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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR014657-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This study will evaluate whether a home-based targeted education and skill training (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD) and pain/pain-related features more than usual care plus supportive telephone calls. Half of the participants will receive APT and half will receive supportive telephone calls.
Eighty percent of PWD have behavioral or psychological disturbances, including 40% that are aggressive behaviors. The prevalence of pain in PWD is about 60%, and it is a strong predictor of aggression. The biopsychosocial model of pain posits that pain is bidirectionally related to psychological factors (ie, depression) and social support factors (ie, quality of caregiver/PWD relationship) in addition to biological factors. Thus, depression and quality of the caregiver/PWD relationship can be seen as pain-related features. Caregivers are ideally suited to help address pain, depression, and the caregiver/PWD relationship, thus preventing the development of aggression; but they need tools to assist them in identifying and managing these symptoms.
Prior studies of aggression treatment have not examined using a preventive strategy to decrease incidence of aggression in persons with dementia (PWD). Almost all studies have examined use of pharmacologic interventions following development of aggression.This 5-year randomized controlled trial based on the Unmet Needs Model will focus on preventing aggression in PWD with pain and pain-related features by providing the caregiver with targeted education and skill training. PWD and their caregivers will be randomized to APT or to an enhanced usual primary care condition (EU-PC). APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital versatile discs (DVDs)] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. PWD and caregiver outcomes will be collected at baseline, 3, 6 and 12 months.
Data analysis will include both univariate descriptive statistics and inferential statistics, including regression models, repeated measure modeling and Cox proportional hazards models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggression Prevention Training (APT) | Experimental | APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. |
|
| Enhanced Usual Primary Care (EU-PC) | Placebo Comparator | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aggression Prevention Training (APT) | Behavioral |
| ||
| Enhanced Usual Primary Care (EU-PC) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale | Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Burden--Zarit Burden Interview | The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark E. Kunik, M.D., Ph.D. | Baylor College of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33530695 | Derived | Sibley AA, Shrestha S, Lipovac-Dew M, Kunik ME. Examining Depression Symptoms With/Without Coexisting Anxiety Symptoms in Community-Dwelling Persons With Dementia. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:1533317521990267. doi: 10.1177/1533317521990267. |
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The information generated in this proposal aims to prevent the development of aggression in persons with dementia. Clinician and participant manuals are developed for the intervention and will be widely shared through abstracts, presentation, publication and personal communication if the intervention is efficacious. In addition, if the intervention is found to be evidence-based, we will pursue placement on the websites of:
1) Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry for Evidence-based Programs and 2) Rosalynn Carter Institute for Caregiving (RCI) Caregiver Intervention Database. Information about the study will also be available to interested investigators through NIH CRISP, and the Baylor College of Medicine Section of Health Services Research website. Requests to use the information will be considered on a case-by-case basis, following written request to the principal investigator.
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239 signed written informed consent and 233 completed baseline assessments (5 were lost and 1 withdrew after signing consent); 4 were excluded at baseline due to the presence of aggression in the 3 months prior to baseline based on Cohen-Mansfield Agitation Inventory (CMAI); 1 participant withdrew prior to randomization; 228 participants were randomly assigned to a study arm (114 in each group).
2,230 persons with dementia (PWD) were contacted for telephone screening; 253 were interested and eligible for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Aggression Prevention Training (APT) | APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital video disc (DVDs)] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT) |
| FG001 | Enhanced Usual Primary Care (EU-PC) | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aggression Prevention Training (APT) | APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale | Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances. | Posted | Count of Participants | Participants | one year |
|
Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study.
This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aggression Prevention Training (APT) | APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Kunik, MD, MPH, Primary Investigator | Baylor College of Medicine | 713-794-8639 | mkunik@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2020 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D010146 | Pain |
| D000544 | Alzheimer Disease |
| D000374 | Aggression |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Other |
|
| Positive Caregiving Attributes--Positive Aspects of Caregiving Scale | The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals. | one year |
| Behavior Problems--Revised Memory and Behavior Checklist | Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome. | one year |
| Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD) | The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain. | one year |
| Depression--Geriatric Depression Screen (GDS), Caregiver Version | The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression. | one year |
| Caregiver-Patient Relationship Quality--Mutuality Scale | The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity. | one year |
| Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver) | The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure caregiver report of PWD pain. It consists of 4 items assessing the extent to which the the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain. | one year |
| Caregiver death |
|
| Person with dementia (PWD) death |
|
| Entered Long-term Care |
|
| BG001 | Enhanced Usual Primary Care (EU-PC) | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Individual with Dementia-reported Overall Pain | The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain. | Mean | Standard Deviation | units on a scale |
|
| Caregiver-reported Overall Pain | The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure their report of PWD pain. It consists of 4 items assessing extent to which the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. Items are rated on a 0- to 5-point Likert scale (not at all to extremely). A 5th item asks for number of days per week pain was really bad, and a 6th asks for a rating of how much pain interfered with day-to-day activities. We report only on the overall pain item. | Mean | Standard Deviation | units on a scale |
|
| Geriatric Depression Scale (GDS) | The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression. | Mean | Standard Deviation | units on a scale |
|
| Mutuality Scale | The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity. | Mean | Standard Deviation | units on a scale |
|
| Zarit Burden Inventory | The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88. | Mean | Standard Deviation | units on a scale |
|
| Positive Aspects of Caregiving | The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals. | Mean | Standard Deviation | units on a scale |
|
| Revised Memory and Behavior Checklist (RMBC) - Total Frequency | Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Enhanced Usual Primary Care (EU-PC) | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC) |
|
|
|
| Secondary | Caregiver Burden--Zarit Burden Interview | The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Positive Caregiving Attributes--Positive Aspects of Caregiving Scale | The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Behavior Problems--Revised Memory and Behavior Checklist | Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD) | The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Depression--Geriatric Depression Screen (GDS), Caregiver Version | The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Caregiver-Patient Relationship Quality--Mutuality Scale | The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| Secondary | Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver) | The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure caregiver report of PWD pain. It consists of 4 items assessing the extent to which the the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain. | Posted | Mean | Standard Deviation | units on a scale | one year |
|
|
|
|
| 7 |
| 114 |
| 15 |
| 114 |
| 0 |
| 0 |
| EG001 | Enhanced Usual Primary Care (EU-PC) | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC) | 7 | 114 | 18 | 114 | 0 | 0 |
| Hospitalization | General disorders | Non-systematic Assessment |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hospitalization | Endocrine disorders | Non-systematic Assessment |
|
| Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment | No information on cause of death |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
| Death | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Death | Nervous system disorders | Non-systematic Assessment |
|
| Death | Renal and urinary disorders | Non-systematic Assessment |
|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |