Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-12-01
2028-02-28
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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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).
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
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.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Olivia I.Okereke, MD
Physician
Principal Investigators
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Olivia I Okereke, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2022P001618
Identifier Type: -
Identifier Source: org_study_id