The Care for America's Aging Study

NCT06021704 | Not Yet Recruiting

• 1 other identifier: 2022P001618
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Dementia With Behavioral Disturbance; Dementia; Alzheimer Disease

Keywords

Improving Home Care; Enhanced Training for Home Health Aides

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Study Arms (2)

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).

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.

Interventions

Enhanced home health aide training in dementia and dementia-related behaviors BEHAVIORAL

8 hours (2 instructional days) of enhanced curriculum dementia-specific instruction for home health aides

Home Health Aides with Enhanced Curriculum Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Related Publications (6)

• 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.

  PMID: 24354328 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 17679641 BACKGROUND

• 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.

  PMID: 7991117 BACKGROUND

• 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.

  PMID: 20685078 BACKGROUND

• 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.

  PMID: 17443116 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Olivia I Okereke, MD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Anable Eme

CONTACT

857-238-6009; VANABLEEME@mgh.harvard.edu

Cerelia Liu

CONTACT

(617) 726-4336; cliu59@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 28, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)