of Suicide.

The investigators will recruit 400 primary care patients (200 men and 200 women) over age 60 years who endorse feeling lonely and/or as if they are a burden on others. They will be randomly assigned to either of two conditions. Those assigned to The Senior Connection (TSC) will either be paired with a peer companion or, if they prefer and are eligible, be trained and placed as a peer companion for others by RSVP. The comparison group will receive no further intervention ("care-as-usual" [CAU]). Subjects will be followed for up to 24 months with repeated in-home (baseline, 12, and 24 months) and telephone assessments (3, 6, and 18 months).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 60 or older
  • Primary Care Patient
  • Endorses feeling lonely and/or like a burden in the the past two weeks

Exclusion Criteria:

  • Positive dementia screen
  • Current alcohol abuse
  • Psychosis
  • Suicidal ideation with intent to act (current or past month.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408654

Locations
United States, New York
University of Rochester School of Medicine and Dentistry Recruiting
Rochester, New York, United States, 14642
Contact: Yeates Conwell, MD    585-275-6739    yeates_conwell@urmc.rochester.edu   
Principal Investigator: Yeates Conwell, MD         
Sub-Investigator: Kimberly A. Van Orden, Ph.D.         
Sub-Investigator: Carol A Podgorski, Ph.D.         
Sub-Investigator: Jody Rowe         
Sub-Investigator: Jeffrey Lyness, MD         
Sponsors and Collaborators
University of Rochester
  More Information

No publications provided

Responsible Party: Yeates Conwell, Co-Chair, Department of Psychiatry, Professor of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT01408654     History of Changes
Other Study ID Numbers: 1U01CE001942-01
Study First Received: August 1, 2011
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Suicidal Ideation
Loneliness
Social Support
Voluntary Workers
Friends/Companions
Prevention
Aged

Additional relevant MeSH terms:
Depression
Suicidal Ideation
Behavioral Symptoms
Self-Injurious Behavior
Suicide

ClinicalTrials.gov processed this record on November 24, 2014