Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT04686266
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020774', 'term': 'Pick Disease of the Brain'}], 'ancestors': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lmassimo@upenn.edu', 'phone': '215-349-5863', 'title': 'Lauren Massimo, PhD, CRNP', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'As this was a pilot study, it was not sufficiently powered to observe effects on all dimensions of the Self-Care Inventory or our secondary outcome measures. Our caregivers had a high level of education, which is related to socioeconomic status, and it will be important for future studies to examine other social determinants of health and how that affects self-care.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Self-Care Inventory (SCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'SCI Maintenance Baseline', 'categories': [{'measurements': [{'value': '71.4', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'SCI Maintenance Month 6', 'categories': [{'measurements': [{'value': '80.4', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '68.9', 'spread': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'SCI Management Baseline', 'categories': [{'measurements': [{'value': '54.6', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'SCI Management Month 6', 'categories': [{'measurements': [{'value': '70.7', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '26.9', 'groupId': 'OG001'}]}]}, {'title': 'SCI Monitoring Baseline', 'categories': [{'measurements': [{'value': '60.5', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '64.6', 'spread': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'SCI Monitoring Month 6', 'categories': [{'measurements': [{'value': '77.8', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '24.4', 'groupId': 'OG001'}]}]}, {'title': 'SCI Confidence Baseline', 'categories': [{'measurements': [{'value': '66.3', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '22.3', 'groupId': 'OG001'}]}]}, {'title': 'SCI Confidence Month 6', 'categories': [{'measurements': [{'value': '79.6', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '23.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': '30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Q1- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Q1- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Q2- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Q2- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Q3- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Q3- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Q4- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Q4- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Q5- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Q5- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Q6- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Q6- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Q7- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Q7- Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of "never" (0) to "all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'skipped question by participant'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.1', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '23.4', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The Perceived Stress Scale is a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.7', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '15.3', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'CES-D is a valid and reliable scale for detecting caregiver depression in dementia. The scoring is on a likert scale 0: Rarely or none of the time (less than 1 day), 1: Some or a little of the time (1-2 days), 2: Occasionally or a moderate amount of time (3-4 days), and 3: Most or all of the time (5-7 days). Higher scores represent greater depressive symptoms. Total scores can range 0 to 60. A score equal or above a 16 means a person is at risk for clinical depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ways of Coping Questionnaire, Short Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.7', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '15.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '23.4', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Zarit Burden Interview (ZBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38.4', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '39.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '12.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The ZBI has been used in numerous informal dementia caregiver studies to capture burden associated with providing care to a loved one. Total scores are summed and a range is provided for little to no burden (0-21) to severe burden (61-88).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'OG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.4', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '14.6', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Commonly used scale to evaluate 12 common behaviors in dementia including Delusions, Hallucinations, Agitation/Aggression, Depression, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability, Aberrant motor behavior, Sleep and Nighttime Behavior Disorders, Appetite and Eating Disorders. Ratings include the frequency of the occurrence of behaviors (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and the level of severity of behaviors (1 = mild, 2 = moderate, 3 = severe). The behavioral domain total score is the product of the frequency score multiplied by the severity score for that behavior. The NPI total score is the sum of all the individual behavioral domains. Scores range from 0-144. Higher scores demonstrate greater symptoms frequency and severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'FG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Month 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Month 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Month 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited by clinician referral from the University of Pennsylvania Frontotemporal Degeneration Center between December 2020 to April 2021. The first participant was enrolled in December 2020 and the final was enrolled in April 2021. Data collection began in December 2020 and finished in November 2021.', 'preAssignmentDetails': 'Of 43 people contacted for recruitment, 8 declined to participate and 4 were ineligible. 31 were randomized to the protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time\n\nHealth Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research'}, {'id': 'BG001', 'title': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.80', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '65.07', 'spread': '9.95', 'groupId': 'BG001'}, {'value': '63.93', 'spread': '10.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race of Caregiver', 'categories': [{'title': 'Black or AA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White or Caucasian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Multi-Racial', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education of Caregiver (years)', 'classes': [{'categories': [{'title': 'Grade School', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'High School graduate or GED', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Trade School or some college', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': "Bachelor's Degree", 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Doctoral or Professional Degree', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relationship to Patient', 'classes': [{'categories': [{'title': 'Daughter', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Mother', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Spouse', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Other Relative', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time as Caregiver (years)', 'classes': [{'categories': [{'measurements': [{'value': '4.97', 'spread': '2.26', 'groupId': 'BG000'}, {'value': '4.99', 'spread': '3.26', 'groupId': 'BG001'}, {'value': '4.98', 'spread': '2.