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| ID | Type | Description | Link |
|---|---|---|---|
| R61 AG07265-01 | Other Grant/Funding Number | NIA |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEMA-Pro | Experimental | The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the DEMA-Pro intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days |
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Inclusion Criteria for Home Health patients
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Lu, PhD, RN | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred at Home | Indianapolis | Indiana | 46032 | United States |
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Patient enrollment is reported because patients were the pre-specified participants. Feedback about the intervention was collected from staff, but staff were not participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics for patients are included. No baseline characteristics were collected from staff because they were not pre-specified participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 weeks |
|
1 year 3 months
Adverse events for patients, who were the pre-specified participants, are included. Adverse events were not collected or reported for staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visited ED due to fall and fracture of 2 ribs | Vascular disorders | Systematic Assessment | fractured 2 ribs without hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall without injury | General disorders | Systematic Assessment |
Small sample sizes, potential bias due lack of discharge/transfer outcome being collected, lack of true control group
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne Lu, PhD, RN, FGSA, FAAN, Professor, Science of Nursing Care Department | Indiana University School of Nursing | 3172782042 | yuelu@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2023 | Oct 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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|
| 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. | 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days |
| Hospitalization Rate | OASIS-D sub data of Frequency of rehospitalization rate (M2410) | One year after completing the intervention |
| Number, Types of ER Visits | OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041) | One year after completing the intervention |
| Nursing Home Transfers | OASIS-D sub data of Frequency of transfers to nursing home care (M2410) | One year after intervention |
| discharged from home health service |
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| re-hospitalization |
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| moving to nursing home |
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| lost contact |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary Diagnosis | Count of Participants | Participants |
|
|
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| 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 | 18 participants psychosocial well-being measures was collected by Home Health Agency Call Center Staff at pre and post DEMA-Pro program.. | Posted | Mean | Standard Deviation | score on a scale | 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days |
|
|
|
| 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. | The OASIS PHQ-2 was not collected because the current version of OASIS-D does not have PHQ-2 subscale. | Posted | 1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days |
|
|
| Secondary | Hospitalization Rate | OASIS-D sub data of Frequency of rehospitalization rate (M2410) | Outcome data collection was not funded for this measure, data were not collected | Posted | One year after completing the intervention |
|
|
| Secondary | Number, Types of ER Visits | OASIS-D sub data of Frequency unplanned urgent care or hospital ER care (M2301, M2041) | Outcome data collection was not funded for this measure, so data were not collected. | Posted | One year after completing the intervention |
|
|
| Secondary | Nursing Home Transfers | OASIS-D sub data of Frequency of transfers to nursing home care (M2410) | .Outcome data collection was not funded for this measure, so data were not collected. | Posted | One year after intervention |
|
|
| 0 |
| 49 |
| 4 |
| 49 |
| 3 |
| 49 |
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| Hospitalization | Cardiac disorders | Systematic Assessment | due to low blood pressure |
|
| Visited ED due to high blood pressure 228/119 | Vascular disorders | Systematic Assessment |
|
| Hospitalization due to CHF | Cardiac disorders | Systematic Assessment |
|
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