Trial Outcomes & Findings for Preventing Aggression in Veterans With Dementia (NCT NCT01325714)
NCT ID: NCT01325714
Last Updated: 2016-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
203 participants
Primary outcome timeframe
Three Months, Six Months, Twelve Months Post Intervention
Results posted on
2016-06-24
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
102
|
|
Overall Study
3 Month Assessment
|
82
|
86
|
|
Overall Study
6 Month Asessment
|
75
|
82
|
|
Overall Study
12 Month Assessment
|
67
|
71
|
|
Overall Study
COMPLETED
|
67
|
71
|
|
Overall Study
NOT COMPLETED
|
34
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Aggression in Veterans With Dementia
Baseline characteristics by cohort
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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.
|
Arm 2: Enhanced Usual Care
n=102 Participants
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.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78.21 years
STANDARD_DEVIATION 8.46 • n=5 Participants
|
80.26 years
STANDARD_DEVIATION 8.00 • n=7 Participants
|
79.24 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Caregiver age (continuous)
|
66.43 years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
65.69 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
66.06 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
|
Caregiver gender (categorical)
Males
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Caregiver gender (categorical)
Females
|
95 participants
n=5 Participants
|
92 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Caregiver race/ethnicity (categorical)
Non-Hispanic White
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Caregiver race/ethnicity (categorical)
Black
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Caregiver race/ethnicity (categorical)
Hispanic or Latino
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Caregiver race/ethnicity (categorical)
Other
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Caregiver income (categorical)
$<20,000
|
64 participants
n=5 Participants
|
66 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Caregiver income (categorical)
$20,000-49,999
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Caregiver income (categorical)
$>=50,000
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Caregiver income (categorical)
Missing
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Patient income (categorical)
$<20,000
|
37 participants
n=5 Participants
|
46 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Patient income (categorical)
$20,000-49,999
|
49 participants
n=5 Participants
|
44 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Patient income (categorical)
$>=50,000
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Patient income (categorical)
Missing
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Patient use of psychotropic medications (categorical)
Yes
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Patient use of psychotropic medications (categorical)
No
|
96 participants
n=5 Participants
|
93 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Patient use of psychotropic medications (categorical)
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Relationship of patient to his or her caregiver
Spouse
|
69 participants
n=5 Participants
|
64 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Relationship of patient to his or her caregiver
Other family
|
30 participants
n=5 Participants
|
36 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Relationship of patient to his or her caregiver
Nonfamily
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Mini-blessed (continuous)
|
15.21 units on a scale
STANDARD_DEVIATION 7.36 • n=5 Participants
|
14.70 units on a scale
STANDARD_DEVIATION 7.39 • n=7 Participants
|
14.95 units on a scale
STANDARD_DEVIATION 7.36 • n=5 Participants
|
|
FAST stage (categorical)
Possible/mild cognitive impairment (stages 2-3)
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
FAST stage (categorical)
Mild dementia (stage 4)
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
FAST stage (categorical)
Moderate/moderately severe dementia (stages 5-6)
|
74 participants
n=5 Participants
|
73 participants
n=7 Participants
|
147 participants
n=5 Participants
|
|
FAST stage (categorical)
Missing
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Geriatric Depression Scale (continuous)
|
14.33 units on a scale
STANDARD_DEVIATION 6.22 • n=5 Participants
|
13.97 units on a scale
STANDARD_DEVIATION 6.22 • n=7 Participants
|
14.15 units on a scale
STANDARD_DEVIATION 6.21 • n=5 Participants
|
|
Enjoyment of Pleasant Events (continuous)
|
23.09 units on a scale
STANDARD_DEVIATION 5.78 • n=5 Participants
|
24.65 units on a scale
STANDARD_DEVIATION 7.39 • n=7 Participants
|
23.87 units on a scale
STANDARD_DEVIATION 6.67 • n=5 Participants
|
|
Burden Severity (continuous)
|
28.94 units on a scale
STANDARD_DEVIATION 15.27 • n=5 Participants
|
28.63 units on a scale
STANDARD_DEVIATION 15.18 • n=7 Participants
|
28.78 units on a scale
STANDARD_DEVIATION 15.19 • n=5 Participants
|
|
Total Mutuality (continuous)
