Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-28 @ 6:43 AM
Study NCT ID:
NCT00391456
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2006-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Animal-Assisted Therapy for Hospitalized Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056447', 'term': 'Animal Assisted Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2004-07'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2006-10-23', 'studyFirstSubmitQcDate': '2006-10-23', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure'}, {'measure': 'heart rate'}, {'measure': 'pulmonary artery pressure'}, {'measure': 'pulmonary capillary wedge pressure'}, {'measure': 'right atrial pressure'}, {'measure': 'cardiac index'}, {'measure': 'systemic vascular resistance'}, {'measure': 'plasma levels of epinephrine'}, {'measure': 'plasma levels of norepinephrine'}, {'measure': 'state anxiety'}]}, 'conditionsModule': {'keywords': ['animal-assisted therapy', 'dog hospital visit', 'heart failure'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nObjectives: 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.\n\nDesign, 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.\n\nInterventions: 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).\n\nMain 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.\n\nResults: 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).\n\nConclusions: Animal-assisted therapy improves cardiopulmonary pressures, neurohormone levels, and anxiety in patients hospitalized with heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter\n* age between 18 and 80 years\n* ability to read, write, and speak English\n* mental status: alert and oriented to person, place, and time\n* SVR greater than 1200 dyne · sec · cm-5 at least once within 12 hours from the start of data collection\n\nExclusion Criteria:\n\n* SVR less than 1200 dyne · sec · cm-5\n* allergies to dogs\n* immunosuppression, defined as a white blood cell count of less than 4500 cells/mm3\n* infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm3\n* body temperature greater than 38ºC\n* decreased level of consciousness'}, 'identificationModule': {'nctId': 'NCT00391456', 'briefTitle': 'Animal-Assisted Therapy for Hospitalized Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Use of Animal-Assisted Therapy to Decrease Cardiopulmonary Pressures, Neurohormone Levels, and State Anxiety in Patients Hospitalized With Heart Failure', 'orgStudyIdInfo': {'id': '#01061809'}, 'secondaryIdInfos': [{'id': 'ISRCTN26749623'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Animal-assisted Therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kathie Cole, RN, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Anna Gawlinski, RN, DNSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Medical Center & School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pet Care Trust', 'class': 'OTHER'}]}}}