DementiaAPTNCT02380703
Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
A study testing Aggression Prevention Training (APT) and Enhanced Usual Primary Care (EU-PC) in people with Dementia and Pain, run by Baylor College of Medicine.
Trial summary
This study will evaluate whether a home-based targeted education and skill training (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD) and pain/pain-related features more than usual care plus supportive telephone calls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Pain, Alzheimer's Disease
- What is being tested?
- Aggression Prevention Training (APT) and Enhanced Usual Primary Care (EU-PC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2015to 23 Oct 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented diagnosis of dementia
- Clinically significant pain, depression, or caregiver/patient relationship difficulties (either self-report or caregiver proxy-report).
- Receives care from Baylor College of Medicine Geriatric Medicine Associates or Alzheimer's Disease and Memory Disorders Center, or Kelsey Seybold Clinics
- Has an informal caregiver willing to participate in the study who sees the patient at least 8 hours/week and at least twice/week
- Speaks English
- Lives within a 40-mile radius of the coordinating center
Who cannot join
- Advanced dementia based on inability to complete the Mental Impairment Screen-Telephone Version or a Functional Assessment Staging Tool score > 6.
- History of aggression during the one month prior to screening or baseline
- Resides in a long-term care facility
About this study
This study will evaluate whether a home-based targeted education and skill training (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD) and pain/pain-related features more than usual care plus supportive telephone calls. Half of the participants will receive APT and half will receive supportive telephone calls.
Read the detailed description
Eighty percent of PWD have behavioral or psychological disturbances, including 40% that are aggressive behaviors. The prevalence of pain in PWD is about 60%, and it is a strong predictor of aggression. The biopsychosocial model of pain posits that pain is bidirectionally related to psychological factors (ie, depression) and social support factors (ie, quality of caregiver/PWD relationship) in addition to biological factors. Thus, depression and quality of the caregiver/PWD relationship can be seen as pain-related features. Caregivers are ideally suited to help address pain, depression, and the caregiver/PWD relationship, thus preventing the development of aggression; but they need tools to assist them in identifying and managing these symptoms.
Prior studies of aggression treatment have not examined using a preventive strategy to decrease incidence of aggression in persons with dementia (PWD). Almost all studies have examined use of pharmacologic interventions following development of aggression.This 5-year randomized controlled trial based on the Unmet Needs Model will focus on preventing aggression in PWD with pain and pain-related features by providing the caregiver with targeted education and skill training. PWD and their caregivers will be randomized to APT or to an enhanced usual primary care condition (EU-PC). APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital versatile discs (DVDs)] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. PWD and caregiver outcomes will be collected at baseline, 3, 6 and 12 months.
Data analysis will include both univariate descriptive statistics and inferential statistics, including regression models, repeated measure modeling and Cox proportional hazards models.
- Conditions
- Dementia, Pain, Alzheimer's Disease, Aggression, Depression, Interpersonal Relations
- Being tested
- Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
- Keywords
- aggression, dementia, Alzheimer's disease, pain, depression, caregiver, behavioral health, counseling
- Medical subject headings
- Dementia, Pain, Alzheimer Disease, Aggression, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggression Prevention Training (APT)Behavioural
Enhanced Usual Primary Care (EU-PC)Other
| Study group | Role | What they receive |
|---|---|---|
| Aggression Prevention Training (APT) | Experimental | APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Receives: Behavioral: Aggression Prevention Training (APT) |
| Enhanced Usual Primary Care (EU-PC) | Placebo comparator | EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Receives: Other: Enhanced Usual Primary Care (EU-PC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale
Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances.
Measured: one year
Secondary outcomes (7)
Caregiver Burden--Zarit Burden Interview
The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88.
Measured: one year
Positive Caregiving Attributes--Positive Aspects of Caregiving Scale
The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals.
Measured: one year
Behavior Problems--Revised Memory and Behavior Checklist
Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome.
Measured: one year
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)
The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.
Measured: one year
Depression--Geriatric Depression Screen (GDS), Caregiver Version
The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression.
Measured: one year
Caregiver-Patient Relationship Quality--Mutuality Scale
The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity.
Measured: one year
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)
The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure caregiver report of PWD pain. It consists of 4 items assessing the extent to which the the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start5 Feb 2015
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Mark Kunik, Baylor College of Medicine
- Investigators
- Mark E. Kunik, M.D., Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380703
- Sponsor's protocol ID
- H-33720
- Other IDs
- R01NR014657-01A1
- Acronym
- APT
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2015
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: The information generated in this proposal aims to prevent the development of aggression in persons with dementia. Clinician and participant manuals are developed for the intervention and will be widely shared through abstracts, presentation, publication and personal communication if the intervention is efficacious. In addition, if the intervention is found to be evidence-based, we will pursue placement on the websites of: 1\) Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry for Evidence-based Programs and 2) Rosalynn Carter Institute for Caregiving (RCI) Caregiver Intervention Database. Information about the study will also be available to interested investigators through NIH CRISP, and the Baylor College of Medicine Section of Health Services Research website. Requests to use the information will be considered on a case-by-case basis, following written request to the principal investigator.
