Subjective Cognitive Decline
Conditions
Keywords
DEMA-Pro, daily meaningful activity, cognitive impairment, caregivers
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.
Interventions
BEHAVIORALthe 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).
Sponsors
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Nursing Home Transfers | One year after intervention | OASIS-D sub data of Frequency of transfers to nursing home care (M2410) |
Countries
United States
Participant flow
Pre-assignment details
Patient enrollment is reported because patients were the pre-specified participants. Feedback about the intervention was collected from staff, but staff were not participants.
Participants by arm
| Arm | Count |
|---|---|
| DEMA-Pro The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions.
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). | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | discharged from home health service | 3 |
| Overall Study | health issue | 8 |
| Overall Study | lost contact | 1 |
| Overall Study | moving to nursing home | 1 |
| Overall Study | not interested | 12 |
| Overall Study | Other | 4 |
| Overall Study | re-hospitalization | 2 |
Baseline characteristics
| Characteristic | DEMA-Pro |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous Mean Age | 78.5 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Primary Diagnosis Cardiovascular related | 33 Participants |
| Primary Diagnosis Diabetes | 21 Participants |
| Primary Diagnosis Participants with hospitalization risks | 49 Participants |
| Primary Diagnosis Primary Diagnosis related to fracture, surgery and post-surgery care | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 4 / 49 |
Outcome results
Primary
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.
Time frame: Baseline to 6 weeks
Population: 14/18 completed OASIS-D ADLs Scale at start of care (pre- intervention) and when discharged from Home Health Agency(post-intervention) in this Pilot Phase of pragmatic trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEMA-Pro | Physical Function | -4.7 score on a scale | Standard Deviation 1.2 |
Secondary
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.
Time frame: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
Population: The OASIS PHQ-2 was not collected because the current version of OASIS-D does not have PHQ-2 subscale.
Secondary
Hospitalization Rate
OASIS-D sub data of Frequency of rehospitalization rate (M2410)
Time frame: One year after completing the intervention
Population: Outcome data collection was not funded for this measure, data were not collected
Secondary
Number, Types of ER Visits
OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041)
Time frame: One year after completing the intervention
Population: Outcome data collection was not funded for this measure, so data were not collected.
Secondary
Nursing Home Transfers
OASIS-D sub data of Frequency of transfers to nursing home care (M2410)
Time frame: One year after intervention
Population: .Outcome data collection was not funded for this measure, so data were not collected.
Secondary
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
Time frame: 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days
Population: 18 participants psychosocial well-being measures was collected by Home Health Agency Call Center Staff at pre and post DEMA-Pro program..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEMA-Pro | Sense of Well-Being | 7.7 score on a scale | Standard Deviation 4.6 |