Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-29 @ 11:52 PM
Study NCT ID:
NCT05599659
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2022-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Calgary Movement Disorders Advanced Care Pilot Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The clinical trial is a prospective cohort study analysing the effect of palliative care interventions on quality of life, patient satisfaction, carepartner burden and health care utilization patterns in patients living with parkisonism and their carepartners.\n\nParticipants will:\n\n* Receive multidisciplinary palliative care.\n* Answer questions related to the quality of life, patient satisfaction, carepartner burden and health care utilization patterns.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in Quality of Life Alzheimer's Disease (QOL-AD)", 'timeFrame': 'Every 3 months for 2 years', 'description': "The QOL-AD is a 13-item questionnaire designed to provide both a patient and a caregiver report of the quality of life (QOL), it uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks."}, {'measure': 'Changes in 12-Item Zarit Burden Interview (ZBI-12)', 'timeFrame': 'Every 3 months for 2 years', 'description': 'ZBI-12 is validated as a screening tool for advanced illness. The ZBI-12 is rated on a 12 items scale, with the severity of burden using a range of responses from 0 to 4 points per item and a total score range of 0 to 48. Scoring 0-10 is considered as a no to mild burden; 10-20, a mild to moderate burden and \\>20, a high burden. It measures changes in physical, emotional, social, and financial problems that can be experienced by family caregivers.'}, {'measure': 'Changes in Health Care Utilization survey', 'timeFrame': 'Every 3 months for 2 years', 'description': 'We will perform a Health Service Utilization Survey to measure changes in the number of hospitalizations, emergency room visits, home health services, and nursing home placement.'}], 'secondaryOutcomes': [{'measure': "Changes in Edmonton Symptom Assessment Scale revised for Parkinson's Disease (ESAS-PD)", 'timeFrame': 'Every 3 months for 2 years', 'description': 'The ESAS is a comprehensive, yet brief and practical self-reporting tool of symptom severity (intensity) for nine common symptoms of advanced cancer (pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath), with the option of adding a tenth patient-specific symptom. It rates the severity of each symptom on a 0 to 10 scale, where 0 represents the absence (or best possible intensity) of the symptom and 10 represents the worst possible severity.'}, {'measure': 'Changes in the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT- Sp-12)', 'timeFrame': 'Every 3 months for 2 years', 'description': 'The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) is the most widely used measure of spiritual well-being among those with long-term illness. The FACIT-Sp comprises 12 statements, or items, each of which is rated on a 5-point scale by the respondent based on how true the item was during the past week, 0 for not at all, 1 for a little bit, 2 for somewhat, 3 for quite a bit and 5 for very much.'}, {'measure': 'Semi-structured Qualitative Interview to receive Patient and Care Partner recommendations', 'timeFrame': 'Every 3 months for 2 years', 'description': 'It will be performed on patients and care partners for optimizing the palliative care services provided and delivery methods.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative Care'], 'conditions': ["Parkinson's Disease and Parkinsonism"]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to analyse the effect of palliative care interventions on quality of life, patient satisfaction, carepartner burden and health care utilization patterns in patients living with parkisonism and their carepartners.\n\nParticipants will:\n\n* Receive multidisciplinary palliative care.\n* Answer questions related to the quality of life, patient satisfaction, carepartner burden and health care utilization patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who have a PD diagnosis or another PDRD diagnosis (multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or Lewy body dementia)\n* Participants who have moderate to high PC needs based on the Palliative Care Needs Assessment Tool (PC-NAT)\n* Participants who are between 20 and 100 years old\n\nExclusion Criteria:\n\n* Immediate and urgent palliative care needs. These patients will be offered appropriate services immediately\n* Participants who have other illnesses that could require PC e.g. metastatic cancer\n* Participants already receiving PC and/or hospice\n* Patients with a diagnosis of severe cognitive impairment (Montreal Cognitive Assessment \\<10). These patients will be offered appropriate services. Care partners can participate.'}, 'identificationModule': {'nctId': 'NCT05599659', 'acronym': 'ACT for PD', 'briefTitle': 'The Calgary Movement Disorders Advanced Care Pilot Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'The Calgary Movement Disorders Advanced Care Pilot Program', 'orgStudyIdInfo': {'id': 'REB22-0545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palliative care', 'description': 'Participants will receive palliative care.', 'interventionNames': ['Behavioral: Palliative care']}], 'interventions': [{'name': 'Palliative care', 'type': 'BEHAVIORAL', 'otherNames': ['Advanced care'], 'description': 'It is a pilot model of outpatient clinical care for patients in advanced stages of PDRD that will allow earlier access to PC in this population. PC visits will be in person or by telemedicine every three months and complemented with phone calls by different team members when needed as defined by the PC team.\n\nThe typical visit duration will be 2 to 2.5 hours and address nonmotor symptoms, goals of care, anticipatory guidance, difficult emotions, and carepartner support. Providers will communicate in-person or via notes during the clinic visit to increase interdisciplinary coordination and meet at the end of the day for discussion including follow-up plans.\n\nThe team will consist of a neurologist, a registered nurse with palliative care experience and training, a psychology counselor, a social worker, spiritual counselor and a research assistant.', 'armGroupLabels': ['Palliative care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Veronica Bruno, MD, MPH', 'role': 'CONTACT', 'email': 'veronica.bruno@ucalgary.ca', 'phone': '4032207875'}, {'name': 'Karla Cantu Flores, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Veronica Bruno, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Movement Disorder Program, Foothills Medical Center, Alberta Health Services', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Veronica Bruno, MD, MPH', 'role': 'CONTACT', 'email': 'veronica.bruno@ucalgary.ca', 'phone': '4039194262'}, {'name': 'Karla Cantu Flores, MD', 'role': 'CONTACT', 'email': 'karla.cantuflores1@ucalgary.ca', 'phone': '4032107542'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MPH', 'investigatorFullName': 'Veronica Bruno', 'investigatorAffiliation': 'University of Calgary'}}}}