Clinical trial NCT05089201: A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations
Official title: A Pilot Study to Examine the Impact of a Therapy Dog Intervention on Loneliness and Related Health Outcomes in Vulnerable Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Depression
Anxiety
Quality of Life
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Waltham Petcare Science Institute
name: Human Animal Bond Research Institute (HABRI)
First posted: 2021-10-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants enrolled
timeFrame: 2 years
measure: Attrition rate
timeFrame: 30 months
Secondary outcomes:
measure: Change in loneliness
timeFrame: Baseline to 6 months
measure: Change in depression
timeFrame: Baseline to 6 months
measure: Change in anxiety
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nancy R. Gee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Lisa Townsend, PhD
role: STUDY_DIRECTOR
References: