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

April 20, 2016 updated by: Yeates Conwell, University of Rochester
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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

368

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Medicine and Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Companionship
Behavioral intervention: Receipt of peer companionship provided by trained, supervised volunteer companions.
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 Names:
  • Intervention is administered to the peer companionship arm.
No Intervention: Care-as-Usual
Care-as-Usual in Primary Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal Ideation
Time Frame: Baseline, 3,6,12,18,24 months
Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale
Baseline, 3,6,12,18,24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Connectedness
Time Frame: Baseline, 3,6,12,18,24 months
Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.
Baseline, 3,6,12,18,24 months
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.
Baseline, 3,6,12,18,24 months
Depression
Time Frame: Baseline, 3,6,12,18,24 months
Assessed with the PHQ-9
Baseline, 3,6,12,18,24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 1, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1U01CE001942-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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