Aggression, Dementia, Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPAVeD 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.
BEHAVIORALEnhanced 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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: * at least 8 hours per week * sees the patient at least twice a week * and speaks English * 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: * spitting * cursing/verbal aggression * hitting * kicking * grabbing * pushing * throwing * biting * scratching * hurting self/others * tearing things/destroying property * making inappropriate verbal sexual advances * or making inappropriate physical sexual advances 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | Three Months, Six Months, Twelve Months Post Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Worst Pain. | Baseline, 3, 6, and 12 months | 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. |
| Caregiver Reported Overall Pain Over the Last Several Weeks | Baseline, 3, 6, and 12 months. | 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. |
| Patient-reported Overall Pain Over the Last Several Weeks | Baseline, 3, 6, and 12 months | 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. |
| Caregiver-Reported Worst Pain | Baseline, 3 months, 6 months, and 12 months | 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 |
| Pleasant Events - Short Form - Alzheimer's Disease | Baseline, 0, 3, 6, 12 months | 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. |
| Caregiver Burden | Baseline, 3, 6, 12 months | 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. |
| Caregiver-perceived Mutuality | Baseline, 3, 6, 12 months | 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. |
| Depression | Baseline, 3, 6, and 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 102 |
| Total | 203 |
Baseline characteristics
| Characteristic | Arm 1: PAVeD Intervention | Arm 2: Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 78.21 years STANDARD_DEVIATION 8.46 | 80.26 years STANDARD_DEVIATION 8 | 79.24 years STANDARD_DEVIATION 8.27 |
| Burden Severity (continuous) | 28.94 units on a scale STANDARD_DEVIATION 15.27 | 28.63 units on a scale STANDARD_DEVIATION 15.18 | 28.78 units on a scale STANDARD_DEVIATION 15.19 |
| Caregiver age (continuous) | 66.43 years STANDARD_DEVIATION 12.54 | 65.69 years STANDARD_DEVIATION 12.72 | 66.06 years STANDARD_DEVIATION 12.61 |
| Caregiver gender (categorical) Females | 95 participants | 92 participants | 187 participants |
| Caregiver gender (categorical) Males | 6 participants | 10 participants | 16 participants |
| Caregiver income (categorical) $<20,000 | 64 participants | 66 participants | 130 participants |
| Caregiver income (categorical) $20,000-49,999 | 23 participants | 24 participants | 47 participants |
| Caregiver income (categorical) $>=50,000 | 8 participants | 8 participants | 16 participants |
| Caregiver income (categorical) Missing | 6 participants | 4 participants | 10 participants |
| Caregiver race/ethnicity (categorical) Black | 36 participants | 35 participants | 71 participants |
| Caregiver race/ethnicity (categorical) Hispanic or Latino | 17 participants | 17 participants | 34 participants |
| Caregiver race/ethnicity (categorical) Non-Hispanic White | 43 participants | 46 participants | 89 participants |
| Caregiver race/ethnicity (categorical) Other | 5 participants | 4 participants | 9 participants |
| Caregiver-reported Overall pain (continuous) | 2.43 units on a scale STANDARD_DEVIATION 1.13 | 2.06 units on a scale STANDARD_DEVIATION 0.94 | 2.24 units on a scale STANDARD_DEVIATION 1.05 |
| Caregiver-reported Worst Pain (continuous) | 3.28 units on a scale STANDARD_DEVIATION 1.37 | 3.03 units on a scale STANDARD_DEVIATION 1.29 | 3.15 units on a scale STANDARD_DEVIATION 1.34 |
| Enjoyment of Pleasant Events (continuous) | 23.09 units on a scale STANDARD_DEVIATION 5.78 | 24.65 units on a scale STANDARD_DEVIATION 7.39 | 23.87 units on a scale STANDARD_DEVIATION 6.67 |
| FAST stage (categorical) Mild dementia (stage 4) | 23 participants | 24 participants | 47 participants |
| FAST stage (categorical) Missing | 1 participants | 1 participants | 2 participants |
| FAST stage (categorical) Moderate/moderately severe dementia (stages 5-6) | 74 participants | 73 participants | 147 participants |
| FAST stage (categorical) Possible/mild cognitive impairment (stages 2-3) | 3 participants | 4 participants | 7 participants |
| Geriatric Depression Scale (continuous) | 14.33 units on a scale STANDARD_DEVIATION 6.22 | 13.97 units on a scale STANDARD_DEVIATION 6.22 | 14.15 units on a scale STANDARD_DEVIATION 6.21 |
| Mini-blessed (continuous) | 15.21 units on a scale STANDARD_DEVIATION 7.36 | 14.70 units on a scale STANDARD_DEVIATION 7.39 | 14.95 units on a scale STANDARD_DEVIATION 7.36 |
| Patient income (categorical) $<20,000 | 37 participants | 46 participants | 83 participants |
| Patient income (categorical) $20,000-49,999 | 49 participants | 44 participants | 93 participants |
| Patient income (categorical) $>=50,000 | 7 participants | 6 participants | 13 participants |
| Patient income (categorical) Missing | 8 participants | 6 participants | 14 participants |
| Patient-reported Overall Pain | 2.13 units on a scale STANDARD_DEVIATION 1.11 | 1.96 units on a scale STANDARD_DEVIATION 1.24 | 2.04 units on a scale STANDARD_DEVIATION 1.18 |
| Patient-reported Worst pain (continuous) | 3.01 units on a scale STANDARD_DEVIATION 1.3 | 2.84 units on a scale STANDARD_DEVIATION 1.51 | 2.93 units on a scale STANDARD_DEVIATION 1.41 |
| Patient use of psychotropic medications (categorical) Missing | 0 participants | 1 participants | 1 participants |
| Patient use of psychotropic medications (categorical) No | 96 participants | 93 participants | 189 participants |
| Patient use of psychotropic medications (categorical) Yes | 5 participants | 8 participants | 13 participants |
| Race/Ethnicity, Customized Black | 36 participants | 37 participants | 73 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 participants | 15 participants | 30 participants |
| Race/Ethnicity, Customized Non-Hispanic White | 47 participants | 47 participants | 94 participants |
| Race/Ethnicity, Customized Other | 3 participants | 3 participants | 6 participants |
| Relationship of patient to his or her caregiver Nonfamily | 2 participants | 2 participants | 4 participants |
| Relationship of patient to his or her caregiver Other family | 30 participants | 36 participants | 66 participants |
| Relationship of patient to his or her caregiver Spouse | 69 participants | 64 participants | 133 participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 101 Participants | 98 Participants | 199 Participants |
| Total Mutuality (continuous) | 2.93 units on a scale STANDARD_DEVIATION 0.66 | 2.99 units on a scale STANDARD_DEVIATION 0.66 | 2.96 units on a scale STANDARD_DEVIATION 0.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 102 |
| serious Total, serious adverse events | 6 / 101 | 13 / 102 |
Outcome results
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.
Time frame: Three Months, Six Months, Twelve Months Post Intervention
Population: 203 community-dwelling Veterans with pain and dementia and their caregivers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Overal Aggression | 9 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Non-Verbal Aggression | 6 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Non-Verbal Aggression | 6 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Verbal Aggression | 7 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Overall Aggression | 17 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Verbal Aggression | 6 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Non-Verbal Aggression | 5 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Verbal Aggression | 16 participants |
| Arm 1: PAVeD Intervention | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Overall Aggression | 8 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Verbal Aggression | 9 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Overall Aggression | 14 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Overal Aggression | 17 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Overall Aggression | 14 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Non-Verbal Aggression | 8 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Non-Verbal Aggression | 6 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 12 month Non-Verbal Aggression | 10 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 3 month Verbal Aggression | 11 participants |
| Arm 2: Enhanced Usual Care | Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) | 6 month Verbal Aggression | 12 participants |
Comparison: Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm.p-value: 0.1395% CI: [0.45, 1.11]Regression, Cox
Comparison: Comparison of incidence of non-verbal aggression between treatment groups.p-value: 0.3995% CI: [0.43, 1.39]Regression, Cox
Comparison: Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.p-value: 0.8495% CI: [0.51, 1.37]Regression, Cox
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.
Time frame: Baseline, 3, 6, 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Caregiver Burden | Baseline | 28.94 units on a scale | Standard Deviation 15.27 |
| Arm 1: PAVeD Intervention | Caregiver Burden | 3 months | 26.88 units on a scale | Standard Deviation 13.62 |
| Arm 1: PAVeD Intervention | Caregiver Burden | 6 months | 27.84 units on a scale | Standard Deviation 16.48 |
| Arm 1: PAVeD Intervention | Caregiver Burden | 12 months | 27.46 units on a scale | Standard Deviation 14.94 |
| Arm 2: Enhanced Usual Care | Caregiver Burden | 12 months | 30.87 units on a scale | Standard Deviation 16.18 |
| Arm 2: Enhanced Usual Care | Caregiver Burden | Baseline | 28.63 units on a scale | Standard Deviation 15.18 |
| Arm 2: Enhanced Usual Care | Caregiver Burden | 6 months | 32.00 units on a scale | Standard Deviation 17.39 |
| Arm 2: Enhanced Usual Care | Caregiver Burden | 3 months | 30.37 units on a scale | Standard Deviation 16.88 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.p-value: 0.11Mixed Models Analysis
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.
