Alzheimer Disease
Conditions
Keywords
dementia, acute care, post-acute recovery, family caregivers
Brief summary
This study will address the effectiveness of Family-centered Function Focused Care (Fam-FFC). Fam-FFC is a theoretically-based approach to care in which family caregivers partner with nurses to prevent functional decline and other complications related to hospitalization in older adults with Alzheimer's disease and related dementias. A systematic care pathway promotes information-sharing and decision-making that promotes physical activity, function, and cognitive stimulation during the hospitalization and immediate post-acute period. Our goal in this work is to establish a practical and effective way to optimize function and physical activity; decrease neuropsychiatric symptoms, delirium, and depression; prevent avoidable post-acute care dependency; and prevent unnecessary rehospitalizations and long-stay nursing home admissions, while mitigating family caregiver strain and burden.
Detailed description
Older persons with Alzheimer's disease and related dementias (ADRD) are about two times as likely to be hospitalized as their peers who are cognitively healthy. The care of hospitalized persons with ADRD has traditionally focused on the acute medical problem that led to admission with little attention paid to functional recovery. Older persons with ADRD are at greater risk for functional decline and increased care dependency after discharge due to a combination of intrinsic factors, environmental, policy, and care practices that restrict physical and cognitive activity, and limited staff knowledge of dementia care. Family caregivers (CGs) can play an important role in promoting the functional recovery of hospitalized older adults. They can provide vital information, offer motivation and support of function-focused care, and assume responsibility in varying degrees for post-acute care delivery and coordination. Family-centered FFC (Fam-FFC) incorporates an educational empowerment model for family CGs provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an enabling milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery. In this patient/family-centered care approach, nurses purposefully engage family CGs in the assessment, decision-making, care delivery and evaluation of function-focused care during hospitalization and the 60-day post-acute period. In the proposed project, we will implement Fam-FFC in a cluster randomized trial of 438 patient/CG dyads in six hospital units randomized within three hospitals (73 dyads per unit) to accomplish the following aims: Aim 1: Validate the efficacy of Fam-FFC on physical function (ADLs/ performance and physical activity), delirium occurrence and severity, neuropsychiatric symptoms, and mood; Aim 2: Evaluate the impact of Fam-FFC on family CG-centered outcomes (preparedness for caregiving, strain, burden, and desire to institutionalize); and Aim 3: Evaluate the relative costs for Fam-FFC v. control condition, and calculate health care cost (post-acute health care utilization) and total cost savings for Fam-FFC. We will also evaluate the cultural appropriateness of Fam-FCC for diverse families in our sample. Dyads will be composed of community-residing, hospitalized medical patients with very mild to moderate dementia (0.5 to 2.0 on the Clinical Dementia Rating Scale) and their CG (defined as the primary person providing oversight and support on an ongoing basis). Outcomes will be evaluated at hospital admission, within 72 hours of discharge, and two and six months post-discharge. This study will be a critical next step in delineating how to partner with family CGs to change acute care approaches provided to patients with ADRD so as to optimize function after discharge, and promote delirium abatement and well-being in these individuals. The societal implications of helping older individuals with Alzheimer's disease and related dementias avoid functional decline are enormous in terms of aging in place, quality of life, cost, and caregiver burden. The study findings will be relevant for other areas of behavior change research in acute care, specifically those related to engaging patients and families in health care planning, delivery, and evaluation.
