Clinical trial NCT04796415: DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home
Official title: Daily Engagement in Meaningful Activities Professional (DEMA-Pro) Intervention for Seniors With Subjective Cognitive Decline and Living at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Decline
Keywords: DEMA-Pro
daily meaningful activity
cognitive impairment
caregivers
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-03-12
Enrollment: 49
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: More than 4.4 million patients receive home health services following discharge from the hospital or rehabilitation facility. A substantial number (70%) are older adults with subjective cognitive decline (SCD), an early clinical sign of Alzheimer's disease and related dementia. SCD is associated with diminished activity performance, poor quality-of-life and other adverse health outcomes (e.g., depressive symptoms). Home health patients with SCD often require more time, structure, and guidance to complete tasks and adjust to new skills and environments. Support is especially important during this high-risk period of transition between care settings. We propose a new home health care delivery model in partnership with Kindred at Home (KAH), a division of Humana that encompasses 400 programs across 40 states. DEMA-Pro builds on five preliminary studies that demonstrated high feasibility, acceptability, and positive preliminary effects on health outcomes (physical function, mood, and QoL). DEMA-Pro will be refined for delivery by home health services staff to patients with SCD and their informal caregivers. The overall goal of this research will be to conduct a pragmatic cluster randomized controlled trial (RCT) of DEMA-Pro to improve outcomes in-home health service patients with SCD. In the current R61 pilot phase, we will establish the trial's organizational structure and processes and pilot test DEMA-Pro in 4 home health services sites. In a subsequent trial, we plan to conduct a full pragmatic RCT in a group of Kindred KAH sites comparing DEMA-Pro to usual care. Consistent with the spirit of a pragmatic trial, we will use existing data sources including electronic Medicare OASIS (Outcome and Assessment Information Set) data, and QoL to characterize the cohort and measure outcomes. Thus, the focus of the pilot phase will be to ensure all processes are in place to conduct the subsequent RCT.

Aim 1. Establish the organizational infrastructure and programmatic processes needed to conduct a pragmatic cluster-randomized control trial of the DEMA-Pro intervention versus usual care. A Steering Committee will lead the project and coordinate the activities of 3 Work Groups: Regulatory and Operations; DEMA-Pro Intervention Protocol; and Data Management and Analysis.

Aim 2. Pilot test the DEMA-Pro training protocol in 4 KAH North Region locations and refine as indicated.


Eligibility criteria: Inclusion Criteria for Home Health patients

* 1) Home health service patients aged \> 50 years with SCD, with an OASIS- Cognition Function Subscale Score of 1 or 2 (0 = alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently; 1 = Requires prompting \[cuing, repetition, reminders) only under stressful or unfamiliar conditions; 2 = Requires assistance and some direction in specific situations \[for example, on all tasks involving shifting of attention\] or consistently requires low stimulus environment due to distractibility; 3 = Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time; 4 = Totally dependent due to disturbances such as constant disorientation, coma, persistent vegetative state, or delirium.

Exclusion:

-No caregiver

Criteria for home health services sites are: 1) a minimum of 300 or more new patients/per site annually; 2) at least 50% w/ length of service \> 60 days; 3) staff-to-patient ratio complies with Home Health Agency requirements; 4) no severe state issues. Prior to randomization, sites meeting these criteria will be determined in consultation with the KAH, Clinical Operations Coordinator.

* KAH staff including call-center care coordinators, clinical assessment associates, field-based therapists, and clinical operational coordinator

Primary outcomes:
measure: Physical Function
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Sense of Well-Being
timeFrame: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
measure: Depression
timeFrame: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
measure: Hospitalization Rate
timeFrame: One year after completing the intervention
measure: Number, Types of ER Visits
timeFrame: One year after completing the intervention
measure: Nursing Home Transfers
timeFrame: One year after intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Kindred at Home
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Yvonne Lu, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: