Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04238520
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2020-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chen.13047@osu.edu', 'phone': '614-2920474', 'title': 'Dr. Xi Chen, Associate Professor', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We are not able to reach the targeted recruitment goal because of the impact of COVID. Therefore, this trial was inadequately powered to detect the potential differences between the study group and the control group in all of the outcome measures.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'The Adverse Events data were collected for PWD only.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'PWD/CG dyads\n\nControl Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Interventional', 'description': 'PWD/CG dyads\n\nFunctionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Person With Dementia: Oral Hygiene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - PWD', 'description': 'Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.'}, {'id': 'OG001', 'title': 'Interventional - PWD', 'description': 'Study Group Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '23.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 Months', 'description': "We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene.", 'unitOfMeasure': 'percentage change in plaque scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The percentage change in plaque scores between baseline and 3 months was compared between the PWD in the control group and PWD in the study group. 26 PWD (7 in the control and 19 in the study group) with completed data at the baseline. A total of 18 PWD (control group=5 and study group=13) completed the study with data on this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Self-perceived Oral Care-giving Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - FCG', 'description': 'Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.'}, {'id': 'OG001', 'title': 'Interventional - FCG', 'description': 'Study Group: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 Months', 'description': "Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy.", 'unitOfMeasure': 'percentage change in Self-perceived Oral', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The percentage change in Self-perceived Oral Care-giving Efficacy scores between baseline and 3 months was compared between the control and study groups. 26 FCG with complete data were included in the baseline analysis. A total of 18 completed the study with data on this outcome measure'}, {'type': 'SECONDARY', 'title': 'Dyadic Relationship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - PWD/FCG Dyad', 'description': 'Control Group: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.'}, {'id': 'OG001', 'title': 'Interventional - PWD/FCG Dyad', 'description': 'Study Group: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '27.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 Months', 'description': 'Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.', 'unitOfMeasure': 'percentage change in dyadic relationship', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The percentage change in dyadic relationship scores between baseline and 3 months was compared between the control and study groups. 12 dyads with missing data at the baseline were eliminated from the analysis. A total of 8 dyads completed the study with data on this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'PWD/CG dyads\n\nControl Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.'}, {'id': 'FG001', 'title': 'Interventional', 'description': 'PWD/CG dyads\n\nFunctionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '7 dyads = 14 individuals in the control group, 19 dyads = 38 individuals in the study group, Total: 26 dyads = 52 individuals started at the baseline', 'achievements': [{'comment': 'This is the numbers of PWD/CG dyads included in the control group at the baseline.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'This is the numbers of PWD/CG included in the study group at the baseline', 'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'comment': '5 dyads = 10 individuals in the control group, 13 dyads = 26 individuals in the study group, Total: 18 dyads = 36 individuals completed the study', 'achievements': [{'comment': 'This is the numbers of PWD/CG dyads who completed the 3-month follow-up in the control group', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': 'This is the numbers of PWD/CG dyads who completed the 3-month follow-up in the study group', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unsafe home environment for research staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'PWD/CG dyads\n\nControl Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.'}, {'id': 'BG001', 'title': 'Interventional', 'description': 'PWD/CG dyads\n\nFunctionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Participants with dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '69.7', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '16.8', 'groupId': 'BG002'}]}]}, {'title': 'Family caregiver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.0', 'spread': '21.2', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Participants with dementia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Family caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately."}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'PWD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'FCG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '26 pairs of participants with dementia (PWD) and their family caregivers (FCG) (Total=52 participants) were enrolled into the study at the baseline. A descriptive analysis was completed for PWD and FCG, respectively.