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

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ClinicalTrials.gov Identifier: NCT01408654
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Yeates Conwell, University of Rochester

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE August 3, 2011
Last Update Posted Date April 22, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Suicidal Ideation [ Time Frame: Baseline, 3,6,12,18,24 months ]
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Social Connectedness [ Time Frame: Baseline, 3,6,12,18,24 months ]
    Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.
  • Connectedness [ Time Frame: Baseline, 3,6,12,18,24 months ]
    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 ]
    Assessed with the PHQ-9
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Connections and Healthy Aging (The Senior Connection)
Official Title  ICMJE Social Connections and Healthy Aging (The Senior Connection)
Brief Summary 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Suicidal Ideation
  • Depression
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Peer Companionship
    Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions.
    Intervention: Behavioral: Peer Companionship
  • No Intervention: Care-as-Usual
    Care-as-Usual in Primary Care
Publications * Van Orden KA, Stone DM, Rowe J, McIntosh WL, Podgorski C, Conwell Y. The Senior Connection: design and rationale of a randomized trial of peer companionship to reduce suicide risk in later life. Contemp Clin Trials. 2013 May;35(1):117-26. doi: 10.1016/j.cct.2013.03.003. Epub 2013 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2016)
368
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
400
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01408654
Other Study ID Numbers  ICMJE 1U01CE001942-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yeates Conwell, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP