DementiaPAVED-TNCT01385007
Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
A study testing Preventing Aggression in Veterans with Dementia (PAVeD) in people with Dementia and Pain, run by Michael E. DeBakey VA Medical Center.
Trial summary
Aggression, a common symptom in persons with dementia, is linked with multiple treatable etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the main predictor of aggression, is a common symptom that is inadequately assessed and treated in persons with dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Preventing Aggression in Veterans with Dementia (PAVeD)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosis of dementia
- pain symptoms documented by the HBPC staff
- residence in a VA designated rural area of Lufkin or Conroe
- presence of a caregiver
- Enrolled in Home Based Primary Care at Michael E DeBakey VA Medical Center
Who cannot join
- display of aggression (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) in the past year
- score of 6 or greater on the Functional Assessment Staging (FAST) scale
- inability to complete by phone a cognitive screening assessment (Telephone Interview for Cognitive Status) or the Philadelphia Geriatric Pain Intensity Scale.
About this study
Aggression, a common symptom in persons with dementia, is linked with multiple treatable etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the main predictor of aggression, is a common symptom that is inadequately assessed and treated in persons with dementia. The main treatment for aggression is antipsychotic medications that are ineffective, costly, and possess considerable adverse side effects. There is a need to test psychosocial interventions that address treatable causes of aggression. Preliminary data suggest the potential utility of Preventing Aggression in Veterans with Dementia (PAVeD), an evidence-based psychoeducational intervention aimed to prevent aggression, with urban dwelling Veterans. PAVeD, an in-home intervention that requires significant clinician time and expense has yet to be evaluated in a rural culture with Veterans who are in poorer health compared to urban Veterans.
The purpose of this intervention demonstration pilot study is to pilot test and evaluate the PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate. Clinical activities directed toward caregivers are supported by policies and procedures set forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to collect data using semi-structured interviews and standardized data collection measures suitable for persons with dementia and their caregivers. The interviews go beyond an evaluation of the outcomes by exploring how the intervention was experienced by the dyad.
Read more
The specific aims of the study are to:
- Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number of dyads recruited and completing the study) by rural Veterans and their caregivers.
- Describe the preliminary outcomes (aggression, depression, Veteran/caregiver relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6 months.
- Understand the cultural beliefs and practices of this population and the impact of the intervention.
The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating aggression with antipsychotic medications. This study is consistent with the goals of the South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve evidence-based practices in rural Veterans and their caregivers. The next step in this program of research is to submit a Health Services Research and Development Service (HSR\&D) application for pilot funding to further develop and test the telephone-based intervention and an appropriate control condition.
- Being tested
- Preventing Aggression in Veterans with Dementia (PAVeD)
- Keywords
- Rural, Veterans, Dementia, Pain, Aggression, residence in a VA designated rural area, presence of a caregiver
- Medical subject headings
- Dementia, Pain, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Aggression in Veterans with Dementia (PAVeD)Behavioural
PAVeD-Telephone consists of three components: pain-management strategies, improvement of patient-collateral communication skills, and behavioral activation through increased pleasant activity planning. The intervention will be primarily geared toward the caregiver; but patients may be involved in some modules, depending on their dementia severity and willingness. The goal of the sessions is to prevent aggression in veterans with dementia. The sessions will include didactics, skill-building, and discussion. Participants will also be provided a copy of the book, Pain Management for Older Adults: A Self-help Guide, as an additional resource for optional reading on the topics covered in the intervention. The intervention is proposed to include six to eight sessions of weekly treatments, lasting 30 minutes to 45 minutes, specifically developed to address the recognition and management of pain in persons with dementia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Aggression
Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects
Measured: 3 months and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385007
- Sponsor's protocol ID
- H-28155
- Acronym
- PAVED-T
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
- ClinicalTrials.gov ID
- NCT01385007
- Acronym / sponsor ID
- PAVED-T / H-28155
- Keywords
- Rural, Veterans, Dementia, Pain, Aggression, residence in a VA designated rural area, presence of a caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Collaborators
- South Central VA Mental Illness Research, Education & Clinical Center
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aggression, a common symptom in persons with dementia, is linked with multiple treatable etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the main predictor of aggression, is a common symptom that is inadequately assessed and treated in persons with dementia. The main treatment for aggression is antipsychotic medications that are ineffective, costly, and possess considerable adverse side effects. There is a need to test psychosocial interventions that address treatable causes of aggression. Preliminary data suggest the potential utility of Preventing Aggression in Veterans with Dementia (PAVeD), an evidence-based psychoeducational intervention aimed to prevent aggression, with urban dwelling Veterans. PAVeD, an in-home intervention that requires significant clinician time and expense has yet to be evaluated in a rural culture with Veterans who are in poorer health compared to urban Veterans.
The purpose of this intervention demonstration pilot study is to pilot test and evaluate the PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate. Clinical activities directed toward caregivers are supported by policies and procedures set forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to collect data using semi-structured interviews and standardized data collection measures suitable for persons with dementia and their caregivers. The interviews go beyond an evaluation of the outcomes by exploring how the intervention was experienced by the dyad.
The specific aims of the study are to:
- Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number of dyads recruited and completing the study) by rural Veterans and their caregivers.
- Describe the preliminary outcomes (aggression, depression, Veteran/caregiver relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6 months.
- Understand the cultural beliefs and practices of this population and the impact of the intervention.
The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating aggression with antipsychotic medications. This study is consistent with the goals of the South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve evidence-based practices in rural Veterans and their caregivers. The next step in this program of research is to submit a Health Services Research and Development Service (HSR\&D) application for pilot funding to further develop and test the telephone-based intervention and an appropriate control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- diagnosis of dementia
- pain symptoms documented by the HBPC staff
- residence in a VA designated rural area of Lufkin or Conroe
- presence of a caregiver
- Enrolled in Home Based Primary Care at Michael E DeBakey VA Medical Center
Key exclusion criteria (3 listed)
- display of aggression (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) in the past year
- score of 6 or greater on the Functional Assessment Staging (FAST) scale
- inability to complete by phone a cognitive screening assessment (Telephone Interview for Cognitive Status) or the Philadelphia Geriatric Pain Intensity Scale.
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 |
|---|---|---|
| Preventing Aggression in Veterans with Dementia (PAVeD)PAVeD-Telephone consists of three components: pain-management strategies, improvement of patient-collateral communication skills, and behavioral activation through increased pleasant activity planning. The intervention will be primarily geared toward the caregiver; but patients may be involved in some modules, depending on their dementia severity and willingness. The goal of the sessions is to prevent aggression in veterans with dementia. The sessions will include didactics, skill-building, and discussion. Participants will also be provided a copy of the book, Pain Management for Older Adults: A Self-help Guide, as an additional resource for optional reading on the topics covered in the intervention. The intervention is proposed to include six to eight sessions of weekly treatments, lasting 30 minutes to 45 minutes, specifically developed to address the recognition and management of pain in persons with dementia. | Behavioural | – |
Primary outcome
Incidence of Aggression
Time frame: 3 months and 6 months post-intervention
Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
Related trials for Dementia
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing Aggression in Veterans with Dementia (PAVeD) in people with Dementia and Pain, run by Michael E. DeBakey VA Medical Center.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of Aggression (time frame: 3 months and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2011.