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-17', 'size': 362572, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-27T14:10', 'hasProtocol': True}, {'date': '2023-02-17', 'size': 110577, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-04T09:15', 'hasProtocol': False}, {'date': '2023-02-17', 'size': 300098, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-27T14:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single Blind- Study participants will be aware of the treatment assigned. The investigator and statistician will not know the group allocation. To check the success or failure of the blinding, the oral examiners and data collectors will be asked after each assessment whether they have been told or know for sure to which group each dyad has been assigned.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control vs. intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2020-01-10', 'resultsFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-08', 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Person With Dementia: Oral Hygiene', 'timeFrame': 'Baseline and 3 Months', 'description': "We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene."}, {'measure': 'Self-perceived Oral Care-giving Efficacy', 'timeFrame': 'Baseline and 3 Months', 'description': "Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy."}], 'secondaryOutcomes': [{'measure': 'Dyadic Relationship', 'timeFrame': 'Baseline and 3 Months', 'description': 'Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Caregiver', 'Family Relations', 'Oral Hygiene', 'Cognitive Impairment', 'Functional Level', 'Oral Health Education'], 'conditions': ['Dementia', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "The specific aims of this study are:\n\nAim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT.\n\nAim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.", 'detailedDescription': "This study aims to develop and evaluate a functionally-tailored oral hygiene intervention to improve oral health for community-dwelling persons with dementia, while also reducing caregiver burden and improving the care partner relationship. The study consists of two phases. First, we will develop a modularized, functionally-tailorable oral care intervention based on caregiver qualitative interviews and existing literature. The second phase will then examine the efficacy and feasibility of the intervention through a randomized controlled trial (3 intervention: 1control ratio)with 40 Persons with Dementia/caregiver dyads. Control participants will receive the standard oral hygiene education currently provided to persons with Dementia during dental care. The Intervention group will receive 4-week, dyadic, hands-on, functionally-tailored oral care intervention. We will collect data at baseline, 4-weeks, and 3 months post intervention. After data collection, the differences in the control and intervention groups in regard to their oral hygiene, behavioral symptoms during oral care, caregiver outcomes (burden, self-efficacy) and care partner relationship will be explored.\n\nThe specific aims of this study are:\n\nAim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT.\n\nAim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.\n\nSub-Aim 2.1 Evaluate the feasibility of the intervention across four domains: acceptability, demand, implementation, and practicality. We will interview the dyads and review their daily oral care logs at both post-intervention and 3-month follow-up, assessing satisfaction with, acceptability of, and actual use of the intervention. Oral care trainers will complete intervention logs following each training session to document the extent of content delivery, diversion from the protocol, resources used, and perceptions about intervention success. Exit interviews with PWD (when possible), CGs, and trainers will be conducted to identify potential barriers, facilitators, and needed changes.\n\nSub-Aim 2.2 Examine the efficacy of the intervention. We hypothesize that both PWD oral hygiene and CG self-efficacy in providing oral care will show clinically significant improvements for the intervention group compared to the control group. Secondary outcomes for PWD (e.g., behavior symptoms during oral care), CGs (e.g., oral care related burden) and the dyadic relationship (e.g., the Dyadic Relationship Scale) will also be explored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Caregivers:\n\n* 18 years or older\n* English-speaking\n* Willing to participate in the study\n\nExclusion Criteria for Caregivers:\n\n* Cognitively impaired\n* Blind, deaf, or severely disabled\n\nInclusion Criteria for Persons with Dementia\n\n* Diagnosis of Dementia\n* Age 50 years or older or 18 years or older with Huntington's Disease\n* Community-dwelling\n* English speaking\n* Have natural teeth\n* Not blind, deaf, or severely disabled\n* Have a caregiver that is age equal or 18+ years old, English speaking, cognitively intact, and willing to participate in the study\n\nExclusion Criteria for Persons with Dementia:\n\n* Joint replacement with a history of prosthetic joint infection\n* Requires immediate dental referrals\n* Have oral cancer or active oral infection or 3) is actively dying.\n* Actively dying"}, 'identificationModule': {'nctId': 'NCT04238520', 'briefTitle': 'Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers', 'orgStudyIdInfo': {'id': '201803835'}, 'secondaryIdInfos': [{'id': 'R21NR017347', 'link': 'https://reporter.nih.gov/quickSearch/R21NR017347', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'PWD/CG dyads', 'interventionNames': ['Behavioral: Control Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'PWD/CG dyads', 'interventionNames': ['Behavioral: Functionally Tailored Oral Care Intervention']}], 'interventions': [{'name': 'Functionally Tailored Oral Care Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.', 'armGroupLabels': ['Interventional']}, {'name': 'Control Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'UIowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Xi Chen, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xi Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xi Chen', 'investigatorAffiliation': 'University of Iowa'}}}}