Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00391456
Protocol/serial number
Grant number: 01061809
Study information
Scientific title
Acronym
AAT
Study hypothesis
To determine whether a 12-minute hospital visit with a therapy dog improves haemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalised with heart failure.
Ethics approval
University of California and Los Angeles Institutional Review Board (UCLA IRB) approved November 2001.
Study design
A three group, randomised, repeated-measures experimental design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Heart failure
Intervention
Group one: 12-minute visit from a volunteer with a therapy dog
Group two: 12-minute visit from a volunteer
Group three: control group, received usual care
Data were collected at baseline, eight minutes after the intervention started, and 16 minutes (four minutes after intervention ended).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Haemodynamics
2. Neurohormonal levels
3. State anxiety
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2001
Overall trial end date
31/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
2. Age between 18 and 80 years
3. Ability to read, write, and speak English
4. Orientation status of alert and oriented to person, place, and time
5. Systemic Vascular Resistance (SVR) greater than 1200 dyne/sec/cm^-5 at least once within 12 hours from the start of data collection
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
76
Participant exclusion criteria
1. SVR less than 1200 dyne/sec/cm^-5
2. Allergies to dogs
3. Immunosuppression, defined as a white blood cell count of less than 4500 cells/mm^3
4. Infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm^3
5. Body temperature greater than 38 degrees Celsius
6. Decreased level of consciousness
Recruitment start date
01/11/2001
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United States of America
Trial participating centre
UCLA School of Nursing
Los Angeles
90095
United States of America
Funders
Funder type
Charity
Funder name
Pet Care Trust Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17962502
Publication citations
-
Results
Cole KM, Gawlinski A, Steers N, Kotlerman J, Animal-assisted therapy in patients hospitalized with heart failure., Am. J. Crit. Care, 2007, 16, 6, 575-85; quiz 586; discussion 587-8.