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Dementia Rating Scale-Frontotemporal Lobar Degeneration (global score)', 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '1.70', 'spread': '0.75', 'groupId': 'BG001'}, {'value': '1.77', 'spread': '0.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinical Dementia Rating Scale-Frontotemporal Lobar Degeneration (CDR-FTLD) is used to characterize several cognitive and functional aspects of dementia including Memory, Orientation, Judgment \\& Problem Solving, Community Affairs, Home \\& Hobbies, and Personal Care as well as two additional domains, behavior and language. Each section is scored on a scale of 0 to 3 (0 = normal, 0.5 = very mild dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia). The CDR global score is a weighted algorithm to determine the average score to represent overall impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One participant in the Health Information group dropped out at Month 1 and therefore, was removed from all analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-25', 'size': 283912, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-31T10:20', 'hasProtocol': True}, {'date': '2020-09-08', 'size': 239986, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-10-31T10:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The Health Coaches providing the intervention and the caregiver participants will not be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2020-12-22', 'resultsFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-02', 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Self-Care Inventory (SCI)', 'timeFrame': '6 months', 'description': '30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.'}, {'measure': 'Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)', 'timeFrame': '6 months', 'description': 'The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of "never" (0) to "all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Perceived Stress Scale', 'timeFrame': '6 months', 'description': "The Perceived Stress Scale is a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress."}, {'measure': 'Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '6 months', 'description': 'CES-D is a valid and reliable scale for detecting caregiver depression in dementia. The scoring is on a likert scale 0: Rarely or none of the time (less than 1 day), 1: Some or a little of the time (1-2 days), 2: Occasionally or a moderate amount of time (3-4 days), and 3: Most or all of the time (5-7 days). Higher scores represent greater depressive symptoms. Total scores can range 0 to 60. A score equal or above a 16 means a person is at risk for clinical depression.'}, {'measure': 'Change From Baseline in Ways of Coping Questionnaire, Short Form', 'timeFrame': '6 months', 'description': 'This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers.'}, {'measure': 'Change From Baseline in Zarit Burden Interview (ZBI)', 'timeFrame': '6 months', 'description': 'The ZBI has been used in numerous informal dementia caregiver studies to capture burden associated with providing care to a loved one. Total scores are summed and a range is provided for little to no burden (0-21) to severe burden (61-88).'}, {'measure': 'Change From Baseline in Neuropsychiatric Inventory', 'timeFrame': '6 months', 'description': 'Commonly used scale to evaluate 12 common behaviors in dementia including Delusions, Hallucinations, Agitation/Aggression, Depression, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability, Aberrant motor behavior, Sleep and Nighttime Behavior Disorders, Appetite and Eating Disorders. Ratings include the frequency of the occurrence of behaviors (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and the level of severity of behaviors (1 = mild, 2 = moderate, 3 = severe). The behavioral domain total score is the product of the frequency score multiplied by the severity score for that behavior. The NPI total score is the sum of all the individual behavioral domains. Scores range from 0-144. Higher scores demonstrate greater symptoms frequency and severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavioral Variant of Frontotemporal Dementia', 'Caregiver Stress Syndrome']}, 'descriptionModule': {'briefSummary': 'The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.', 'detailedDescription': 'Informal caregivers of persons with Frontotemporal degeneration (FTD) are an understudied population with unique needs. FTD is a common cause of young-onset dementia with no known cure. Behavioral variant FTD (bvFTD) is the most common of the FTD syndromes and involves a progressive disorder of emotional regulation and personality, and significant impairment in executive function. bvFTD caregivers face unique challenges which are particularly stressful, including young age at which the disorder appears, behavioral symptoms like apathy and disinhibition that are severe and appear early in bvFTD, and the lack of appropriate supportive services. Indeed, numerous studies have demonstrated that stress, depression and burden are higher in FTD caregivers than in any of the other ADRDs, yet caregiver interventions tested in specifically in the FTD population have been limited to a few small studies that focus on education around patient behavior management, not caregiver self-care.\n\nThe research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.\n\n30 caregivers will be randomized 1:1 to a health information: health information + health coaching group. Catered information will be delivered via tablets over 6 months with testing dispersed at baseline, 1 month, 3 months, and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informal caregiver providing care at least 8 hours/week\n* Reporting poor self-care on screening (Health Self-Care Neglect Scale, score ≥ 2)\n* Able to complete the protocol, e.g., adequate vision and hearing, English speaking\n* Caregiver of a patient diagnosed bvFTD\n\nExclusion Criteria:\n\n* Participation in another support randomized, controlled trial\n* Untreated major psychiatric illness (Use of anti-anxiety/anti-depressant medicines is acceptable and will be adjusted in analysis if group imbalance is identified.)\n* Caregiver with Cognitive Impairment based on Telephone Interview for Cognitive Status (TICS) score \\<25'}, 'identificationModule': {'nctId': 'NCT04686266', 'acronym': 'ViCCY', 'briefTitle': 'Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Efficacy of a Virtual Intervention for Informal Caregivers of Adults With Frontotemporal Dementia', 'orgStudyIdInfo': {'id': '843660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ViCCY: Health Information + Health Coaching', 'description': 'This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time', 'interventionNames': ['Behavioral: Health Information + Health Coaching']}, {'type': 'NO_INTERVENTION', 'label': 'Health Information', 'description': 'Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites'}], 'interventions': [{'name': 'Health Information + Health Coaching', 'type': 'BEHAVIORAL', 'otherNames': ['ViCCY'], 'description': 'Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research', 'armGroupLabels': ['ViCCY: Health Information + Health Coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania, School of Nursing', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting 6 months after publication of our major trial data, we will share data with Penn trainees', 'ipdSharing': 'YES', 'description': 'Plan to share the data internally with doctoral students and post-doctoral trainees instead of sharing the data widely with external sources. Internal sharing will allow our trainees to complete meaningful studies using secondary analysis techniques and to finish their programs in a timely fashion.', 'accessCriteria': 'The Principal Investigator will personally review requests from students for use of the data. She will approve requests based on the importance of the questions asked. She will personally oversee progress in analysis and the publication of abstracts and articles based on the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}