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This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.
Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PAVeD Intervention | Experimental | In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. |
|
| Arm 2: Enhanced Usual Care | Active Comparator | In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAVeD Intervention | Behavioral | In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors. | Three Months, Six Months, Twelve Months Post Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver-Reported Worst Pain | This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity | Baseline, 3 months, 6 months, and 12 months |
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Inclusion Criteria:
Patients will be eligible to participate in the study if they meet the following criteria:
have a documented diagnosis of dementia
receive primary care from the VA
reside outside a long-term care facility
live within 45 minutes of the MEDVAMC
have mild-to-moderate dementia
have no history of aggression in the past year
have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).
have a caregiver who is directly involved with the patient:
report clinically significant pain (either directly or through the caregiver as a proxy)
Exclusion Criteria:
Patients will be excluded if they have had history of aggression in the past year
The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)
Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:
Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mark E. Kunik, MD MPH | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26035086 | Result | Fowler JH, Dannecker K, Stanley M, Wilson N, Snow AL, Kunik ME. Preventing aggression and other secondary features of dementia in elderly persons: Three case studies. Bull Menninger Clin. 2015 Spring;79(2):95-115. doi: 10.1521/bumc.2015.79.2.95. | |
| 22467413 | Result | Bradford A, Shrestha S, Snow AL, Stanley MA, Wilson N, Hersch G, Kunik ME. Managing pain to prevent aggression in people with dementia: a nonpharmacologic intervention. Am J Alzheimers Dis Other Demen. 2012 Feb;27(1):41-7. doi: 10.1177/1533317512439795. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: PAVeD Intervention | 106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute "core" sessions ("Recognizing Pain"; "Recognizing and Responding to Pain and Distress"; "Enhancing Communication"; "Making Daily Activities More Pleasant and Enjoyable") and 2 of 4 elective sessions ("Medical Treatments and Talking to Your Doctor," "Rest and Relaxation Strategies," "Communication Problems and Challenges," and "Increasing Pleasant Activities"), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook. |
| FG001 | Arm 2: Enhanced Usual Care | 107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD's level of pain and depression at baseline, 3 months, 6 months, and 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We evaluated differences in demographics and baseline clinical characteristics between PAVeD and EU-PC subgroups using chi-square tests and independent samples t-tests. however, when distributional assumptions were violated, a non-parametric Fishers Exact or Wilcoxon Mann-Whitney U test was conducted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: PAVeD Intervention | In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. |
| 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 Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors. | 203 community-dwelling Veterans with pain and dementia and their caregivers | Posted | Number | participants | Three Months, Six Months, Twelve Months Post Intervention |
Throughout the study; during sessions and assessments (3, 6, and 12 months)
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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 | Arm 1: PAVeD Intervention | In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deceased - Unrelated to Study | General disorders | Non-systematic Assessment | We cannot specify why these people passed away. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Kunik, MD, MPH | Houston Center for Innovations in Quality, Effectiveness, and Safety | 713-794-8639 | kunik.marke@va.gov |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000374 | Aggression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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|
| Enhanced Usual Care | Behavioral | In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain. |
|
| Patient-reported Worst Pain. |
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. |
| Baseline, 3, 6, and 12 months |
| Caregiver Reported Overall Pain Over the Last Several Weeks | This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Baseline, 3, 6, and 12 months. |
| Patient-reported Overall Pain Over the Last Several Weeks | This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Baseline, 3, 6, and 12 months |
| Depression | Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression. | Baseline, 3, 6, and 12 months |
| Pleasant Events - Short Form - Alzheimer's Disease | The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events. | Baseline, 0, 3, 6, 12 months |
| Caregiver Burden | Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden. | Baseline, 3, 6, 12 months |
| Caregiver-perceived Mutuality | Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale. Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality. | Baseline, 3, 6, 12 months |
| 25107934 | Result | Breland JY, Barrera TL, Snow AL, Sansgiry S, Stanley MA, Wilson N, Amspoker AB, Kunik ME. Correlates of pain intensity in community-dwelling individuals with mild to moderate dementia. Am J Alzheimers Dis Other Demen. 2015 May;30(3):320-5. doi: 10.1177/1533317514545827. Epub 2014 Aug 7. |
