Clinical trial

Clinical Trial of a Disinfectant Intervention in Therapy Dogs to Combat Hospital-associated Pathogens and Promote Sustainability of Animal-Assisted Visitation Programs

Name

R01HD097692

Description

Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.

Trial arms

Trial start

2023-05-01

Estimated PCD

2024-12-31

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Chlorhexidine

The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs

Arms:

CHX Intervention A, CHX Intervention B

Other names:

CHX

Size

412

Primary endpoint

Child MRSA exposure

Baseline through intervention completion, an average of 60 minutes

Eligibility criteria

Inclusion Criteria: * Children between the ages of 3 and 17 years * Cleared by physician to participate in a hospital-based animal-assisted visitation program session with any enrolled dog Exclusion Criteria: * Children who report sensitivity to chlorhexidine products * Children who report allergy to dogs or sensitivity to dog allergen

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multicenter, parallel-arm randomized controlled trial, with 1:1 allocation for intervention versus control. Among those randomized to intervention, dog-handler teams will be additionally randomized to Intervention A first, with crossover to Intervention B, or to Intervention B first, with crossover to Intervention A.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 412, 'type': 'ESTIMATED'}}

Updated at

2023-07-03

1 organization

Organization

Johns Hopkins Bloomberg School of Public Health