Interventions
BEHAVIORALFamily-centered Function-focused Care (Fam-FFC)
An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an enabling milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: medical patients who: are age ≥65, speak English or Spanish, live in the community prior to admission to the hospital, screen positive for dementia on well-validated scales (Montreal Cognitive Assessment {MoCA} ≤ 25 123-127 and AD8 \>2 128,129), and score 0.5 to 2.0 on the Clinical Dementia Rating Scale; and have a family CG as the designated study partner for the duration of the study. Patient
Exclusion criteria
mild cognitive impairment (CDR 0.5 without functional or ADL impairments), severe dementia (CDR 3), any significant neurological condition associated with cognitive impairment other than dementia (e.g. brain tumor), a major acute psychiatric disorder, have no family caregiver to participate, are enrolled in hospice and/or have a life expectancy of six months or less, are admitted from a nursing home, or experience transfers to another unit for stays longer than 48 hours. Family Inclusion Criteria: age 18 and above whose relatives meet inclusion criteria will be eligible if they can speak and read English or Spanish; and are related to the patient by blood, marriage, adoption, or affinity as a significant other (defined as or by the patient/legally authorized person as the primary person providing oversight and support on an ongoing basis); participate, at a minimum, in the initial assessment and development of FamPath; and able to recall at least two words on the MiniCog Staff nurses (at the conclusion of the intervention at each site) who identify the intervention unit as the primary unit worked, and speak English or Spanish, will be included in focus groups For the exploratory aim of assessing the cultural appropriateness of the intervention, we will recruit family caregivers who self-identify as black, Latino, Asian and white, randomly selected from the Fam-FFC sample. Approximately 10 percent of families from each ethnic group represented in the study will be approached for consent for participation in interviews. (If theoretical saturation is not reached, interviews will continue until saturation is reached). Additionally, the six nurse champions will be consented and interviewed after the study ends in his/her particular unit/setting to provide their perspective on the cultural appropriateness of Fam-FFC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Preparedness | Discharge and 2 and 6 months post-discharge | Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness. |
| Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge | Assessed using the Barthel Index, comparing the change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge. Return to baseline physical function (yes/no) was scored as yes if the participant's functional status was the same as baseline, within five points or less than baseline, or greater than baseline. Scores ranged from 0 to 1, with higher scores representing better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior | Admission, Discharge, 2 and 6 months post-discharge | Assessed by the Brief Neuropsychiatric Inventory with scores ranging from 0 to 36 and higher scores indicating greater behavioral and psychological symptoms of dementia. |
| Moderate Physical Activity Level | admission, discharge, 2 and 6 months post-discharge | Actigraphy data, measured by the MotionWatch 8, includes minutes spent in moderate activity. |
| Depression | admission, discharge, 2 and 6 months post-discharge | Assessed by the Cornell Scale for Depression in Dementia with total scores ranging between 0 to 38 and higher scores indicate more depressive symptoms. |
| Caregiver Strain | Discharge and 2 and 6 months post-discharge | Assessed by the Modified Caregiver Strain Index with total scores ranging from 0 to 26 and higher scores indicating greater caregiver strain. |
| Caregiver Anxiety | Discharge and 2 and 6 months | Assessed by the Hospital Anxiety and Depression subscale with total scores ranging from 0 to 21 and higher scores indicating greater levels of caregiver anxiety. |
| Falls | discharge and 2 and 6 months | Number of falls a week after hospital discharge and 2 and 6 months post discharge. |
| Hospitalizations | discharge and 2 and 6 months | Number of hospitalizations within a week after discharge; number of hospitalizations between discharge to 2 months post-discharge; number of hospitalizations between 2 months post-discharge and 6 months post-discharge. |
| Emergency Room (ER) Visits | discharge and 2 and 6 months | Number of ER visits within a week after discharge; number of ER visits between discharge to 2 months post-discharge; number of ER visits between 2 months post-discharge and 6 months post-discharge. |
| Caregiver Burden | Discharge and 2 and 6 months post discharge. | Assessed using the Short Form Zarit Burden Interview with total scores total scores ranging from 0 to 48, with higher scores corresponding to higher levels of caregiver burden. |
| Delirium Severity | Admission, Discharge, 2 and 6 months post-discharge | Assessed by the Confusion Assessment Method Short Form with scores ranging from 0-7 and higher scores indicating more delirium severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Care Cost | end of intervention at each study site, 12 months after enrollment initiated | cost equals staff and research nurse time (hours worked and training time) to conduct intervention. |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted between November 2017-July 2021 in six medical units across three hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Fam-FFC The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan.
Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an enabling milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period. | 458 |
| Fam-FFC The intervention consists of :Component 1- Environmental and Policy Assessments; Component II- Education of Nursing Staff; Component III-Ongoing Training/Motivation of Nursing Staff. The Fam-FFC Nurse will work with the champions to mentor and motivate nursing staff to provide: (a) role modeling Fam-FFC, reinforcing performance of Fam-FFC, and brainstorming about ways to overcome challenges; (b) highlighting staff role models; Component IV Implementation of the FamPath Pathway which includes: (a) information on the admitting condition, diagnostics, treatment;(b) family/patient education; (c) transitional hand-off to post-acute providers; and (d) post-acute follow-up to provide ongoing education and modification of the function-focused care plan.
Family-centered Function-focused Care (Fam-FFC): An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an enabling milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period. | 3 |
| Attention Control (Fam- FFC Ed-only) Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up). | 464 |
| Attention Control (Fam- FFC Ed-only) Education of the nursing staff in participating hospital units (exactly as offered in treatment sites), and education of family caregivers about hospital orientation and reinforcement of discharge teaching (medications/treatments, medical follow-up). | 3 |
| Total | 928 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 32 | 60 |
| Overall Study | Withdrawal by Subject | 14 | 12 |
Baseline characteristics
| Characteristic | Fam-FFC | Attention Control (Fam- FFC Ed-only) | Total |
|---|---|---|---|
| Age, Categorical caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical caregivers >=65 years | 86 Participants | 102 Participants | 188 Participants |
| Age, Categorical caregivers Between 18 and 65 years | 127 Participants | 120 Participants | 247 Participants |
| Age, Categorical patients <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical patients >=65 years | 229 Participants | 232 Participants | 461 Participants |
| Age, Categorical patients Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous caregivers | 61.0 years STANDARD_DEVIATION 14.3 | 62.6 years STANDARD_DEVIATION 14.1 | 61.8 years STANDARD_DEVIATION 14.2 |
| Age, Continuous patients | 82.1 years STANDARD_DEVIATION 8.4 | 81.1 years STANDARD_DEVIATION 8.3 | 81.5 years STANDARD_DEVIATION 8.4 |
| Ethnicity (NIH/OMB) caregivers Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) caregivers Not Hispanic or Latino | 216 Participants | 221 Participants | 437 Participants |
| Ethnicity (NIH/OMB) caregivers Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) patients Hispanic or Latino | 8 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) patients Not Hispanic or Latino | 221 Participants | 227 Participants | 448 Participants |
| Ethnicity (NIH/OMB) patients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status caregivers Married | 132 Participants | 139 Participants | 271 Participants |
| Marital Status caregivers Other | 86 Participants | 74 Participants | 160 Participants |
| Marital Status caregivers Widowed | 11 Participants | 19 Participants | 30 Participants |
| Marital Status patients Married | 83 Participants | 88 Participants | 171 Participants |
| Marital Status patients Other | 50 Participants | 46 Participants | 96 Participants |
| Marital Status patients Widowed | 96 Participants | 98 Participants | 194 Participants |
| Race (NIH/OMB) caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) caregivers Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) caregivers Black or African American | 85 Participants | 69 Participants | 154 Participants |
| Race (NIH/OMB) caregivers More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) caregivers Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) caregivers White | 133 Participants | 157 Participants | 290 Participants |
| Race (NIH/OMB) patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Asian | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) patients Black or African American | 89 Participants | 76 Participants | 165 Participants |
| Race (NIH/OMB) patients More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) patients White | 134 Participants | 156 Participants | 290 Participants |
| Sex: Female, Male caregivers Female | 166 Participants | 168 Participants | 334 Participants |
| Sex: Female, Male caregivers Male | 63 Participants | 64 Participants | 127 Participants |
| Sex: Female, Male patients Female | 145 Participants | 130 Participants | 275 Participants |
| Sex: Female, Male patients Male | 84 Participants | 102 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 32 / 229 | 60 / 232 |
| other Total, other adverse events | 0 / 229 | 0 / 232 |
| serious Total, serious adverse events | 0 / 229 | 0 / 232 |
Outcome results
Primary
Caregiver Preparedness
Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness.
Time frame: Discharge and 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Caregiver Preparedness | Discharge | 23.7 score on a scale | Standard Deviation 6.65 |
| Fam-FFC | Caregiver Preparedness | 2 months post-discharge | 24.1 score on a scale | Standard Deviation 6.58 |
| Fam-FFC | Caregiver Preparedness | 6 months post-discharge | 26.5 score on a scale | Standard Deviation 6.83 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Preparedness | Discharge | 23.9 score on a scale | Standard Deviation 6.93 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Preparedness | 2 months post-discharge | 25.0 score on a scale | Standard Deviation 6.38 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Preparedness | 6 months post-discharge | 26.2 score on a scale | Standard Deviation 6.63 |
Primary
Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge).
