CfAA: The Care for America's Aging Study
Study Details
Study Description
Brief 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 quality of life among PLWD/CI and their care partners.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Background and rationale
There are growing numbers of people affected by cognitive impairment and ADRD (Alzheimer disease and related dementias). Neuropsychiatric symptoms (NPS) are highly prevalent throughout the entire trajectory of the ADRD spectrum 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. Therefore, there is an urgent need for innovation and development of non-pharmacologic, behavioral interventions to prevent or mitigate NPS and their adverse consequences for older adults along the ADRD spectrum, 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 deliver critical innovations in non-pharmacologic interventions for ADRD. The on-site support provided by HHAs could help to mitigate or prevent NPS among persons living with dementia or cognitive impairment (PLWD/CI), while also reducing caregiving strain for familial care partners. However, there are critical knowledge and care gaps in non-pharmacologic interventions that leverage the essential workforce of HHAs in addressing NPS among PLWD/CI and associated care partner distress. It is a priority to ensure that the knowledge and skill levels of HHAs are adequate to meet the challenges of NPS among PLWD/CI. 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 or to address specific behavioral techniques that can support HHAs in real-time with recognizing and responding to challenging presentations NPS among older PLWD/CI.
Study design and intervention
Care for America's Aging is a randomized pilot study of a novel non-pharmacologic intervention that enhances the knowledge and skills components of home health aide (HHA) training regarding behavioral symptoms associated with cognitive impairment and dementia within a currently deployed statewide curriculum for HHA certification.
The intervention component consists of an enhanced curriculum - an additional 8 hours (2 instructional days) of didactic content and practicum skills training related to recognizing and responding to dementia-related behaviors - which is delivered in addition to a standard curriculum of 100 hours (~20 instructional days) of HHA training that currently qualifies HHA for certificates from the Massachusetts Home Care Aide Council.
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 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.
A block randomization strategy will be used to ensure balance across the 2 groups of patients who receive their HHA services from public versus private-based home care agencies. This will ensure that, no matter how many patients receive care from public or private agencies, the relative proportions of agency type will be balanced across the 2 groups.
Study outcomes and follow-up
Participants will complete questionnaires every two weeks over a six-month follow-up period. Each questionnaire will take about 20 minutes to complete. The questionnaires will ask about behavioral symptoms, mood, 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.
This study will test the preliminary efficacy of the HHA enhanced curriculum intervention, compared to the standard curriculum, for two co-primary outcomes. These co-primary outcomes are: 1) patient levels of behavioral symptoms; 2) patient and care partner quality of life. The study will test the benefits of the enhanced curriculum training by comparing outcomes between dyads receiving services from HHAs with enhanced training and dyads receiving services from HHAs with standard curriculum training. In addition to these pre-specified co-primary outcomes, the study will also secondarily address potential benefits of the enhanced curriculum training on mood, psychosocial, and other behavioral and health outcomes.
If successful, this pilot study will lay the foundation for further NIH Stage Model research projects evaluating the enhanced curriculum for HHAs as a novel non-pharmacologic intervention to optimize behavioral health and well-being for older adults in the Alzheimer disease and related dementias spectrum and their familial care partners.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Home Health Aides with Enhanced Curriculum Training 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). |
Behavioral: Enhanced home health aide training in dementia and dementia-related behaviors
8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides
|
| No Intervention: Home Health Aides with Standard Curriculum Training 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. |
Outcome Measures
Primary Outcome Measures
- Neuropsychiatric Inventory-Questionnaire (NPI-Q) [6 Months]
The 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.
- Patient-Reported Outcomes Measurement Information System Global Health 10-item (PROMIS-10) [6 months]
The PROMIS-10 measures global health-related quality of life (hrQOL) based on physical, mental, and social functioning.
Eligibility Criteria
Criteria
Inclusion Criteria for Patients:
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Age 60 years and above
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Patients in Mass General Brigham healthcare system
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Mild cognitive impairment or dementia diagnosis of no greater than mild-moderate severity
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Discharge plan includes referral to home care services
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As all surveys have been validated in English, we will limit participation to potential participants able to read English.
Exclusion Criteria for Patients:
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Discharge to Medicare short-term rehab only
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Lack of care partner
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Enrolled in palliative care (projected survival < 6 months)
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Clinical severity of dementia that is moderate or greater
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Any active clinical issues barring safe participation
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Montreal Cognitive Assessment (MoCA)-blind score below cutoff
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University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score below cutoff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114-2696 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Olivia I Okereke, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Cella 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.
- Cella 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.
- Cummings 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.
- 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.
- Jeste 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.
- Nasreddine 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. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
- 2022P001618