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

Not Applicable

Completed

Conditions: Subjective Cognitive Decline

Interventions: Behavioral: the DEMA-Pro intervention

Registration Number: NCT04796415

Lead Sponsor: Indiana University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DEMA-Pro	the DEMA-Pro intervention	The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions.

Primary Outcome Measures

Name	Time	Method
Physical Function	Baseline to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Sense of Well-Being	1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days	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
Depression	1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days	OASIS-D sub data of PHQ-2 (M1730); The current version of OASIS does not have PhQ-2 items so we did not ask the coach to collect the PHQ-2 data.
Hospitalization Rate	One year after completing the intervention	OASIS-D sub data of Frequency of rehospitalization rate (M2410)
Nursing Home Transfers	One year after intervention	OASIS-D sub data of Frequency of transfers to nursing home care (M2410)
Number, Types of ER Visits	One year after completing the intervention	OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041)