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NCT04796415 · ClinicalTrials.gov registry record · NA
DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home
A NA study of Subjective Cognitive Decline, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT04796415 is a NA study of Subjective Cognitive Decline that has completed, run by Indiana University. The registered enrollment target is 49 participants, below the 77-participant average among 6 other Subjective Cognitive Decline trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04796415, a NA study of Subjective Cognitive Decline, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study 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 processe
Conditions Studied
Interventions
- BEHAVIORAL the DEMA-Pro intervention
Study Locations (1)
Indiana
- Kindred at Home - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04796415
The ClinicalTrials.gov registry entry for NCT04796415 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 77-participant average among 6 other Subjective Cognitive Decline trials with a reported enrollment target (36% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Subjective Cognitive Decline appearing as the primary indexed condition, and to 1 intervention - of which the DEMA-Pro intervention is the first listed.
NCT04796415 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT04796415 about?
NCT04796415 is a clinical study titled "DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home". 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 wit...
What is the current status of trial NCT04796415?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2021-05-01. Estimated completion is 2022-08-31.
What conditions does trial NCT04796415 study?
This clinical trial studies the following conditions: Subjective Cognitive Decline.
What interventions are being tested in trial NCT04796415?
The interventions under investigation include: the DEMA-Pro intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04796415?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04796415 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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