Assessed using the Barthel Index, comparing the change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge. Return to baseline physical function (yes/no) was scored as yes if the participant's functional status was the same as baseline, within five points or less than baseline, or greater than baseline. Scores ranged from 0 to 1, with higher scores representing better outcomes.
Time frame: Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | Admission | 0.68 units on a scale | Standard Error 0.12 |
| Fam-FFC | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | Discharge | 0.77 units on a scale | Standard Error 0.1 |
| Fam-FFC | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | 2-months post discharge | 0.77 units on a scale | Standard Error 0.1 |
| Fam-FFC | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | 6-months post-discharge | 0.66 units on a scale | Standard Error 0.12 |
| Attention Control (Fam- FFC Ed-only) | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | 6-months post-discharge | 0.53 units on a scale | Standard Error 0.14 |
| Attention Control (Fam- FFC Ed-only) | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | Admission | 0.76 units on a scale | Standard Error 0.1 |
| Attention Control (Fam- FFC Ed-only) | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | 2-months post discharge | 0.61 units on a scale | Standard Error 0.13 |
| Attention Control (Fam- FFC Ed-only) | Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). | Discharge | 0.73 units on a scale | Standard Error 0.11 |
Secondary
Behavior
Assessed by the Brief Neuropsychiatric Inventory with scores ranging from 0 to 36 and higher scores indicating greater behavioral and psychological symptoms of dementia.
Time frame: Admission, Discharge, 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Behavior | Admission | 8.4 score on a scale | Standard Deviation 6.6 |
| Fam-FFC | Behavior | Discharge | 6.5 score on a scale | Standard Deviation 6.07 |
| Fam-FFC | Behavior | 2 months post-discharge | 5.3 score on a scale | Standard Deviation 6.03 |
| Fam-FFC | Behavior | 6 months post-discharge | 5.5 score on a scale | Standard Deviation 6.24 |
| Attention Control (Fam- FFC Ed-only) | Behavior | 6 months post-discharge | 4.6 score on a scale | Standard Deviation 5.56 |
| Attention Control (Fam- FFC Ed-only) | Behavior | Admission | 7.2 score on a scale | Standard Deviation 5.55 |
| Attention Control (Fam- FFC Ed-only) | Behavior | 2 months post-discharge | 5.4 score on a scale | Standard Deviation 5.79 |
| Attention Control (Fam- FFC Ed-only) | Behavior | Discharge | 6.3 score on a scale | Standard Deviation 5.81 |
Secondary
Caregiver Anxiety
Assessed by the Hospital Anxiety and Depression subscale with total scores ranging from 0 to 21 and higher scores indicating greater levels of caregiver anxiety.
Time frame: Discharge and 2 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Caregiver Anxiety | Discharge | 5.4 score on a scale | Standard Deviation 4.79 |
| Fam-FFC | Caregiver Anxiety | 2 months post-discharge | 4.7 score on a scale | Standard Deviation 4.78 |
| Fam-FFC | Caregiver Anxiety | 6 months post-discharge | 4.7 score on a scale | Standard Deviation 4.94 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Anxiety | Discharge | 5.2 score on a scale | Standard Deviation 4.72 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Anxiety | 2 months post-discharge | 4.5 score on a scale | Standard Deviation 4.76 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Anxiety | 6 months post-discharge | 4.3 score on a scale | Standard Deviation 4.91 |
Secondary
Caregiver Burden
Assessed using the Short Form Zarit Burden Interview with total scores total scores ranging from 0 to 48, with higher scores corresponding to higher levels of caregiver burden.
