Loneliness and Health Outcomes in the High Need Population

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05484258
Collaborator
(none)
30
1
2
10.5
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Shared Medical Visit
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Loneliness and Health Outcomes in the High Need Population
Actual Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care

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

Active Comparator: Group Medical VIsits

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

Outcome Measures

Primary Outcome Measures

  1. Change in Loneliness from Baseline at 0 and at 3, 6 and 9 months. [0, 3, 6, and 9 months]

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

Secondary Outcome Measures

  1. Change in the number of ED visits, Inpatient, Observations [0, 3, 6 and 9 months]

    ED Visits and Hospital Utilization (Inpatient, Observation Admissions)

  2. Change in Depression from Baseline (0), and at 3, 6, and 9 months [0, 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

  3. 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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37203

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: FRANCIS S BALUCAN, Vanderbilt University Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Francis Balucan, Medical Director, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05484258
Other Study ID Numbers:
  • 220958
First Posted:
Aug 2, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francis Balucan, Medical Director, Vanderbilt University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022