Social Connections and Healthy Aging (The Senior Connection) (TSC)
Primary Purpose
Suicidal Ideation, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peer Companionship
Sponsored by
About this trial
This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicidal Ideation, Loneliness, Social Support, Voluntary Workers, Friends/Companions, Prevention, Aged
Eligibility 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.)
Sites / Locations
- University of Rochester School of Medicine and Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Peer Companionship
Care-as-Usual
Arm Description
Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions.
Care-as-Usual in Primary Care
Outcomes
Primary Outcome Measures
Suicidal Ideation
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
Secondary Outcome Measures
Social Connectedness
Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.
Connectedness
Social network size/density/quality assessed with the National Social Life, Health, and Aging Project Social Network Module.
Depression
Assessed with the PHQ-9
Full Information
NCT ID
NCT01408654
First Posted
August 1, 2011
Last Updated
April 20, 2016
Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01408654
Brief Title
Social Connections and Healthy Aging (The Senior Connection)
Acronym
TSC
Official Title
Social Connections and Healthy Aging (The Senior Connection)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Depression
Keywords
Suicidal Ideation, Loneliness, Social Support, Voluntary Workers, Friends/Companions, Prevention, Aged
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Companionship
Arm Type
Experimental
Arm Description
Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions.
Arm Title
Care-as-Usual
Arm Type
No Intervention
Arm Description
Care-as-Usual in Primary Care
Intervention Type
Behavioral
Intervention Name(s)
Peer Companionship
Other Intervention Name(s)
Intervention is administered to the peer companionship arm.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
Time Frame
Baseline, 3,6,12,18,24 months
Secondary Outcome Measure Information:
Title
Social Connectedness
Description
Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.
Time Frame
Baseline, 3,6,12,18,24 months
Title
Connectedness
Description
Social network size/density/quality assessed with the National Social Life, Health, and Aging Project Social Network Module.
Time Frame
Baseline, 3,6,12,18,24 months
Title
Depression
Description
Assessed with the PHQ-9
Time Frame
Baseline, 3,6,12,18,24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
University of Rochester School of Medicine and Dentistry
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23506973
Citation
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.
Results Reference
background
PubMed Identifier
35735167
Citation
Parkhurst KA, Daks JS, Conwell Y, Podgorski CA, Van Orden KA. Social network subtypes among socially disconnected older adults at risk for suicide: A latent class analysis. Suicide Life Threat Behav. 2022 Oct;52(5):963-974. doi: 10.1111/sltb.12893. Epub 2022 Jun 23.
Results Reference
derived
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Social Connections and Healthy Aging (The Senior Connection)
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