NCT04796415

DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home

Daily Engagement in Meaningful Activities Professional (DEMA-Pro) Intervention for Seniors With Subjective Cognitive Decline and Living at Home

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subjective Cognitive Decline

Interventions

Type	Name	Description
BEHAVIORAL	the DEMA-Pro intervention	Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-03-12
• Last updated: 2023-10-18
• Results posted: 2023-10-18

Locations

1 site across 1 country: United States