| 26955380 | Result | Li J, Snow AL, Wilson N, Stanley MA, Morgan RO, Sansgiry S, Kunik ME. The Quality of Pain Treatment in Community-Dwelling Persons with Dementia. Dement Geriatr Cogn Dis Extra. 2015 Dec 5;5(3):459-70. doi: 10.1159/000441717. eCollection 2015 Sep-Dec. |
| 32026743 | Derived | Amspoker AB, Snow AL, Renn BN, Block P, Pickens S, Morgan RO, Kunik ME. Patient Versus Informal Caregiver Proxy Reports of Pain Interference in Persons With Dementia. J Appl Gerontol. 2021 Apr;40(4):414-422. doi: 10.1177/0733464820902632. Epub 2020 Feb 6. |
| BG001 | Arm 2: Enhanced Usual Care | In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Caregiver age (continuous) | Mean | Standard Deviation | years |
|
| Caregiver gender (categorical) | Number | participants |
|
| Caregiver race/ethnicity (categorical) | Number | participants |
|
| Caregiver income (categorical) | Number | participants |
|
| Patient income (categorical) | Number | participants |
|
| Patient use of psychotropic medications (categorical) | Number | participants |
|
| Relationship of patient to his or her caregiver | Number | participants |
|
| Mini-blessed (continuous) | The mini-blessed measures cognitive impairment and responses to items are summed, resulting in a range of scores from 0 - 28, where higher scores indicate more cognitive impairment. Scores of 0-8 indicate no or minimal impairment, scores 9-19 indicate moderate impairment, and scores between 20-28 indicate severe impairment. | Mean | Standard Deviation | units on a scale |
|
| FAST stage (categorical) | The fast is a measure that ascertains which of the 7 stages of dementia one has: higher scores indicate more severe dementia. Stage 1 is normal adult with no functional decline, Stage 2 is normal older adult with some functional decline, Stage 3 is mild cognitive impairment, Stage 4 is mild dementia, Stage 5 is moderate dementia, Stage 6 is moderately severe dementia, and Stage 7 is severe dementia. Those with FAST scores between 2-6 were eligible for participation. We combined stages 2 and 3 (possible/mild cognitive impairment) and stages 5 and 6 (moderate/moderately severe dementia). | Number | participants |
|
| Geriatric Depression Scale (continuous) | 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression. | Mean | Standard Deviation | units on a scale |
|
| Enjoyment of Pleasant Events (continuous) | For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). Scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events. | Mean | Standard Deviation | units on a scale |
|
| Burden Severity (continuous) | 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 - 88. Higher scores indicate greater caregiver burden. | Mean | Standard Deviation | units on a scale |
|
| Total Mutuality (continuous) | Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality. | Mean | Standard Deviation | units on a scale |
|
| Caregiver-reported Worst Pain (continuous) | One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Mean | Standard Deviation | units on a scale |
|
| Caregiver-reported Overall pain (continuous) | One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Mean | Standard Deviation | units on a scale |
|
| Patient-reported Worst pain (continuous) | One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Mean | Standard Deviation | units on a scale |
|
| Patient-reported Overall Pain | One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Arm 1: PAVeD Intervention | In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101 |
| OG001 | Arm 2: Enhanced Usual Care | In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain. N = 102 |
|
|
|
| Secondary | Caregiver-Reported Worst Pain | This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, 6 months, and 12 months |
|
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|
|
| Secondary | Patient-reported Worst Pain. | This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, and 12 months |
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|
| Secondary | Caregiver Reported Overall Pain Over the Last Several Weeks | This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, and 12 months. |
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| Secondary | Patient-reported Overall Pain Over the Last Several Weeks | This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, and 12 months |
|
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|
|
| Secondary | Depression | Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, and 12 months |
|
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|
|
| Secondary | Pleasant Events - Short Form - Alzheimer's Disease | The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 0, 3, 6, 12 months |
|
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|
|
| Secondary | Caregiver Burden | Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 12 months |
|
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|
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| Secondary | Caregiver-perceived Mutuality | Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale. Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality. | Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6, 12 months |
|
|
|
|
| 6 |
| 101 |
| 0 |
| 101 |
| EG001 | Arm 2: Enhanced Usual Care | In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain. | 13 | 102 | 0 | 102 |
|
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| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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| 6 months |
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| 12 months |
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