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Loneliness and Health Outcomes in the High Need Population

Loneliness and Health Outcomes in the High Need Population

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05484258
Enrollment
23
Registered
2022-08-02
Start date
2022-08-15
Completion date
2023-09-01
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

The high need population with functional limitations are patients who have three or more chronic diseases and have a functional limitation in their ability to care for themselves (such as bathing or dressing) or perform routine daily tasks. Two-thirds of the population is female, and three-quarters of them are white non-Hispanic and half of the population were described as low income. The High Need Population with functional limitations also utilizes the emergency department at twice the rate of adults with multiple chronic diseases and more than three times more likely to be hospitalized than adults of other populations. Loneliness is seen as a significant independent risk factor for poor health behaviors, physical health problems and psychiatric conditions. Loneliness and isolation are becoming a more recognized entity that contributes to worsening depression. Investigators aim to compare the of effects of a Social Worker and Physician/APP-led support group intervention on loneliness at 9 months, after up to 3 group visits. Shared Medical Visits as a form of support Group increase clinician-patient contact time and provide patients with support and prevention of chronic conditions increasing patient empowerment.

Interventions

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

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months.0, 3, 6, and 9 monthsUsing the Validated De Jong Giervald Loneliness Scale, scored from 0 (not lonely) to 11 (severely lonely),

Secondary

MeasureTime frameDescription
Change in the number of ED visits, Inpatient, Observations0, 3, 6 and 9 monthsED Visits and Hospital Utilization (Inpatient, Observation Admissions)
Change in Depression from Baseline (0), and at 3, 6, and 9 months0, 3,6, and 9 monthsWill be using PHQ 9 to evaluate depression in the population, 0-4 points equals normal or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months0,3,6, and 9 monthshe AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026