Publications
Sibley AA, Shrestha S, Lipovac-Dew M, Kunik ME. Examining Depression Symptoms With/Without Coexisting Anxiety Symptoms in Community-Dwelling Persons With Dementia. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:1533317521990267. doi: 10.1177/1533317521990267.
PubMed 33530695
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
- ClinicalTrials.gov ID
- NCT02380703
- Acronym / sponsor ID
- APT / H-33720
- Conditions
- Dementia, Pain, Alzheimer's Disease, Aggression, Depression, Interpersonal Relations
- Keywords
- aggression, dementia, Alzheimer's disease, pain, depression, caregiver, behavioral health, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether a home-based targeted education and skill training (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD) and pain/pain-related features more than usual care plus supportive telephone calls. Half of the participants will receive APT and half will receive supportive telephone calls.
Detailed description
Eighty percent of PWD have behavioral or psychological disturbances, including 40% that are aggressive behaviors. The prevalence of pain in PWD is about 60%, and it is a strong predictor of aggression. The biopsychosocial model of pain posits that pain is bidirectionally related to psychological factors (ie, depression) and social support factors (ie, quality of caregiver/PWD relationship) in addition to biological factors. Thus, depression and quality of the caregiver/PWD relationship can be seen as pain-related features. Caregivers are ideally suited to help address pain, depression, and the caregiver/PWD relationship, thus preventing the development of aggression; but they need tools to assist them in identifying and managing these symptoms.
Prior studies of aggression treatment have not examined using a preventive strategy to decrease incidence of aggression in persons with dementia (PWD). Almost all studies have examined use of pharmacologic interventions following development of aggression.This 5-year randomized controlled trial based on the Unmet Needs Model will focus on preventing aggression in PWD with pain and pain-related features by providing the caregiver with targeted education and skill training. PWD and their caregivers will be randomized to APT or to an enhanced usual primary care condition (EU-PC). APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital versatile discs (DVDs)] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. PWD and caregiver outcomes will be collected at baseline, 3, 6 and 12 months.
Data analysis will include both univariate descriptive statistics and inferential statistics, including regression models, repeated measure modeling and Cox proportional hazards models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aggression Prevention Training (APT) | Experimental | Behavioral: Aggression Prevention Training (APT)APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. |
| Enhanced Usual Primary Care (EU-PC) | Placebo comparator | Other: Enhanced Usual Primary Care (EU-PC)EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosis of dementia
- Clinically significant pain, depression, or caregiver/patient relationship difficulties (either self-report or caregiver proxy-report).
- Receives care from Baylor College of Medicine Geriatric Medicine Associates or Alzheimer's Disease and Memory Disorders Center, or Kelsey Seybold Clinics
- Has an informal caregiver willing to participate in the study who sees the patient at least 8 hours/week and at least twice/week
- Speaks English
Key exclusion criteria (3 listed)
- Advanced dementia based on inability to complete the Mental Impairment Screen-Telephone Version or a Functional Assessment Staging Tool score > 6.
- History of aggression during the one month prior to screening or baseline
- Resides in a long-term care facility
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 |
|---|---|---|
| Aggression Prevention Training (APT) | Behavioural | Aggression Prevention Training (APT) |
| Enhanced Usual Primary Care (EU-PC) | Other | Enhanced Usual Primary Care (EU-PC) |
Primary outcome
Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale
Time frame: one year
Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances.
7 secondary outcomes
Caregiver Burden--Zarit Burden Interview
Time frame: one year
Positive Caregiving Attributes--Positive Aspects of Caregiving Scale
Time frame: one year
Behavior Problems--Revised Memory and Behavior Checklist
Time frame: one year
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)
Time frame: one year
Depression--Geriatric Depression Screen (GDS), Caregiver Version
Time frame: one year
Caregiver-Patient Relationship Quality--Mutuality Scale
Time frame: one year
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33530695Sibley AA, Shrestha S, Lipovac-Dew M, Kunik ME. Examining Depression Symptoms With/Without Coexisting Anxiety Symptoms in Community-Dwelling Persons With Dementia. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:1533317521990267. doi: 10.1177/1533317521990267.
- Individual participant dataSharing planned: No. The information generated in this proposal aims to prevent the development of aggression in persons with dementia. Clinician and participant manuals are developed for the intervention and will be widely shared through abstracts, presentation, publication and personal communication if the intervention is efficacious. In addition, if the intervention is found to be evidence-based, we will pursue placement on the websites of: 1) Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry for Evidence-based Programs and 2) Rosalynn Carter Institute for Caregiving (RCI) Caregiver Intervention Database. Information about the study will also be available to interested investigators through NIH CRISP, and the Baylor College of Medicine Section of Health Services Research website. Requests to use the information will be considered on a case-by-case basis, following written request to the principal investigator.
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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, M.D., Ph.D. principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Aggression Prevention Training (APT) and Enhanced Usual Primary Care (EU-PC) in people with Dementia and Pain, run by Baylor College of Medicine.
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 6 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: finished, as of the sponsor's last update on 11 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2020). 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 Per the Cohen Mansfield Agitation Inventory, Aggression Subscale (time frame: one year). 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 NCT02380703, which also lists 1 linked publication.
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 11 Dec 2020.