Cognitive ImpairmentCfAANCT06021704
The Care for America's Aging Study
A study testing Enhanced home health aide training in dementia and dementia-related behaviors in people with Cognitive Impairment and Dementia With Behavioral Disturbance, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia With Behavioral Disturbance, Dementia
- What is being tested?
- Enhanced home health aide training in dementia and dementia-related behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years and above
- Patients in Mass General Brigham healthcare system
- Mild cognitive impairment or dementia diagnosis of no greater than mild-moderate severity
- Discharge plan includes referral to home care services
- As all surveys have been validated in English, we will limit participation to potential participants able to read English.
Who cannot join
- Discharge to Medicare short-term rehab only
- Lack of care partner
- Enrolled in palliative care (projected survival < 6 months)
- Clinical severity of dementia that is moderate or greater
- Any active clinical issues barring safe participation
- Montreal Cognitive Assessment (MoCA)-blind score below cutoff
- University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score below cutoff
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
About this study
Official title: Care for America's Aging (CfAA): A Study to Improve Behavioral and Quality of Life Outcomes of Older Adults With Cognitive Impairment and Dementia and Their Care Partners
Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their care partners.
Read the detailed description
Behavioral and psychological symptoms of dementia disorders, also called neuropsychiatric symptoms (NPS), are highly prevalent among persons living with dementia or cognitive impairment (PLWD/CI) and represent major sources of morbidity and distress for patients and their care partners. NPS also predict higher rates of institutionalization - directly undermining the ability to "age in place", which is a critical patient-centered goal for most older adults. Thus, there is an urgent need for innovation and development of non-pharmacologic, behavioral interventions to prevent or mitigate NPS and their adverse consequences, and to provide these interventions in the most-preferred, lowest-cost setting: a person's home. As providers of direct care for older adults in their own homes, home health aides (HHAs) are in a unique position to address this critical need. However, it is a priority to ensure that the knowledge and practical skills levels of HHAs are adequate to meet these identified needs. While existing care frameworks provide excellent tools for understanding and responding to NPS, they were not specifically designed to provide HHAs with enhanced knowledge and skills regarding the full range of NPS encountered in the ADRD (Alzheimer disease and related dementias) spectrum or to address specific behavioral techniques that can support HHAs in real-time with recognizing and responding to NPS among older PLWD/CI.
The Care for America's Aging study is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve behavioral and psychological symptoms and quality of life outcomes among adult persons living with dementia or cognitive impairment, aged 60 years and older, and their familial care partners. This study will test the preliminary efficacy of an HHA enhanced curriculum training intervention, compared to the standard curriculum training, for two co-primary outcomes: 1) patient levels of behavioral symptoms; 2) patient and care partner quality of life scores.
The intervention component consists of an enhanced curriculum - an additional 8 hours (2 instructional days) of didactic content and skills training related to recognizing and responding to dementia-related behaviors - which is delivered in addition to a currently-deployed statewide standard curriculum of 100 hours (~20 instructional days) of home care worker training that qualifies HHA for certificates from the Massachusetts Home Care Aide Council.
Eligible participants will be dyads (pairs, or groups made up of 2 persons) of patients and their care partners. Patients will be persons aged 60 years and above who are patients with the Mass General Brigham healthcare system, have mild cognitive impairment or dementia diagnosis of no greater than moderate severity, are being referred to/planning to use home care services, and able to participate in study procedures. Care partners will be familial caregivers, however family is self-defined.
Sixty dyads of homebound older adult patients with cognitive impairment or dementia (ranging from mild to moderate severity) and their familial care partners will be randomized to receive care from HHAs who have completed either enhanced or standard curriculum HHA training.
Eligible participants will be assigned by chance (like a coin toss) to one of 2 groups: 1) home care from HHAs who completed enhanced curriculum training or 2) home care from HHAs who completed standard curriculum training. Therefore, there will be n=30 patient-care partner dyads in each of the 2 groups, and each dyad will have an equal chance of being assigned to either group.
All study participants will be asked to complete questionnaires every two (2) weeks over a 6-month follow-up period. Study questionnaires will ask about behavioral symptoms, mood, psychosocial, health, and daily functioning. Electronic health records will also be used to collect data regarding patient's health outcomes. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaires. The study will assess whether there are differences in these variables over the 6-month follow-up, comparing dyads randomly assigned to receive care from HHAs with standard curriculum training to dyads randomly assigned to receive care from HHAs enhanced curriculum training.
Primary Hypotheses:
- There will be significantly lower neuropsychiatric symptom levels among patients receiving home care services from HHAs with enhanced curriculum training compared to those receiving home care services from HHAs with standard curriculum training.
- There will be significantly higher health-related quality of life scores among patients and familial care partners receiving home care services from HHAs with enhanced curriculum training compared to those receiving home care services from HHAs with standard curriculum training.
- Being tested
- Enhanced home health aide training in dementia and dementia-related behaviors
- Keywords
- Improving Home Care, Enhanced Training for Home Health Aides
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced home health aide training in dementia and dementia-related behaviorsBehavioural
8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides
| Study group | Role | What they receive |
|---|---|---|
| Home Health Aides with Enhanced Curriculum Training | Experimental | The enhanced curriculum of 108 hours of home health aide (HHA) training will constitute the Experimental arm. This arm consists of the 100 hours of the standard curriculum plus an 8-hour enhanced curriculum that includes additional didactic content and a skills practicum on dementia and recognizing and responding to dementia-related behaviors. As with the standard curriculum, the enhanced curriculum will be delivered by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.). The enhanced component is delivered over an additional 2 instructional days (10% increase in instructional days from the standard curriculum). Receives: Behavioral: Enhanced home health aide training in dementia and dementia-related behaviors |
| Home Health Aides with Standard Curriculum Training | No intervention | The standard curriculum of 100 hours of home health aide (HHA) training will constitute the No Intervention arm. This 100-hour training is the standard curriculum that has been used by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.), for many years to qualify HHAs to receive certificates from the Massachusetts Home Care Aide Council. The standard curriculum includes 75 hours of basic instruction ("ABC's for Direct Care Workers") and 25 hours of additional content on mental health and dementia topics. The standard curriculum is delivered over approximately on month, or 20 instructional days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory-Questionnaire
The Neuropsychiatric Inventory-Questionnaire (NPI-Q) is a measure of neuropsychiatric symptoms which is completed by caregivers about their patient partners. The questionnaire aims to assess both the presence of symptoms and their severity. The score range is 0-36 points, where higher scores indicate greater severity of symptoms.
Measured: 6 Months
Patient-Reported Outcomes Measurement Information System Global Health, 10-item
The Patient-Reported Outcomes Measurement Information System Global Health 10-item (PROMIS-10) measures global health-related quality of life (hrQOL) based on physical, mental, and social functioning. The PROMIS-10 uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; higher scores on the T-score metric indicate higher levels of the measured concept - in this case, higher global health-related quality of life.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- N=60 dyads of older adult patients with cognitive impairment up to mild-to-moderate ADRD and their familial care partners will be randomly assigned in 1:1 ratio (n=30 dyads per group) to receive home care services from one of 2 pools of HHAs: 1) HHAs who completed enhanced curriculum training or 2) HHAs who completed standard curriculum training. A block randomization strategy will be used to ensure balance of relative proportions of patients who receive HHA services from public versus private-based home care agencies.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivia I.Okereke, MD, Massachusetts General Hospital
- Investigators
- Olivia I Okereke, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021704
- Sponsor's protocol ID
- 2022P001618
- Acronym
- CfAA
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Blinded study design; study group data will be analyzed in the aggregate. No Individual Participant Data available to be shared.
Publications
Fraker J, Kales HC, Blazek M, Kavanagh J, Gitlin LN. The role of the occupational therapist in the management of neuropsychiatric symptoms of dementia in clinical settings. Occup Ther Health Care. 2014 Jan;28(1):4-20. doi: 10.3109/07380577.2013.867468.
PubMed 24354328Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
PubMed 17679641Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
PubMed 7991117Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
PubMed 17443116
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care for America's Aging (CfAA): A Study to Improve Behavioral and Quality of Life Outcomes of Older Adults With Cognitive Impairment and Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT06021704
- Acronym / sponsor ID
- CfAA / 2022P001618
- Keywords
- Improving Home Care, Enhanced Training for Home Health Aides
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Sep 2023 (actual)
- 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.
Care for America's Aging is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve: 1) behavioral symptoms of older adult persons living with dementia or cognitive impairment (PLWD/CI) and 2) global health-related quality of life among PLWD/CI and their care partners.
Detailed description
Behavioral and psychological symptoms of dementia disorders, also called neuropsychiatric symptoms (NPS), are highly prevalent among persons living with dementia or cognitive impairment (PLWD/CI) and represent major sources of morbidity and distress for patients and their care partners. NPS also predict higher rates of institutionalization - directly undermining the ability to "age in place", which is a critical patient-centered goal for most older adults. Thus, there is an urgent need for innovation and development of non-pharmacologic, behavioral interventions to prevent or mitigate NPS and their adverse consequences, and to provide these interventions in the most-preferred, lowest-cost setting: a person's home. As providers of direct care for older adults in their own homes, home health aides (HHAs) are in a unique position to address this critical need. However, it is a priority to ensure that the knowledge and practical skills levels of HHAs are adequate to meet these identified needs. While existing care frameworks provide excellent tools for understanding and responding to NPS, they were not specifically designed to provide HHAs with enhanced knowledge and skills regarding the full range of NPS encountered in the ADRD (Alzheimer disease and related dementias) spectrum or to address specific behavioral techniques that can support HHAs in real-time with recognizing and responding to NPS among older PLWD/CI.
The Care for America's Aging study is a randomized pilot study investigating whether a home health aide training intervention consisting of enhanced dementia-specific curriculum content will improve behavioral and psychological symptoms and quality of life outcomes among adult persons living with dementia or cognitive impairment, aged 60 years and older, and their familial care partners. This study will test the preliminary efficacy of an HHA enhanced curriculum training intervention, compared to the standard curriculum training, for two co-primary outcomes: 1) patient levels of behavioral symptoms; 2) patient and care partner quality of life scores.
The intervention component consists of an enhanced curriculum - an additional 8 hours (2 instructional days) of didactic content and skills training related to recognizing and responding to dementia-related behaviors - which is delivered in addition to a currently-deployed statewide standard curriculum of 100 hours (~20 instructional days) of home care worker training that qualifies HHA for certificates from the Massachusetts Home Care Aide Council.
Eligible participants will be dyads (pairs, or groups made up of 2 persons) of patients and their care partners. Patients will be persons aged 60 years and above who are patients with the Mass General Brigham healthcare system, have mild cognitive impairment or dementia diagnosis of no greater than moderate severity, are being referred to/planning to use home care services, and able to participate in study procedures. Care partners will be familial caregivers, however family is self-defined.
Sixty dyads of homebound older adult patients with cognitive impairment or dementia (ranging from mild to moderate severity) and their familial care partners will be randomized to receive care from HHAs who have completed either enhanced or standard curriculum HHA training.
Eligible participants will be assigned by chance (like a coin toss) to one of 2 groups: 1) home care from HHAs who completed enhanced curriculum training or 2) home care from HHAs who completed standard curriculum training. Therefore, there will be n=30 patient-care partner dyads in each of the 2 groups, and each dyad will have an equal chance of being assigned to either group.
All study participants will be asked to complete questionnaires every two (2) weeks over a 6-month follow-up period. Study questionnaires will ask about behavioral symptoms, mood, psychosocial, health, and daily functioning. Electronic health records will also be used to collect data regarding patient's health outcomes. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaires. The study will assess whether there are differences in these variables over the 6-month follow-up, comparing dyads randomly assigned to receive care from HHAs with standard curriculum training to dyads randomly assigned to receive care from HHAs enhanced curriculum training.
Primary Hypotheses:
- There will be significantly lower neuropsychiatric symptom levels among patients receiving home care services from HHAs with enhanced curriculum training compared to those receiving home care services from HHAs with standard curriculum training.
