DementiaPhase 3PAVeDNCT01325714
Preventing Aggression in Veterans With Dementia
A Phase 3 study testing PAVeD Intervention in people with Dementia and Aggression, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Aggression, Pain
- What is being tested?
- PAVeD Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Dementia, Aggression, Pain
- Being tested
- PAVeD Intervention, Enhanced Usual Care
- Medical subject headings
- Dementia, Aggression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAVeD InterventionBehavioural
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.
Enhanced Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PAVeD Intervention |
| 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Months, Six Months, Twelve Months Post Intervention
Secondary outcomes (8)
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
Measured: Baseline, 3 months, 6 months, and 12 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark E. Kunik, MD MPH, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325714
- Sponsor's protocol ID
- IIR 09-351
- Acronym
- PAVeD
- Status last verified
- May 2016
- First submitted
- 28 Mar 2011
- Last updated
- 24 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26035086Bradford 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.
PubMed 22467413Breland 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.
PubMed 25107934Li 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.
PubMed 26955380Amspoker 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.
PubMed 32026743
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Aggression in Veterans With Dementia
- ClinicalTrials.gov ID
- NCT01325714
- Acronym / sponsor ID
- PAVeD / IIR 09-351
- Conditions
- Dementia, Aggression, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Posted 19 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: PAVeD Intervention | Experimental | Behavioral: PAVeD InterventionIn 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 | Behavioral: Enhanced Usual CareIn 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAVeD InterventionIn 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. | Behavioural | Arm 1: PAVeD Intervention |
| Enhanced Usual CareIn 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. | Behavioural | Arm 2: Enhanced Usual Care |
Primary outcome
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
Time frame: 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.
8 secondary outcomes
Caregiver-Reported Worst Pain
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient-reported Worst Pain.
Time frame: Baseline, 3, 6, and 12 months
Caregiver Reported Overall Pain Over the Last Several Weeks
Time frame: Baseline, 3, 6, and 12 months.
Patient-reported Overall Pain Over the Last Several Weeks
Time frame: Baseline, 3, 6, and 12 months
Depression
Time frame: Baseline, 3, 6, and 12 months
Pleasant Events - Short Form - Alzheimer's Disease
Time frame: Baseline, 0, 3, 6, 12 months
Caregiver Burden
Time frame: Baseline, 3, 6, 12 months
Caregiver-perceived Mutuality
Time frame: Baseline, 3, 6, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26035086Fowler 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.
- Results publication: PubMed 22467413Bradford 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.
- Results publication: PubMed 25107934Breland 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.
- Results publication: PubMed 26955380Li 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.
- Derived from this study: PubMed 32026743Amspoker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E. Kunik, MD MPH principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PAVeD Intervention in people with Dementia and Aggression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) (time frame: Three Months, Six Months, Twelve Months Post Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01325714, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.