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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1U01CE001942-01 (U.S. NIH Grant/Contract)

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