Heart FailureNCT00391456
Animal-Assisted Therapy for Hospitalized Heart Failure Patients
A study testing Animal-assisted Therapy in people with Heart Failure, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Animal-assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jul 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
- age between 18 and 80 years
- ability to read, write, and speak English
- mental status: alert and oriented to person, place, and time
- SVR greater than 1200 dyne · sec · cm-5 at least once within 12 hours from the start of data collection
Who cannot join
- SVR less than 1200 dyne · sec · cm-5
- allergies to dogs
- immunosuppression, defined as a white blood cell count of less than 4500 cells/mm3
- infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm3
- body temperature greater than 38ºC
- decreased level of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Animal-Assisted Therapy to Decrease Cardiopulmonary Pressures, Neurohormone Levels, and State Anxiety in Patients Hospitalized With Heart Failure
Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
The purpose of this study was to determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Read the detailed description
Context: Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
Objectives: To determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Design, Setting, Participants: A 3-group (volunteer-dog team, volunteer only, and control) randomized repeated-measures experimental design was used in 76 adult patients with advanced heart failure hospitalized between November 2001 and July 2004. Longitudinal analysis was used to model differences among the 3 groups at 3 time points.
Interventions: One group received a 12-minute visit from a volunteer with a therapy dog, another group received a 12-minute visit from a volunteer, and the control group received usual care, at rest. Data were collected at baseline, 8 minutes after the intervention started, and 16 minutes (4 minutes after intervention ended).
Main Outcome Measures: Blood pressure, heart rate, pulmonary artery pressure, pulmonary capillary wedge pressure, right atrial pressure, cardiac index, systemic vascular resistance, plasma levels of epinephrine and norepinephrine, and state anxiety.
Results: Compared with the control group, patients visited by a volunteer-dog team showed significantly greater decreases in pulmonary artery pressure during (5.34, P = .003) and after (5.78, P = .001) the intervention, pulmonary capillary wedge pressure during (3.09, P = .02) and after (4.31, P = .002) the intervention, and epinephrine (17.54, P = .04) and norepinephrine (240.14, P = .02) levels during the intervention. After the intervention, patients visited by the volunteer-dog team showed the greatest decrease in state anxiety over patients visited by a volunteer only (6.65, P = .003) and the control group (9.13, P < .0001).
Conclusions: Animal-assisted therapy improves cardiopulmonary pressures, neurohormone levels, and anxiety in patients hospitalized with heart failure.
- Conditions
- Heart Failure
- Being tested
- Animal-assisted Therapy
- Keywords
- animal-assisted therapy, dog hospital visit, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
heart rate
pulmonary artery pressure
pulmonary capillary wedge pressure
right atrial pressure
cardiac index
systemic vascular resistance
plasma levels of epinephrine
plasma levels of norepinephrine
state anxiety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startNov 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 76 participants
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Pet Care Trust
- Investigators
- Kathie Cole, RN, MSN, Principal investigator, University of California, Los AngelesAnna Gawlinski, RN, DNSc, Principal investigator, UCLA Medical Center & School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391456
- Sponsor's protocol ID
- #01061809
- Other IDs
- ISRCTN26749623
- Status last verified
- Jun 2016
- First submitted
- 23 Oct 2006
- Last updated
- 3 Jun 2016
- Results posted
- No
Publications
Cole K, Gawlinski A, Steers N. Animal assisted therapy decreases hemodynamics, plasma epinephrine and state anxiety in hospitalized heart failure patients. Circulation 112(17 Supplement II):527, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Animal-Assisted Therapy to Decrease Cardiopulmonary Pressures, Neurohormone Levels, and State Anxiety in Patients Hospitalized With Heart Failure
- ClinicalTrials.gov ID
- NCT00391456
- Acronym / sponsor ID
- #01061809
- Conditions
- Heart Failure
- Keywords
- animal-assisted therapy, dog hospital visit, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Pet Care Trust
- Study start
- Nov 2001
- Study completion
- Jul 2004
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
The purpose of this study was to determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Detailed description
Context: Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
Objectives: To determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Design, Setting, Participants: A 3-group (volunteer-dog team, volunteer only, and control) randomized repeated-measures experimental design was used in 76 adult patients with advanced heart failure hospitalized between November 2001 and July 2004. Longitudinal analysis was used to model differences among the 3 groups at 3 time points.
Interventions: One group received a 12-minute visit from a volunteer with a therapy dog, another group received a 12-minute visit from a volunteer, and the control group received usual care, at rest. Data were collected at baseline, 8 minutes after the intervention started, and 16 minutes (4 minutes after intervention ended).
Main Outcome Measures: Blood pressure, heart rate, pulmonary artery pressure, pulmonary capillary wedge pressure, right atrial pressure, cardiac index, systemic vascular resistance, plasma levels of epinephrine and norepinephrine, and state anxiety.
Results: Compared with the control group, patients visited by a volunteer-dog team showed significantly greater decreases in pulmonary artery pressure during (5.34, P = .003) and after (5.78, P = .001) the intervention, pulmonary capillary wedge pressure during (3.09, P = .02) and after (4.31, P = .002) the intervention, and epinephrine (17.54, P = .04) and norepinephrine (240.14, P = .02) levels during the intervention. After the intervention, patients visited by the volunteer-dog team showed the greatest decrease in state anxiety over patients visited by a volunteer only (6.65, P = .003) and the control group (9.13, P < .0001).
Conclusions: Animal-assisted therapy improves cardiopulmonary pressures, neurohormone levels, and anxiety in patients hospitalized with heart failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
- age between 18 and 80 years
- ability to read, write, and speak English
- mental status: alert and oriented to person, place, and time
- SVR greater than 1200 dyne · sec · cm-5 at least once within 12 hours from the start of data collection
Key exclusion criteria (6 listed)
- SVR less than 1200 dyne · sec · cm-5
- allergies to dogs
- immunosuppression, defined as a white blood cell count of less than 4500 cells/mm3
- infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm3
- body temperature greater than 38ºC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted Therapy | Behavioural | – |
Primary outcome
Blood pressure
heart rate
pulmonary artery pressure
pulmonary capillary wedge pressure
right atrial pressure
cardiac index
systemic vascular resistance
plasma levels of epinephrine
plasma levels of norepinephrine
state anxiety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Results publicationCole K, Gawlinski A, Steers N. Animal assisted therapy decreases hemodynamics, plasma epinephrine and state anxiety in hospitalized heart failure patients. Circulation 112(17 Supplement II):527, 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathie Cole, RN, MSN principal investigator
University of California, Los Angeles
Anna Gawlinski, RN, DNSc principal investigator
UCLA Medical Center & School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted Therapy in people with Heart Failure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure. The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.