search
Back to results

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

Primary Purpose

Subjective Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
the DEMA-Pro intervention
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subjective Cognitive Decline focused on measuring DEMA-Pro, daily meaningful activity, cognitive impairment, caregivers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) Home health service patients aged > 60 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.
  • 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

Exclusion Criteria:

-

Sites / Locations

  • Kindred at Home

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DEMA-Pro

Arm Description

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

Outcomes

Primary Outcome Measures

Physical Function
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

Sense of Well-Being
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
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
OASIS-D sub data of Frequency of rehospitalization rate (M2410)
Number, Types of ER Visits
OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041)
Nursing Home Transfers
OASIS-D sub data of Frequency of transfers to nursing home care (M2410)

Full Information

First Posted
February 3, 2021
Last Updated
October 17, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04796415
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline
Keywords
DEMA-Pro, daily meaningful activity, cognitive impairment, caregivers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEMA-Pro
Arm Type
Experimental
Arm Description
The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions.
Intervention Type
Behavioral
Intervention Name(s)
the DEMA-Pro intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Physical Function
Description
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.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Sense of Well-Being
Description
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
Time Frame
1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
Title
Depression
Description
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.
Time Frame
1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
Title
Hospitalization Rate
Description
OASIS-D sub data of Frequency of rehospitalization rate (M2410)
Time Frame
One year after completing the intervention
Title
Number, Types of ER Visits
Description
OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041)
Time Frame
One year after completing the intervention
Title
Nursing Home Transfers
Description
OASIS-D sub data of Frequency of transfers to nursing home care (M2410)
Time Frame
One year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Lu, PhD, RN
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kindred at Home
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs