Loneliness and Health Outcomes in the High Need Population

Depression Clinical Trial

Official title:

Loneliness and Health Outcomes in the High Need Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05484258
• Other study ID #: 220958
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Shared Medical Visit
Group visit wherein physician and Social Worker, would be discussing topics relevant to the population.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the number of ED visits, Inpatient, Observations	ED Visits and Hospital Utilization (Inpatient, Observation Admissions)	0, 3, 6 and 9 months
Secondary	Change in Depression from Baseline (0), and at 3, 6, and 9 months	Will 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	0, 3,6, and 9 months
Secondary	Change in Active alcohol use disorders (including alcohol abuse or dependence) from Baseline (0), and at 3, 6, and 9 months	he 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.	0,3,6, and 9 months