A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05089201
Collaborator
Waltham Petcare Science Institute (Other), Human Animal Bond Research Institute (HABRI) (Other)
180
Enrollment
1
Location
3
Arms
27.5
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to test whether an animal-assisted interaction (AAI) intervention is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services. Participants will be patients admitted for an inpatient stay at Virginia Commonwealth University Health who meet the study entry requirements.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Animal-assisted interaction
  • Behavioral: Conversational control
N/A

Detailed Description

Participants will be randomly assigned (like the flip of a coin) to receive one of the following interventions:

  1. Animal-assisted interaction (a dog-handler team will visit them in their hospital room)

  2. Conversational interaction with just participants and the handler

  3. Treatment as usual (the regular services patients are currently receiving in the hospital)

Participation in this study will last six months. This includes the three days on which participants will receive one of the interventions described above, plus completing some questionnaires online or by phone one month and six months after the baseline visit. These questionnaires will ask questions about pet ownership, relationship with pets participants have had, loneliness, depression, anxiety, health-related quality of life, significant life events in the past year, and social supports. Approximately 180 individuals will participate in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Animal-assisted interaction (AAI)

Dogs and handlers will visit with patients for 20 minutes and discuss semi-scripted topics.

Behavioral: Animal-assisted interaction
A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay

Active Comparator: Conversational interaction

Handlers will have a 20 minute semi-scripted conversation with patients.

Behavioral: Conversational control
A handler alone will visit participants without a dog for approximately 20 minutes on 3 consecutive days during their inpatient hospital stay

No Intervention: Treatment as usual

Patients will receive treatment as usual.

Outcome Measures

Primary Outcome Measures

  1. Number of participants enrolled [2 years]

    The number of eligible patients who sigh consent forms and are randomized to a condition

  2. Attrition rate [30 months]

    Number of participants who do not complete the full study

Secondary Outcome Measures

  1. Change in loneliness [Baseline to 6 months]

    Loneliness will be assessed using the 20-item Revised (Version 3) University of California, Los Angeles Loneliness Scale (Rev University of California, Los Angeles - Loneliness Scale).

  2. Change in depression [Baseline to 6 months]

    Depressive symptomology will be measured with the 10-item Center for Epidemiological Studies Depression short form (CESD-10) scale.

  3. Change in anxiety [Baseline to 6 months]

    Anxiety will be measured using the 20-item scale of the State-Trait Anxiety Inventory for Adults (STAI-AD).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years of age or older

  • Projected to be admitted to the hospital for the upcoming four days

  • Speak English

  • Able to provide consent.

Exclusion Criteria:
  • Fear of, or allergy to, dogs

  • Documented contact precautions

  • Cognitive impairment that prevents consent or completion of measures.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Virginia Commonwealth UniversityRichmondVirginiaUnited States23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • Waltham Petcare Science Institute
  • Human Animal Bond Research Institute (HABRI)

Investigators

  • Principal Investigator: Nancy R. Gee, PhD, Virginia Commonwealth University
  • Study Director: Lisa Townsend, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT05089201
Other Study ID Numbers:
  • HM20021567
First Posted:
Oct 22, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021