|
2.93 units on a scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
2.99 units on a scale
STANDARD_DEVIATION 0.66 • n=7 Participants
|
2.96 units on a scale
STANDARD_DEVIATION 0.66 • n=5 Participants
|
|
Caregiver-reported Worst Pain (continuous)
|
3.28 units on a scale
STANDARD_DEVIATION 1.37 • n=5 Participants
|
3.03 units on a scale
STANDARD_DEVIATION 1.29 • n=7 Participants
|
3.15 units on a scale
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Caregiver-reported Overall pain (continuous)
|
2.43 units on a scale
STANDARD_DEVIATION 1.13 • n=5 Participants
|
2.06 units on a scale
STANDARD_DEVIATION 0.94 • n=7 Participants
|
2.24 units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Patient-reported Worst pain (continuous)
|
3.01 units on a scale
STANDARD_DEVIATION 1.30 • n=5 Participants
|
2.84 units on a scale
STANDARD_DEVIATION 1.51 • n=7 Participants
|
2.93 units on a scale
STANDARD_DEVIATION 1.41 • n=5 Participants
|
|
Patient-reported Overall Pain
|
2.13 units on a scale
STANDARD_DEVIATION 1.11 • n=5 Participants
|
1.96 units on a scale
STANDARD_DEVIATION 1.24 • n=7 Participants
|
2.04 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three Months, Six Months, Twelve Months Post InterventionPopulation: 203 community-dwelling Veterans with pain and dementia and their caregivers
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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
3 month Overall Aggression
|
8 participants
|
14 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
6 month Overal Aggression
|
9 participants
|
17 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
12 month Overall Aggression
|
17 participants
|
14 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
3 month Non-Verbal Aggression
|
6 participants
|
8 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
6 month Non-Verbal Aggression
|
5 participants
|
6 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
12 month Non-Verbal Aggression
|
6 participants
|
10 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
3 month Verbal Aggression
|
7 participants
|
11 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
6 month Verbal Aggression
|
6 participants
|
12 participants
|
|
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
12 month Verbal Aggression
|
16 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in 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
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Caregiver-Reported Worst Pain
Baseline
|
3.28 units on a scale
Standard Deviation 1.37
|
3.03 units on a scale
Standard Deviation 1.29
|
|
Caregiver-Reported Worst Pain
3 months
|
2.83 units on a scale
Standard Deviation 1.37
|
2.91 units on a scale
Standard Deviation 1.40
|
|
Caregiver-Reported Worst Pain
6 months
|
2.77 units on a scale
Standard Deviation 1.39
|
2.85 units on a scale
Standard Deviation 1.49
|
|
Caregiver-Reported Worst Pain
12 months
|
2.70 units on a scale
Standard Deviation 1.48
|
2.58 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in 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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Patient-reported Worst Pain.
Baseline
|
3.01 units on a scale
Standard Deviation 1.30
|
2.84 units on a scale
Standard Deviation 1.51
|
|
Patient-reported Worst Pain.
3 months
|
2.49 units on a scale
Standard Deviation 1.63
|
2.41 units on a scale
Standard Deviation 1.62
|
|
Patient-reported Worst Pain.
6 months
|
2.35 units on a scale
Standard Deviation 1.54
|
2.72 units on a scale
Standard Deviation 1.55
|
|
Patient-reported Worst Pain.
12 months
|
2.54 units on a scale
Standard Deviation 1.65
|
2.46 units on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Caregiver Reported Overall Pain Over the Last Several Weeks
Baseline
|
2.43 units on a scale
Standard Deviation 1.13
|
2.06 units on a scale
Standard Deviation 0.94
|
|
Caregiver Reported Overall Pain Over the Last Several Weeks
3 months
|
1.99 units on a scale
Standard Deviation 1.02
|
1.84 units on a scale
Standard Deviation 0.99
|
|
Caregiver Reported Overall Pain Over the Last Several Weeks
6 months
|
1.96 units on a scale
Standard Deviation 1.13
|
1.96 units on a scale
Standard Deviation 1.12
|
|
Caregiver Reported Overall Pain Over the Last Several Weeks
12 months
|
2.00 units on a scale
Standard Deviation 1.11
|
1.80 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Patient-reported Overall Pain Over the Last Several Weeks
Baseline
|
2.13 units on a scale
Standard Deviation 1.11
|
1.96 units on a scale
Standard Deviation 1.24
|
|
Patient-reported Overall Pain Over the Last Several Weeks
3 months
|
1.71 units on a scale
Standard Deviation 1.27
|
1.66 units on a scale
Standard Deviation 1.37
|
|
Patient-reported Overall Pain Over the Last Several Weeks
6 months
|
1.75 units on a scale
Standard Deviation 1.25
|
1.92 units on a scale
Standard Deviation 1.16
|
|
Patient-reported Overall Pain Over the Last Several Weeks
12 months
|
1.77 units on a scale
Standard Deviation 1.35
|
1.72 units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, and 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.
