Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01419418
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2011-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' perspective of the factors that affects their decisions regarding management of their PAD", 'timeFrame': '1 year', 'description': 'Qualitative interview that will collect patients perspectives and will be analyzed for thoughts, opinions, feelings, and concepts.'}], 'secondaryOutcomes': [{'measure': "Quantitative Morinsky's Medication adherence survey", 'timeFrame': '1 year', 'description': "Morinsky's Medication adherence survey will be administered at baseline and one year to assess self report medication adherence."}, {'measure': 'Quantitative PAQ health status survey', 'timeFrame': '1 year', 'description': 'PAQ health status will be administered at the initial visit as well as the last one-on-one interview to assess disease specific health status.'}, {'measure': 'Quantitative EQ-5D health status survey', 'timeFrame': '1 year', 'description': 'survey will be administered at the initial visit as well as the last one-on-one interview to assess overall health status.'}, {'measure': 'Quantitative Stage of Change Survey', 'timeFrame': '1 year', 'description': 'Stage of Change motivational survey will be administered at the initial visit as well as the last one-on-one interview to assess patients motivational status.'}, {'measure': 'Quantitative SEAMS survey', 'timeFrame': '1 year', 'description': 'SEAMS self efficacy survey will be administered at the initial visit as well as the last one-on-one interview to assess patient self efficacy to adhere to medication treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peripheral Arterial Disease (PAD)', 'Qualitative analysis', "Patients' perspective"], 'conditions': ['Peripheral Arterial Diseases']}, 'descriptionModule': {'briefSummary': "Specific Aims: To delve into the complex phenomena of living with Peripheral Arterial Disease (PAD), and to investigate the patients' perspective of the factors that affects their decisions regarding management of their PAD.\n\na) Utilize a qualitative approach to uncover factors that patients perceive support the management of their condition utilizing a purposive sampling of Peripheral Arterial Disease patients.\n\n1. To determine what they believe to be effective tools to support themselves to improve their condition.\n2. To determine from the patient's perspective if adherence to prescribed medical regimes are important for them to improve their PAD outcomes.\n3. To describe the patient factors of those who are self reported adherent compared to those who are not or unable to their prescribed regimen.", 'detailedDescription': 'Cardiovascular Diseases (CVD) affects as many lives each year as cancer, chronic lower respiratory diseases, accidents and diabetes mellitus combined. One in three American adults (about 80,000,000) has one or more types of cardiovascular disease. Prevention and management of CVD is a public health goal, yet, it remains a major challenge. Even hypertension, which is easily detected and usually controllable, has only a 50 percent control rate.\n\nPeripheral Arterial Disease (PAD) is one type of CVD, which affects about eight million Americans and is also associated with significant morbidity and mortality. PAD increases with age and disproportionately affects African Americans. Interestingly, despite its prevalence and cardiovascular risk implications, only 20 to 30 percent of PAD patients are undergoing treatment.\n\nMedical management of these diseases has substantially contributed to improved morbidity and mortality. However, for the medical therapies to be successful the patients need to take their medications and adjust their lifestyles, as prescribed. Overall, "typical adherence rates for the general population are about 50 percent for medications and are much lower for lifestyle prescriptions and other more behaviorally demanding regimens". Few studies have investigated the reactions and thoughts regarding the efficacy of therapies/interventions from the perspective of the participants. Meta analyses on adherence have also revealed that the patients\' perspectives are often absent and that present adherence theories are more successful in explaining non-adherence than improving adherence. Therefore, it is important to understand, from the perspective of the patient; the factors they believe improve their cardiac outcomes with an emphasis on the adherence to prescribed therapies.\n\nThis qualitative study will investigate the question: What are patients\' perspectives of factors that support the management of their cardiovascular condition to improve outcomes in a Peripheral Arterial Disease population? Cardiac outcomes of interest are health status defined by symptom burden, functional status, and health related quality of life, patients\' perception of the quality of care that they receive, and the experience of living with PAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "A purposive sampling technique, meaning the sample will be selected according to the participant's diagnosis of the specific disease, will be utilized to enroll up to 24 Peripheral Arterial Disease patients from the VA Peripheral Arterial Disease clinic.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of Peripheral Arterial Disease\n\nExclusion Criteria:\n\nUnable to converse about the topic under investigation for up to one hour for multiple visits\n\nPregnancy'}, 'identificationModule': {'nctId': 'NCT01419418', 'briefTitle': "Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes", 'organization': {'class': 'FED', 'fullName': 'VA Eastern Colorado Health Care System'}, 'officialTitle': "A Study of Patients' Perspectives of Factors That Support the Management of Cardiac Care for Improved Outcomes in a Peripheral Arterial Disease Population", 'orgStudyIdInfo': {'id': '10-1361'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peripheral Arterial Disease (PAD)', 'description': 'This is a longitudinal observational study. There were no interventions administered.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA ECHCS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Anne C Lambert-Kerzner, PhD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VAMC in Denver, Co.'}, {'name': 'Thomas Tsai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VAMC Denver, Co.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Eastern Colorado Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Health Services Researcher', 'investigatorFullName': 'Anne Lambert-Kerzner', 'investigatorAffiliation': 'VA Eastern Colorado Health Care System'}}}}