Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-04-17 @ 5:27 AM
Study NCT ID:
NCT05849259
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'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'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'csritchie@mgh.harvard.edu', 'phone': '415-672-1780', 'title': 'Dr. Christine S Ritchie', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from baseline to the end of data collection, over 6 months.', 'description': 'The definition of an adverse event or serious adverse event do not differ from the CT.gov definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Dementia Care Quality at Home Caregivers', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dementia Care Quality at Home Practice Personnel', 'description': 'Practice personnel implementing the Dementia Care Quality at Home Intervention', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'The percentage of identified caregivers who complete baseline assessments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility for the Caregiver to Access Educational Materials and Community Resources.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention (6 months)', 'description': 'Percent of caregivers will report using 1 or more materials provided by the practice.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Feasibility for the Practice of Identifying Potential Patients/Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '% of practice staff that "agree" or "strongly agree" that "it was easy for our practice to generate a list of persons living with dementia"'}, {'type': 'PRIMARY', 'title': 'Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '% of practice staff that "agree" or "strongly agree" that "it was easy for our practice to generate a list of persons living with dementia"'}, {'type': 'PRIMARY', 'title': 'Feasibility for the Practice to Use Baseline Assessments.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention (6 months)', 'description': 'Percent of practice personnel who conduct assessments that rate assessments as feasible to use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '\\> 75% practice personnel who conduct assessments will "agree" or "strongly agree" that assessments were feasible to use'}, {'type': 'PRIMARY', 'title': 'Feasibility for the Practice to Complete Baseline Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'assessments', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The percent of audited assessments that are completed.', 'unitOfMeasure': 'assessments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'assessments', 'denomUnitsSelected': 'assessments', 'populationDescription': '75% of audited assessments will be completed'}, {'type': 'SECONDARY', 'title': 'Feasibility for the Practice of Recruiting Patient/Caregiver Dyads', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-intervention', 'description': 'Percentage of eligible dyads who enroll.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is greater than 50 as 80 is the number of dyads that were eligible for the study'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'title': 'QoL-AD Pre-Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': '26.8'}]}]}, {'title': 'QoL-AD Post-Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '30.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Intervention (baseline) and post-intervention (6 months)', 'description': "Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Quality of Life in Alzheimer's Disease score Pre and Post-Intervention"}, {'type': 'SECONDARY', 'title': 'Heard and Understood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post Intervention (6 months)', 'description': 'A one-item measure of caregivers who report that they felt heard and understood by the practice.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '% of caregivers who report that they felt heard and understood "quite a bit" or "completely" by the practice'}, {'type': 'SECONDARY', 'title': 'Caregivers - Net Promoter Score of Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '9.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The single question - "How likely are you to recommend X to a friend \\[or colleague\\]?" is rated from 0 - Not at all likely to 10 - Extremely likely.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility for the Practice to Use Care Modules.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '\\> 75% practice personnel who complete the modules will rate the modules as "feasible" or "very feasible" to use \\> 50% of audited modules will be completed'}, {'type': 'SECONDARY', 'title': 'Feasibility for the Practice to Complete Care Modules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'modules', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Post Intervention (6-months)', 'description': 'Percent of audited modules that are completed.', 'unitOfMeasure': 'modules', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'modules', 'denomUnitsSelected': 'modules', 'populationDescription': '\\> 50% of audited modules will be completed'}, {'type': 'SECONDARY', 'title': 'Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}, {'units': 'case conferences attended', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Practice personnel across two sites implementing the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Post-intervention (6 months)', 'description': '% of case conferences conducted with at least one staff member present from each site', 'unitOfMeasure': 'case conferences attended', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'case conferences attended', 'denomUnitsSelected': 'case conferences attended'}, {'type': 'SECONDARY', 'title': 'Acceptability of the Intervention to Caregivers to Participate in the Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-intervention (baseline)', 'description': 'Percent of caregivers invited to participate who agree to participate in the intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is greater than 50, as 80 is the number of dyads that were eligible for the study and invited to participate, 50 out of 80 enrolled.'