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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Depression
Baseline
|
14.33 units on a scale
Standard Deviation 6.22
|
13.97 units on a scale
Standard Deviation 6.22
|
|
Depression
3 months
|
13.17 units on a scale
Standard Deviation 6.75
|
14.26 units on a scale
Standard Deviation 6.96
|
|
Depression
6 months
|
12.81 units on a scale
Standard Deviation 6.82
|
14.01 units on a scale
Standard Deviation 7.09
|
|
Depression
12 months
|
13.12 units on a scale
Standard Deviation 7.20
|
13.45 units on a scale
Standard Deviation 7.53
|
SECONDARY outcome
Timeframe: Baseline, 0, 3, 6, 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.
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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Pleasant Events - Short Form - Alzheimer's Disease
Baseline
|
23.09 units on a scale
Standard Deviation 5.78
|
24.65 units on a scale
Standard Deviation 7.39
|
|
Pleasant Events - Short Form - Alzheimer's Disease
3 months
|
24.01 units on a scale
Standard Deviation 6.31
|
24.81 units on a scale
Standard Deviation 6.94
|
|
Pleasant Events - Short Form - Alzheimer's Disease
6 months
|
24.41 units on a scale
Standard Deviation 6.53
|
24.06 units on a scale
Standard Deviation 7.50
|
|
Pleasant Events - Short Form - Alzheimer's Disease
12 months
|
23.54 units on a scale
Standard Deviation 6.51
|
2.74 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in 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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Caregiver Burden
Baseline
|
28.94 units on a scale
Standard Deviation 15.27
|
28.63 units on a scale
Standard Deviation 15.18
|
|
Caregiver Burden
3 months
|
26.88 units on a scale
Standard Deviation 13.62
|
30.37 units on a scale
Standard Deviation 16.88
|
|
Caregiver Burden
6 months
|
27.84 units on a scale
Standard Deviation 16.48
|
32.00 units on a scale
Standard Deviation 17.39
|
|
Caregiver Burden
12 months
|
27.46 units on a scale
Standard Deviation 14.94
|
30.87 units on a scale
Standard Deviation 16.18
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12 monthsPopulation: Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported 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.
Outcome measures
| Measure |
Arm 1: PAVeD Intervention
n=101 Participants
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
|
Arm 2: Enhanced Usual Care
n=102 Participants
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
|
|---|---|---|
|
Caregiver-perceived Mutuality
Baseline
|
2.93 units on a scale
Standard Deviation 0.66
|
2.99 units on a scale
Standard Deviation 0.66
|
|
Caregiver-perceived Mutuality
3 months
|
3.01 units on a scale
Standard Deviation 0.69
|
2.82 units on a scale
Standard Deviation 0.80
|
|
Caregiver-perceived Mutuality
6 months
|
3.02 units on a scale
Standard Deviation 0.64
|
2.78 units on a scale
Standard Deviation 0.79
|
|
Caregiver-perceived Mutuality
12 months
|
2.82 units on a scale
Standard Deviation 0.72
|
2.74 units on a scale
Standard Deviation 0.84
|
Adverse Events
Arm 1: PAVeD Intervention
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Enhanced Usual Care
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: PAVeD Intervention
n=101 participants at risk
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.
|
Arm 2: Enhanced Usual Care
n=102 participants at risk
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.
|
|---|---|---|
|
General disorders
Deceased - Unrelated to Study
|
5.9%
6/101 • Number of events 6 • Throughout the study; during sessions and assessments (3, 6, and 12 months)
|
12.7%
13/102 • Number of events 13 • Throughout the study; during sessions and assessments (3, 6, and 12 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Mark Kunik, MD, MPH
Houston Center for Innovations in Quality, Effectiveness, and Safety
Phone: 713-794-8639
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place