Loneliness and Health Outcomes in the High Need Population

NCT05484258 | Completed

• 1 other identifier: 220958
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The high need population are patients who have three or more chronic diseases and have a functional limitation in their ability to take care for themselves. Investigators aim to understand the effects of a support group intervention, with the use of group medical visits and understand longitudinal effects in emotional wellbeing and loneliness.

Conditions

Anxiety; Loneliness; Depression; Alcohol Use Disorder; Utilization, Health Care

Keywords

high need population; shared medical visits; social determinants of health

Outcome Measures

Primary Outcomes (1)

• Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.

  Using the Validated De Jong Giervald Loneliness Scale, scored from 0 (not lonely) to 11 (severely lonely),

  0, 3, 6, and 9 months

Secondary Outcomes (3)

• Change in the number of ED visits, Inpatient, Observations

  0, 3, 6 and 9 months

• Change in Depression from Baseline (0), and at 3, 6, and 9 months

  0, 3,6, and 9 months

• Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months

  0,3,6, and 9 months

Study Arms (2)

Standard Care

NO INTERVENTION

On baseline screen, would be screened for depression, alcohol use, and loneliness. Loneliness screen will be checked every 3 months.

Group Medical VIsits

ACTIVE COMPARATOR

For this arm, patients will have three visits of a shared medical visit, wherein a physician/APP will partner with a social worker to give a discussion about topics relevant to the high need population, including managing multiple medications, managing stress, and also palliative care.

Behavioral: Shared Medical Visit

Interventions

Shared Medical Visit BEHAVIORAL

Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.

Group Medical VIsits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are enrolled into the VIC program. These are patients that are 18 years old and above, and have either
• HCC Score 3.0 and above
• HCC 2.0 - 3.0 and 2 or more unplanned admissions in last 12 months
• HCC 0.24 - 0.35 + ESRD OR
• Charlson Score \>3, or LACE \>30

You may not qualify if:

• None

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Alcoholism; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Treatment Adherence and Compliance; Health Behavior

Study Officials

• FRANCIS S BALUCAN

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: August 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 1, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: July 2023 available for 1 year

Locations

US (1)