}, {'type': 'SECONDARY', 'title': 'Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-intervention (baseline)', 'description': 'Percentage of eligible dyads who enroll who are racial and ethnic minorities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '50 caregivers received the Dementia Care Quality at Home Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'Caregivers Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'Practice Personnel Enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Role of Caregiver', 'classes': [{'categories': [{'title': 'Adult Child', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Facility Caregiver', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Spouse/Partner', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Niece', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Private Paid Caregiver', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Sibling', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hours Spent Caregiving per week', 'classes': [{'categories': [{'measurements': [{'value': '88', 'spread': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'hours per week', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Quality of Life in Alzheimer's Disease", 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Quality of Life in Alzheimer's Disease (QoL-AD) questionnaire is scored by summing responses to its 13 items, each rated on a 4-point Likert scale from 1 (poor) to 4 (excellent), to yield a total score between 13 and 52. Higher scores reflect better perceived quality of life. The total score can be interpreted across the continuum of quality of life, with lower scores indicating poorer quality of life and higher scores indicating better quality of life.\n\nThis measure is a caregiver reported measure on behalf of their care recipient living with dementia", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The Neuropsychiatric Inventory Questionnaire: Severity Score', 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Neuropsychiatric Inventory Questionnaire (NPI-Q) severity score is calculated by summing responses to its 12 items, each rated on a 3-point scale from 1 (mild) to 3 (severe), to yield a total score between 0 and 36. Higher scores indicate greater severity of neuropsychiatric symptoms. The total score reflects the overall burden of symptom severity, with lower scores indicating minimal or absent symptoms and higher scores reflecting more severe symptomatology.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'The Neuropsychiatric Inventory Questionnaire: Distress Score', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score is calculated by summing caregiver ratings of the distress caused by each of the 12 symptoms, scored on a 6-point scale from 0 (not at all distressing) to 5 (extremely distressing), to yield a total score between 0 and 60. Higher scores indicate greater caregiver distress associated with patients' neuropsychiatric symptoms. The total score reflects the overall emotional and psychological burden on caregivers, with lower scores suggesting minimal distress and higher scores indicating more severe caregiver distress.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Zarit Burden Interview Score', 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Zarit Burden Interview (ZBI) is scored by summing responses to its 22 items on a 5-point Likert scale, from 0 (not at all) to 4 (nearly always), to yield a total score between 0 and 88, with higher scores indicating greater caregiver burden. The total score is then interpreted within defined ranges: 0-21 for little or no burden, 21-40 for mild to moderate burden, 41-60 for moderate to severe burden, and 61-88 for severe burden.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Health Questionnaire 8 Item Score', 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Patient Health Questionnaire-8 (PHQ-8) is scored by summing responses to its 8 items, each rated on a 4-point scale from 0 (not at all) to 3 (nearly every day), to yield a total score between 0 and 24. Higher scores indicate greater depressive symptom severity. The total score is typically interpreted within defined ranges: 0-4 for none or minimal depression, 5-9 for mild depression, 10-14 for moderate depression, 15-19 for moderately severe depression, and 20-24 for severe depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Care Ecosystem Caregiver Self-Efficacy Score', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Caregivers rate their self-efficacy on a 5-point scale of whether they strongly agree, agree, neutral, disagree, or strongly disagree to 4 items. (minimum score of 4, maximum score of 20, with higher score indicating higher self-efficacy)\n\nI know where to get the services I need.\n\nI have people I can turn to when I need help with my problems.\n\nI feel confident that I can manage future caregiving challenges.\n\nI feel confident that I can manage (name of the person with dementia)'s changes in behavior.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Only the caregivers people living with dementia were enrolled in the study. The baseline data just reflects that of the caregiver or their reported measure of their care recipient living with dementia.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-16', 'size': 222508, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-13T13:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2023-04-07', 'resultsFirstSubmitDate': '2025-06-14', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-23', 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.', 'timeFrame': 'Baseline', 'description': 'The percentage of identified caregivers who complete baseline assessments.'}, {'measure': 'Feasibility for the Caregiver to Access Educational Materials and Community Resources.', 'timeFrame': 'Post-intervention (6 months)', 'description': 'Percent of caregivers will report using 1 or more materials provided by the practice.'}, {'measure': 'Feasibility for the Practice of Identifying Potential Patients/Caregivers', 'timeFrame': 'Baseline', 'description': 'Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice'}, {'measure': 'Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.', 'timeFrame': 'Baseline', 'description': 'Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).'}, {'measure': 'Feasibility for the Practice to Use Baseline Assessments.', 'timeFrame': 'Post-intervention (6 months)', 'description': 'Percent of practice personnel who conduct assessments that rate assessments as feasible to use'}, {'measure': 'Feasibility for the Practice to Complete Baseline Assessments', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The percent of audited assessments that are completed.'}], 'secondaryOutcomes': [{'measure': 'Feasibility for the Practice of Recruiting Patient/Caregiver Dyads', 'timeFrame': 'Pre-intervention', 'description': 'Percentage of eligible dyads who enroll.'