Time frame: Baseline, 3, 6, 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Caregiver-perceived Mutuality | Baseline | 2.93 units on a scale | Standard Deviation 0.66 |
| Arm 1: PAVeD Intervention | Caregiver-perceived Mutuality | 3 months | 3.01 units on a scale | Standard Deviation 0.69 |
| Arm 1: PAVeD Intervention | Caregiver-perceived Mutuality | 6 months | 3.02 units on a scale | Standard Deviation 0.64 |
| Arm 1: PAVeD Intervention | Caregiver-perceived Mutuality | 12 months | 2.82 units on a scale | Standard Deviation 0.72 |
| Arm 2: Enhanced Usual Care | Caregiver-perceived Mutuality | 12 months | 2.74 units on a scale | Standard Deviation 0.84 |
| Arm 2: Enhanced Usual Care | Caregiver-perceived Mutuality | Baseline | 2.99 units on a scale | Standard Deviation 0.66 |
| Arm 2: Enhanced Usual Care | Caregiver-perceived Mutuality | 6 months | 2.78 units on a scale | Standard Deviation 0.79 |
| Arm 2: Enhanced Usual Care | Caregiver-perceived Mutuality | 3 months | 2.82 units on a scale | Standard Deviation 0.8 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.p-value: 0.01Mixed Models Analysis
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.
Time frame: Baseline, 3, 6, and 12 months.
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Caregiver Reported Overall Pain Over the Last Several Weeks | Baseline | 2.43 units on a scale | Standard Deviation 1.13 |
| Arm 1: PAVeD Intervention | Caregiver Reported Overall Pain Over the Last Several Weeks | 3 months | 1.99 units on a scale | Standard Deviation 1.02 |
| Arm 1: PAVeD Intervention | Caregiver Reported Overall Pain Over the Last Several Weeks | 6 months | 1.96 units on a scale | Standard Deviation 1.13 |
| Arm 1: PAVeD Intervention | Caregiver Reported Overall Pain Over the Last Several Weeks | 12 months | 2.00 units on a scale | Standard Deviation 1.11 |
| Arm 2: Enhanced Usual Care | Caregiver Reported Overall Pain Over the Last Several Weeks | 12 months | 1.80 units on a scale | Standard Deviation 1.08 |
| Arm 2: Enhanced Usual Care | Caregiver Reported Overall Pain Over the Last Several Weeks | Baseline | 2.06 units on a scale | Standard Deviation 0.94 |
| Arm 2: Enhanced Usual Care | Caregiver Reported Overall Pain Over the Last Several Weeks | 6 months | 1.96 units on a scale | Standard Deviation 1.12 |
| Arm 2: Enhanced Usual Care | Caregiver Reported Overall Pain Over the Last Several Weeks | 3 months | 1.84 units on a scale | Standard Deviation 0.99 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.p-value: 0.23Mixed Models Analysis
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
Time frame: Baseline, 3 months, 6 months, and 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Caregiver-Reported Worst Pain | Baseline | 3.28 units on a scale | Standard Deviation 1.37 |
| Arm 1: PAVeD Intervention | Caregiver-Reported Worst Pain | 3 months | 2.83 units on a scale | Standard Deviation 1.37 |
| Arm 1: PAVeD Intervention | Caregiver-Reported Worst Pain | 6 months | 2.77 units on a scale | Standard Deviation 1.39 |
| Arm 1: PAVeD Intervention | Caregiver-Reported Worst Pain | 12 months | 2.70 units on a scale | Standard Deviation 1.48 |
| Arm 2: Enhanced Usual Care | Caregiver-Reported Worst Pain | 12 months | 2.58 units on a scale | Standard Deviation 1.39 |
| Arm 2: Enhanced Usual Care | Caregiver-Reported Worst Pain | Baseline | 3.03 units on a scale | Standard Deviation 1.29 |
| Arm 2: Enhanced Usual Care | Caregiver-Reported Worst Pain | 6 months | 2.85 units on a scale | Standard Deviation 1.49 |
| Arm 2: Enhanced Usual Care | Caregiver-Reported Worst Pain | 3 months | 2.91 units on a scale | Standard Deviation 1.4 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.p-value: 0.46Mixed Models Analysis
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.
Time frame: Baseline, 3, 6, and 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Depression | Baseline | 14.33 units on a scale | Standard Deviation 6.22 |
| Arm 1: PAVeD Intervention | Depression | 3 months | 13.17 units on a scale | Standard Deviation 6.75 |
| Arm 1: PAVeD Intervention | Depression | 6 months | 12.81 units on a scale | Standard Deviation 6.82 |
| Arm 1: PAVeD Intervention | Depression | 12 months | 13.12 units on a scale | Standard Deviation 7.2 |
| Arm 2: Enhanced Usual Care | Depression | 12 months | 13.45 units on a scale | Standard Deviation 7.53 |
| Arm 2: Enhanced Usual Care | Depression | Baseline | 13.97 units on a scale | Standard Deviation 6.22 |
| Arm 2: Enhanced Usual Care | Depression | 6 months | 14.01 units on a scale | Standard Deviation 7.09 |
| Arm 2: Enhanced Usual Care | Depression | 3 months | 14.26 units on a scale | Standard Deviation 6.96 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.p-value: 0.42Mixed Models Analysis
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.
