Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial

NCT05484297 | Completed DMC

• 2 other identifiers: SDR 21-0871I01HX003428-01
• Study Type: interventional
• Target: 974
• Locations: 1 country
• Sites: 3

Brief Summary

The main purpose is to learn if sending messages from the VA (called "Caring Contacts") reduces loneliness and improves mental health. The investigators want to understand if these messages are effective in Veterans aged 60 and above who have missed appointments at the VA even though they have health problems. Participants will receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA, and will be asked to fill out four surveys. The investigators are recruiting 920 Veterans aged 50 years and older who have felt isolated and have missed appointments at the VA to join this study.

Conditions

Loneliness

Outcome Measures

Primary Outcomes (2)

• UCLA Loneliness Scale, Version 3

  This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.

  12-month follow-up

• Count of mental health or primary care visits over 12 months

  Treatment engagement will be assessed by counting VA outpatient visits to mental health or primary care during the 12 months after randomization. More visits will represent greater treatment engagement.

  The 12-month period from the date of randomization to 12-month follow-up

Secondary Outcomes (4)

• PROMIS Short Form v2.0 - Emotional Support 4a

  12-month follow-up

• Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)

  12-month follow-up

• Depressive Symptom Index Suicidality Subscale (DSI-SS)

  12-month follow-up

• Suicide Ideation Scale (SIS)

  12-month follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

Participants in the treatment arm will receive the intervention post cards

Behavioral: Crisis Caring Contacts post cards

Control

SHAM COMPARATOR

Participants in the control arm will receive the control post cards

Behavioral: Control post cards

Interventions

Crisis Caring Contacts post cards BEHAVIORAL

A series of post cards with Crisis Caring Contacts content sent over 10 months

Treatment

Control post cards BEHAVIORAL

A series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50 years and above
• have at least four VA appointments in the prior 6-18 months in primary care or mental health
• have at least two comorbidities contained in the Elixhauser Index
• a) zero completed appointments in the past 6 months and zero appointments scheduled, or b) in the 90th percentile or higher in terms of no-shows or appointments canceled by patient in the prior 12 months

You may not qualify if:

• no valid mailing address
• no valid phone number
• diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Study Officials

• Alan R. Teo, MD MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following recommendations for blinding in behavioral interventions, participants will be blinded by limiting details about the study hypotheses and differences between the study arms. Furthermore, research staff involved in outcome assessment and study biostatisticians involved in data analysis will be blinded to study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to either the intervention or the control group. Block-randomization schemes using random block sizes to assign the two study arms will be created in R using the blockrand package before study start. Randomization will be stratified by study site. The intervention will consist of a series of post cards with Crisis Caring Contacts content sent over 10 months. The control group will receive similar post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 2, 2022
• Study Start: April 4, 2023
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)