}, {'measure': 'Patient Quality of Life', 'timeFrame': 'Pre-Intervention (baseline) and post-intervention (6 months)', 'description': "Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL."}, {'measure': 'Heard and Understood', 'timeFrame': 'Post Intervention (6 months)', 'description': 'A one-item measure of caregivers who report that they felt heard and understood by the practice.'}, {'measure': 'Caregivers - Net Promoter Score of Intervention', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The single question - "How likely are you to recommend X to a friend \\[or colleague\\]?" is rated from 0 - Not at all likely to 10 - Extremely likely.'}, {'measure': 'Feasibility for the Practice to Use Care Modules.', 'timeFrame': 'Post-intervention (6 months)', 'description': 'The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use'}, {'measure': 'Feasibility for the Practice to Complete Care Modules', 'timeFrame': 'Post Intervention (6-months)', 'description': 'Percent of audited modules that are completed.'}, {'measure': 'Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.', 'timeFrame': 'Post-intervention (6 months)', 'description': '% of case conferences conducted with at least one staff member present from each site'}, {'measure': 'Acceptability of the Intervention to Caregivers to Participate in the Intervention.', 'timeFrame': 'Pre-intervention (baseline)', 'description': 'Percent of caregivers invited to participate who agree to participate in the intervention.'}, {'measure': 'Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.', 'timeFrame': 'Pre-intervention (baseline)', 'description': 'Percentage of eligible dyads who enroll who are racial and ethnic minorities.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Quality of Life', 'Caregiver Stress']}, 'referencesModule': {'references': [{'pmid': '35351444', 'type': 'BACKGROUND', 'citation': 'Leff B, Ritchie C, Freeland DG, Jamshed N, Major A, Gallopyn N, Sharieff S, Taylor J, Yudin JA, Sheehan OC. 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Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.'}, {'pmid': '20957426', 'type': 'BACKGROUND', 'citation': 'Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.'}, {'type': 'BACKGROUND', 'citation': 'Krueger, RA, Casey MA. Focus groups: a practical guide for applied research. Thousand Oaks, CA: SAGE Publications, Inc.; 2000.'}, {'type': 'BACKGROUND', 'citation': 'Summit virtual meeting series: 2020 national research summit on care, services, and supports for persons with dementia and their caregivers. [Internet]. National Institute on Aging. 2020 [cited 2022 Apr 25]; Available from: https://www.nia.nih.gov/2020-dementia-care-summit'}, {'type': 'BACKGROUND', 'citation': 'Medical care at home comes of age. [Internet]. California Health Care Foundation. 2021[cited 2022 Apr 25]; Available from: https://www.chcf.org/publication/medical-care-home-comes-age/'}, {'pmid': '36465493', 'type': 'BACKGROUND', 'citation': 'Lucero KS. Net Promoter Score (NPS): What Does Net Promoter Score Offer in the Evaluation of Continuing Medical Education? J Eur CME. 2022 Nov 29;11(1):2152941. doi: 10.1080/21614083.2022.2152941. eCollection 2022.'}, {'pmid': '27301257', 'type': 'BACKGROUND', 'citation': "Torisson G, Stavenow L, Minthon L, Londos E. Reliability, validity and clinical correlates of the Quality of Life in Alzheimer's disease (QoL-AD) scale in medical inpatients. Health Qual Life Outcomes. 2016 Jun 14;14:90. doi: 10.1186/s12955-016-0493-8."}, {'pmid': '26596879', 'type': 'BACKGROUND', 'citation': 'Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.'}, {'pmid': '12021425', 'type': 'BACKGROUND', 'citation': 'Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.'}, {'pmid': '40976934', 'type': 'DERIVED', 'citation': 'Ritchie C, Leff B, Sy M, Thacker A, Donelan K, Forester B, Sheehan OC; Dementia Care Quality at Home Writing Group. Feasibility and Acceptability of a Clinician-Caregiver Co-Designed Dementia Care Intervention for Home-Based Primary Care. J Am Geriatr Soc. 2025 Sep 21. doi: 10.1111/jgs.70112. Online ahead of print.'}, {'pmid': '38336779', 'type': 'DERIVED', 'citation': 'Sy M, Thacker A, Sheehan OC, Leff B, Ritchie CS. Caring for caregivers and persons living with dementia under home-based primary care: protocol for an interventional clinical trial. Pilot Feasibility Stud. 2024 Feb 9;10(1):28. doi: 10.1186/s40814-024-01455-x.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.\n\nThe main aims are to:\n\n* Develop and refine HBPC Dementia Care Quality at Home\n* Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention\n\nRelevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.', 'detailedDescription': 'The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.\n\nThe investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nCaregiver participants will:\n\n* be adults (18 years or older)\n* have English fluency and literacy\n* live in the United States\n* live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)\n* anticipate providing care for the next 6 months\n* provide an average 4 hours of supervision or direct assistance per day for the care recipient and\n* have been identified by the practice as experiencing caregiver stress.\n\nStaff participants will:\n\n* be 18 years or older\n* have English fluency and literacy and live in the United States and\n* be part of a HBPC primary care program or closely connected to the practice.\n\nExclusion Criteria:\n\n* Participants under the age 18.\n* Participants who have no English fluency and literacy and do not live in the United States.\n* For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice."}, 'identificationModule': {'nctId': 'NCT05849259', 'briefTitle': 'Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care', 'orgStudyIdInfo': {'id': '2022P003057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dementia Care Quality at Home', 'description': 'Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.', 'interventionNames': ['Other: Dementia Care Quality at Home']}], 'interventions': [{'name': 'Dementia Care Quality at Home', 'type': 'OTHER', 'description': 'Each of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) six modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges.', 'armGroupLabels': ['Dementia Care Quality at Home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Queens Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Christine S Ritchie, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Bruce Leff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Retirement Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Christine S. Ritchie, MD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}