Time frame: Baseline, 3, 6, and 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Patient-reported Overall Pain Over the Last Several Weeks | Baseline | 2.13 units on a scale | Standard Deviation 1.11 |
| Arm 1: PAVeD Intervention | Patient-reported Overall Pain Over the Last Several Weeks | 3 months | 1.71 units on a scale | Standard Deviation 1.27 |
| Arm 1: PAVeD Intervention | Patient-reported Overall Pain Over the Last Several Weeks | 6 months | 1.75 units on a scale | Standard Deviation 1.25 |
| Arm 1: PAVeD Intervention | Patient-reported Overall Pain Over the Last Several Weeks | 12 months | 1.77 units on a scale | Standard Deviation 1.35 |
| Arm 2: Enhanced Usual Care | Patient-reported Overall Pain Over the Last Several Weeks | 12 months | 1.72 units on a scale | Standard Deviation 1.4 |
| Arm 2: Enhanced Usual Care | Patient-reported Overall Pain Over the Last Several Weeks | Baseline | 1.96 units on a scale | Standard Deviation 1.24 |
| Arm 2: Enhanced Usual Care | Patient-reported Overall Pain Over the Last Several Weeks | 6 months | 1.92 units on a scale | Standard Deviation 1.16 |
| Arm 2: Enhanced Usual Care | Patient-reported Overall Pain Over the Last Several Weeks | 3 months | 1.66 units on a scale | Standard Deviation 1.37 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.p-value: 0.62Mixed Models Analysis
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.
Time frame: Baseline, 3, 6, and 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Patient-reported Worst Pain. | Baseline | 3.01 units on a scale | Standard Deviation 1.3 |
| Arm 1: PAVeD Intervention | Patient-reported Worst Pain. | 3 months | 2.49 units on a scale | Standard Deviation 1.63 |
| Arm 1: PAVeD Intervention | Patient-reported Worst Pain. | 6 months | 2.35 units on a scale | Standard Deviation 1.54 |
| Arm 1: PAVeD Intervention | Patient-reported Worst Pain. | 12 months | 2.54 units on a scale | Standard Deviation 1.65 |
| Arm 2: Enhanced Usual Care | Patient-reported Worst Pain. | 12 months | 2.46 units on a scale | Standard Deviation 1.81 |
| Arm 2: Enhanced Usual Care | Patient-reported Worst Pain. | Baseline | 2.84 units on a scale | Standard Deviation 1.51 |
| Arm 2: Enhanced Usual Care | Patient-reported Worst Pain. | 6 months | 2.72 units on a scale | Standard Deviation 1.55 |
| Arm 2: Enhanced Usual Care | Patient-reported Worst Pain. | 3 months | 2.41 units on a scale | Standard Deviation 1.62 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.p-value: 0.23Mixed Models Analysis
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.
Time frame: Baseline, 0, 3, 6, 12 months
Population: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PAVeD Intervention | Pleasant Events - Short Form - Alzheimer's Disease | Baseline | 23.09 units on a scale | Standard Deviation 5.78 |
| Arm 1: PAVeD Intervention | Pleasant Events - Short Form - Alzheimer's Disease | 3 months | 24.01 units on a scale | Standard Deviation 6.31 |
| Arm 1: PAVeD Intervention | Pleasant Events - Short Form - Alzheimer's Disease | 6 months | 24.41 units on a scale | Standard Deviation 6.53 |
| Arm 1: PAVeD Intervention | Pleasant Events - Short Form - Alzheimer's Disease | 12 months | 23.54 units on a scale | Standard Deviation 6.51 |
| Arm 2: Enhanced Usual Care | Pleasant Events - Short Form - Alzheimer's Disease | 12 months | 2.74 units on a scale | Standard Deviation 0.84 |
| Arm 2: Enhanced Usual Care | Pleasant Events - Short Form - Alzheimer's Disease | Baseline | 24.65 units on a scale | Standard Deviation 7.39 |
| Arm 2: Enhanced Usual Care | Pleasant Events - Short Form - Alzheimer's Disease | 6 months | 24.06 units on a scale | Standard Deviation 7.5 |
| Arm 2: Enhanced Usual Care | Pleasant Events - Short Form - Alzheimer's Disease | 3 months | 24.81 units on a scale | Standard Deviation 6.94 |
Comparison: Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.p-value: 0.35Mixed Models Analysis