Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 9:42 PM
Study NCT ID:
NCT02441868
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Family caregiver stress as measured by Salivary cortisol', 'timeFrame': 'Baseline and participants will be followed for an average of four weeks to end at time of death.', 'description': 'Salivary cortisol'}, {'measure': 'Family anxiety questionnaire', 'timeFrame': 'Baseline and participants will be followed for an average of four weeks to end at time of death', 'description': 'Promis anxiety Short form'}, {'measure': 'Family depression questionnaire', 'timeFrame': 'Baseline and participants will be followed for an average of four weeks to end at time of death'}], 'primaryOutcomes': [{'measure': 'Change in patient respiratory comfort', 'timeFrame': 'Baseline and up to four weeks until patient death', 'description': 'The Respiratory Distress Observation Scale will be used to measure patient respiratory comfort at enrollment (baseline), twice each week during the study until patient death.'}], 'secondaryOutcomes': [{'measure': 'Family caregiver burden index', 'timeFrame': 'Baseline and participants will be followed for an average of 4 weeks until date of death', 'description': 'The Modified Caregiver Strain Index'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyspnea']}, 'descriptionModule': {'briefSummary': 'This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.', 'detailedDescription': 'Shortness of breath is a prevalent symptom causing distress among patients at the end of life. In home hospice care family caregivers are expected to assist their family member with symptom management. This is often accomplished with little or no training.\n\nThe investigators have developed a bundle of training materials targeted for family caregivers of home hospice patients at risk for shortness of breath. The investigators will pilot test the intervention in this clinical trial. A future randomized clinical trial is planned and the evidence from this pilot will enhance the planning of that future trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, COPD, or heart failure.\n* Family caregiver in patient's home must speak and read English.\n\nExclusion Criteria:\n\n* Patients with bulbar ALS or quadriplegia."}, 'identificationModule': {'nctId': 'NCT02441868', 'briefTitle': 'Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care', 'orgStudyIdInfo': {'id': 'RDOS-Family'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'all participants will receive the training', 'interventionNames': ['Behavioral: Shortness of breath recognition and treatment']}], 'interventions': [{'name': 'Shortness of breath recognition and treatment', 'type': 'BEHAVIORAL', 'description': 'Hospice registered nurses will train family caregivers about how to recognize patient shortness of breath. This training will employ a guided learning tool the Respiratory Distress Observation Scale-Family. Training will be done with a DVD and return demonstration of the skills using the patient. In addition, the family will be taught the bundle of evidence-based interventions to treat shortness of breath.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Angela Hospice', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}], 'overallOfficials': [{'name': 'Margaret L. Campbell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Margaret Campbell', 'investigatorAffiliation': 'Wayne State University'}}}}