- There will be significantly higher health-related quality of life scores among patients and familial care partners receiving home care services from HHAs with enhanced curriculum training compared to those receiving home care services from HHAs with standard curriculum training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- N=60 dyads of older adult patients with cognitive impairment up to mild-to-moderate ADRD and their familial care partners will be randomly assigned in 1:1 ratio (n=30 dyads per group) to receive home care services from one of 2 pools of HHAs: 1) HHAs who completed enhanced curriculum training or 2) HHAs who completed standard curriculum training. A block randomization strategy will be used to ensure balance of relative proportions of patients who receive HHA services from public versus private-based home care agencies.
| Arm | Type | Receives |
|---|---|---|
| Home Health Aides with Enhanced Curriculum Training | Experimental | Behavioral: Enhanced home health aide training in dementia and dementia-related behaviorsThe enhanced curriculum of 108 hours of home health aide (HHA) training will constitute the Experimental arm. This arm consists of the 100 hours of the standard curriculum plus an 8-hour enhanced curriculum that includes additional didactic content and a skills practicum on dementia and recognizing and responding to dementia-related behaviors. As with the standard curriculum, the enhanced curriculum will be delivered by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.). The enhanced component is delivered over an additional 2 instructional days (10% increase in instructional days from the standard curriculum). |
| Home Health Aides with Standard Curriculum Training | No intervention | –The standard curriculum of 100 hours of home health aide (HHA) training will constitute the No Intervention arm. This 100-hour training is the standard curriculum that has been used by the training entity, CCHERS (Center for Community Health Education, Research and Service, Inc.), for many years to qualify HHAs to receive certificates from the Massachusetts Home Care Aide Council. The standard curriculum includes 75 hours of basic instruction ("ABC's for Direct Care Workers") and 25 hours of additional content on mental health and dementia topics. The standard curriculum is delivered over approximately on month, or 20 instructional days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years and above
- Patients in Mass General Brigham healthcare system
- Mild cognitive impairment or dementia diagnosis of no greater than mild-moderate severity
- Discharge plan includes referral to home care services
- As all surveys have been validated in English, we will limit participation to potential participants able to read English.
Key exclusion criteria (7 listed)
- Discharge to Medicare short-term rehab only
- Lack of care partner
- Enrolled in palliative care (projected survival < 6 months)
- Clinical severity of dementia that is moderate or greater
- Any active clinical issues barring safe participation
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 |
|---|---|---|
| Enhanced home health aide training in dementia and dementia-related behaviors8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides | Behavioural | Home Health Aides with Enhanced Curriculum Training |
Primary outcome
Neuropsychiatric Inventory-Questionnaire
Time frame: 6 Months
The Neuropsychiatric Inventory-Questionnaire (NPI-Q) is a measure of neuropsychiatric symptoms which is completed by caregivers about their patient partners. The questionnaire aims to assess both the presence of symptoms and their severity. The score range is 0-36 points, where higher scores indicate greater severity of symptoms.
Patient-Reported Outcomes Measurement Information System Global Health, 10-item
Time frame: 6 months
The Patient-Reported Outcomes Measurement Information System Global Health 10-item (PROMIS-10) measures global health-related quality of life (hrQOL) based on physical, mental, and social functioning. The PROMIS-10 uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population; higher scores on the T-score metric indicate higher levels of the measured concept - in this case, higher global health-related quality of life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 24354328Fraker J, Kales HC, Blazek M, Kavanagh J, Gitlin LN. The role of the occupational therapist in the management of neuropsychiatric symptoms of dementia in clinical settings. Occup Ther Health Care. 2014 Jan;28(1):4-20. doi: 10.3109/07380577.2013.867468.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 17679641Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
- Background: PubMed 7991117Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 17443116Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
- Individual participant dataSharing planned: No. Blinded study design; study group data will be analyzed in the aggregate. No Individual Participant Data available to be shared.
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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.
Olivia I Okereke, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced home health aide training in dementia and dementia-related behaviors in people with Cognitive Impairment and Dementia With Behavioral Disturbance, run by Massachusetts General Hospital 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian Anable Eme (857-238-6009, VANABLEEME@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory-Questionnaire (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT06021704, which also lists 6 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 6 Jul 2026.