Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial

Loneliness Clinical Trial

Official title:

Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484297
• Other study ID #: SDR 21-087
• Secondary ID: 1I01HX003428-01
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: Aaron A Call
• Phone: (503) 220-8262
• Email: Aaron.Call[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Lack of social connection is a common and powerful predictor of suicidal ideation, suicide attempts, functional decline, and death, even after adjustment for sociodemographic and clinical variables. Loneliness, specifically, is associated with a 26% increased likelihood of all-cause mortality. The urgency of addressing these problems is only amplified by the COVID-19 pandemic, which for some time may further increase loneliness, suicide, and other causes of mortality. Due to their risk for loneliness and negative health outcomes, a group of particular concern is older adults and patients with medical or psychiatric comorbidity who have poor treatment engagement.

Caring Contacts is an intervention that can address loneliness and treatment disengagement. It involves periodically sending brief messages to at-risk individuals with nondemanding expressions of care and concern. It is one of just two non-pharmacologic interventions to have evidence in randomized controlled trials (RCTs) for reducing rates of suicide. However, Caring Contacts has only been evaluated in a relatively narrowly indicated population of patients with acute psychiatric issues.

Major gaps in the understanding of Caring Contacts include whether it reduces loneliness, whether it can diminish causes of mortality besides suicide, and whether it is effective older Veterans and patients with treatment disengagement. The overarching objective of this project is to evaluate "Crisis Caring Contacts" (CCC), an adaptation of Caring Contacts tailored to Veterans at risk for lack of social connection and lapses in treatment amidst the COVID-19 pandemic and its aftermath.

Primary aims for this study are: 1) Among older Veterans with poor treatment engagement, evaluate the effectiveness of Crisis Caring Contacts in decreasing loneliness, compared to enhanced usual care; 2) Evaluate the effect of Crisis Caring Contacts on other important outcomes, including treatment engagement and suicidal ideation; 3) Explore potential moderators of treatment response to Crisis Caring Contacts; and 4) Explore the effect of Crisis Caring Contacts on all-cause mortality, suicide attempts, and drug overdoses.

Impact: This project will advance scientific understanding of key gaps related to the mechanisms and outcomes of Caring Contacts, while also evaluating a timely, pragmatic, low-cost, and scalable intervention for Veterans affected by lack of social connection and treatment engagement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• no valid mailing address

• no valid phone number

• inclusion in an existing Caring Contacts program

• diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• Crisis Caring Contacts post cards
A series of post cards with Crisis Caring Contacts content sent over 10 months
• Control post cards
A series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Das A, Padala KP, Crawford CG, Teo A, Mendez DM, Phillips OA, Wright BC, House S, Padala PR. A systematic review of loneliness and social isolation scales used in epidemics and pandemics. Psychiatry Res. 2021 Dec;306:114217. doi: 10.1016/j.psychres.2021.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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. Visits will be required to be linked to a chronic psychiatric or medical diagnosis, and occur at one of the study sites to count. More visits will represent greater treatment engagement.	The 12-month period from the date of randomization to 12-month follow-up
Secondary	PROMIS Short Form v2.0 ? Emotional Support 4a	This scale has a range from 4 - 20, with higher scores representing greater perceived emotional support.	12-month follow-up
Secondary	Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)	Adapted to assess trust in the VA specifically, this scale has a score range from 3 - 15, with higher scores representing more trust.	12-month follow-up
Secondary	Depressive Symptom Index Suicidality Subscale (DSI-SS)	This scale has a score range from 0 - 12, with higher scores representing greater degrees of suicidality.	12-month follow-up
Secondary	Suicide Ideation Scale (SIS)	This scale has a score range from 10 - 50, with higher scores representing greater degrees of suicidality.	12-month follow-up