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The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.
The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.
The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Experimental | People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention was to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets were used initially and then monthly (x5) to record mealtimes in the home, and were reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Weight of the PWD was measured initially and monthly (x5). |
|
| Enhanced Usual Condition (EUC) | Placebo Comparator | In the non-treatment respite care centers, an Enhanced Usual Condition was delivered to caregivers of People with Dementia (PWD). This program consisted of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) lead these groups. Weight of the PWD was measured initially and monthly (x5). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partners at Meals | Behavioral | The focus of the intervention was to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. Families recorded three meals including behavior at home each month. |
| Measure | Description | Time Frame |
|---|---|---|
| Monthly Weight in Pounds on a Scale for Person With Dementia | Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
| Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED) | The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure. | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
| Person With Dementia: Quality of Life | The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life. | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
| Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL) | European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Kelechi | MUSC College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32587748 | Background | Amella Krug EJ, Qanungo S, Martin KL, Mueller M, Madisetti M, Kelechi TJ. A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life. BMC Nutr. 2020 Jun 24;6:24. doi: 10.1186/s40795-020-00350-x. eCollection 2020. |
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IPD will be shared with other investigators who have IRB approved studies; data will be anonymized.
Will be shared as approved by the MUSC IRB and from one year after the study closes to five years after the study closes or as long as the Principle Investigator(s) are employed by the University.
Contact the PIs through the College of Nursing
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Using a cluster randomized controlled experimental design based on each Respite Care Center's (RCCs; N=6) respective average monthly client census, RCCs were randomized to either the Partners at Mealtime (PAM) intervention (N=3; RCCs) or the control enhanced usual care (EUC) group (N=3; RCCs). Enrolled PWD/CG dyads were then allocated to the PAM intervention or the enhanced usual care (EUC) control groups based upon their RCC of attendance.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment - Partners at Meals (PAM) | People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention is to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets are used initially and then monthly (x5) to record mealtimes in the home, and are reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Partners at Meals: The focus of the intervention is to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. |
| FG001 | Enhanced Usual Condition (EUC) | In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5). Enhanced Usual Condition: Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participant enrollment includes caregivers and persons with dementia. While we had volunteers, they assisted with intervention delivery but we did not collect baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment - Partners at Meals (PAM) | People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention is to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets are used initially and then monthly (x5) to record mealtimes in the home, and are reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Partners at Meals: The focus of the intervention is to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The overall number of baseline participants includes both caregivers and persons with dementia combined. |
| 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 | Monthly Weight in Pounds on a Scale for Person With Dementia | Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months | Posted | Mean | Standard Deviation | pounds | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
|
6 months
Definition does not differ from the clinicaltrials.gov definition. Participant enrollment includes caregivers and persons with dementia (PWD). While we had volunteers, they assisted with intervention delivery hence we did not collect any adverse events from them.
Additionally, we have added a description to specify whether the AE was from a PWD or a caregiver.
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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 | Treatment - Partners at Meals (PAM) | People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention is to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets are used initially and then monthly (x5) to record mealtimes in the home, and are reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Partners at Meals: The focus of the intervention is to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal bleeding - caregiver | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 caregiver reported this AE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle spasm - caregiver | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 caregiver reported this AE |
Respite centers (from where the participants were recruited) shut down during the pandemic.
Sometimes participants wifi / internet access was limited Some caregivers expressed perceived burden of study procedures (e.g., taking pictures during mealtime and uploading) High staff / volunteer turnover in respite centers Lack of caregiver interest in participating in research
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Kelechi | Medical University of South Carolina | 843-810-3157 | kelechtj@musc.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 | Jul 12, 2021 | Oct 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2021 | Oct 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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A randomized cluster-design trial will be conducted in two large respite care centers (RCCs) with five sites that serve primarily white and African American persons with dementia. RCCs were randomized to the intervention condition (Partners at Meals; 3 sites) or ['enhanced usual care' (EUC)] (2 sites). The primary unit of analysis is the person with dementia (PWD) and caregiver (CG).
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Participants did not know if they are in a site that is receiving the treatment or in the usual condition site. Randomization is by site, not by individuals.
|
|
| Enhanced Usual Condition | Behavioral | Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites received training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. |
|
|
| This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
| Caregiver: Self Efficacy | The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy. | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
| BG001 | Enhanced Usual Condition (EUC) | In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5). Enhanced Usual Condition: Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Data was collected from dyads which included persons with dementia (PWD) and their caregivers for both treatment and usual care arms | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The overall number of baseline participants includes both caregivers and persons with dementia combined. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The overall number of baseline participants includes both caregivers and persons with dementia combined. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The overall number of baseline participants includes both caregivers and persons with dementia combined. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Enhanced Usual Condition (EUC) | In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5). Enhanced Usual Condition: Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place. |
|
|
| Primary | Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED) | The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure. | Posted | Mean | Standard Error | score on a scale | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
|
|
|
| Primary | Person With Dementia: Quality of Life | The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life. | Posted | Mean | Standard Error | score on a scale | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
|
|
|
| Primary | Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL) | European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
|
|
|
| Primary | Caregiver: Self Efficacy | The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy. | Posted | Mean | Standard Deviation | score on a scale | This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period. |
|
|
|
| 1 |
| 27 |
| 6 |
| 27 |
| 3 |
| 27 |
| EG001 | Enhanced Usual Condition (EUC) | In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5). Enhanced Usual Condition: Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place. | 0 | 21 | 5 | 21 | 1 | 21 |
|
| Seizure - PWD | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Dehydration - caregiver | Metabolism and nutrition disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 caregiver reported this AE |
|
| Fall - PWD | Social circumstances | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Pneumonia - PWD | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| COVID - PWD | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Anemia - PWD | Blood and lymphatic system disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Rash - PWD | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Arrhythmia and Heart Failure - PWD | Cardiac disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
| Fainting - PWD | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment | Only 1 PWD reported this AE |
|
|
| COVID - PWD | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment | Only 3 PWDs reported this AE |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|