Social Connections and Healthy Aging (The Senior Connection)

Depression Clinical Trial

— TSC  

Official title:

Social Connections and Healthy Aging (The Senior Connection)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01408654
• Other study ID #: 1U01CE001942-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 1, 2011
• Last updated: November 20, 2015
• Start date: March 2011
• Est. completion date: September 2016

Study information

• Verified date: November 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester School of Medicine and Dentistry	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation	Severity of suicidal and death ideation assessed with the Geriatric Suicide Ideation Scale	Baseline, 3,6,12,18,24 months	No
Secondary	Social Connectedness	Thwarted belongingness and perceived burdensomeness assessed by the Interpersonal Needs Questionnaire.	Baseline, 3,6,12,18,24 months	No
Secondary	Connectedness	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	No
Secondary	Depression	Assessed with the PHQ-9	Baseline, 3,6,12,18,24 months	No