- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01408654
Social Connections and Healthy Aging (The Senior Connection) (TSC)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester School of Medicine and Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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