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DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home
NA trial testing the DEMA-Pro intervention in Subjective Cognitive Decline in 49 participants. Completed in 31 August 2022.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 49 |
| Start date | 1 May 2021 |
| Primary completion | 31 August 2022 |
| Estimated completion | 31 August 2022 |
| Sites | 1 location across United States |
Indiana University
50 and older, any sex, with Subjective Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Physical Function measured by the Outcome and Assessment Information Set Data of Instructive Activities of Daily Living Scale (OASIS-D, IADLs Scale M1800s ).The ADL/IADL composite score ranges from 0 (total independence) to 9 (totally dependent/unable to complete). Higher score represent greater dependence.
| Group | Value | 95% CI |
|---|---|---|
| DEMA-Pro | -4.7 | ± 1.2 |
Psychosocial Well-being-Short-Form.The Psychosocial well-being short form composes 12 items and ranges from 12 to 60. Higher scores represent better quality of life.Change in the mean score and standard deviation was calculated from pre and post DEMA-Pro intervention. 1-5 Likert Scale. 1= not at all, 5= very much or strongly agree
| Group | Value | 95% CI |
|---|---|---|
| DEMA-Pro | 7.7 | ± 4.6 |
Time frame: 1 year 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DEMA-Pro |
|---|---|---|
| Visited ED due to fall and fracture of 2 ribs | Vascular disorders | — |
| Hospitalization | Cardiac disorders | — |
| Visited ED due to high blood pressure 228/119 | Vascular disorders | — |
| Hospitalization due to CHF | Cardiac disorders | — |
| Reaction | System | DEMA-Pro |
|---|---|---|
| Fall without injury | General disorders | — |
Most-reported serious reactions: Visited ED due to fall and fracture of 2 ribs, Hospitalization, Visited ED due to high blood pressure 228/119, Hospitalization due to CHF.
Data from ClinicalTrials.gov NCT04796415 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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