Time frame: Discharge and 2 and 6 months post discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Caregiver Burden | Discharge | 10.0 score on a scale | Standard Deviation 9.02 |
| Fam-FFC | Caregiver Burden | 2 months post-discharge | 13.5 score on a scale | Standard Deviation 10.05 |
| Fam-FFC | Caregiver Burden | 6 months post-discharge | 9.0 score on a scale | Standard Deviation 10.64 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Burden | Discharge | 9.7 score on a scale | Standard Deviation 9.79 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Burden | 2 months post-discharge | 12.7 score on a scale | Standard Deviation 9.88 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Burden | 6 months post-discharge | 7.7 score on a scale | Standard Deviation 9.26 |
Secondary
Caregiver Strain
Assessed by the Modified Caregiver Strain Index with total scores ranging from 0 to 26 and higher scores indicating greater caregiver strain.
Time frame: Discharge and 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Caregiver Strain | Discharge | 8.1 score on a scale | Standard Deviation 6.53 |
| Fam-FFC | Caregiver Strain | 2 months post-discharge | 8.1 score on a scale | Standard Deviation 7.02 |
| Fam-FFC | Caregiver Strain | 6 months post-discharge | 6.9 score on a scale | Standard Deviation 6.83 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Strain | Discharge | 7.9 score on a scale | Standard Deviation 6.63 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Strain | 2 months post-discharge | 7.2 score on a scale | Standard Deviation 6.9 |
| Attention Control (Fam- FFC Ed-only) | Caregiver Strain | 6 months post-discharge | 6.5 score on a scale | Standard Deviation 6.32 |
Secondary
Delirium Severity
Assessed by the Confusion Assessment Method Short Form with scores ranging from 0-7 and higher scores indicating more delirium severity.
Time frame: Admission, Discharge, 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Delirium Severity | Admission | 1.6 score on a scale | Standard Deviation 1.71 |
| Fam-FFC | Delirium Severity | Discharge | 1.0 score on a scale | Standard Deviation 1.51 |
| Fam-FFC | Delirium Severity | 2 month post-discharge | .98 score on a scale | Standard Deviation 1.46 |
| Fam-FFC | Delirium Severity | 6 months post-discharge | 1.1 score on a scale | Standard Deviation 1.57 |
| Attention Control (Fam- FFC Ed-only) | Delirium Severity | 6 months post-discharge | 1.0 score on a scale | Standard Deviation 1.46 |
| Attention Control (Fam- FFC Ed-only) | Delirium Severity | Admission | 1.3 score on a scale | Standard Deviation 1.65 |
| Attention Control (Fam- FFC Ed-only) | Delirium Severity | 2 month post-discharge | 1.0 score on a scale | Standard Deviation 1.44 |
| Attention Control (Fam- FFC Ed-only) | Delirium Severity | Discharge | 1.0 score on a scale | Standard Deviation 1.43 |
Secondary
Depression
Assessed by the Cornell Scale for Depression in Dementia with total scores ranging between 0 to 38 and higher scores indicate more depressive symptoms.
Time frame: admission, discharge, 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Depression | Admission | 9.4 score on a scale | Standard Deviation 6.7 |
| Fam-FFC | Depression | Discharge | 7.5 score on a scale | Standard Deviation 6.19 |
| Fam-FFC | Depression | 2 months post-discharge | 6.2 score on a scale | Standard Deviation 6.05 |
| Fam-FFC | Depression | 6 months post-discharge | 6.2 score on a scale | Standard Deviation 6.74 |
| Attention Control (Fam- FFC Ed-only) | Depression | 6 months post-discharge | 5.01 score on a scale | Standard Deviation 5.44 |
| Attention Control (Fam- FFC Ed-only) | Depression | Admission | 9.0 score on a scale | Standard Deviation 5.72 |
| Attention Control (Fam- FFC Ed-only) | Depression | 2 months post-discharge | 6.6 score on a scale | Standard Deviation 5.95 |
| Attention Control (Fam- FFC Ed-only) | Depression | Discharge | 7.4 score on a scale | Standard Deviation 6.02 |
Secondary
Emergency Room (ER) Visits
Number of ER visits within a week after discharge; number of ER visits between discharge to 2 months post-discharge; number of ER visits between 2 months post-discharge and 6 months post-discharge.
Time frame: discharge and 2 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Emergency Room (ER) Visits | Discharge | .06 Emergency room visits | Standard Deviation 0.23 |
| Fam-FFC | Emergency Room (ER) Visits | 2 months post-discharge | .41 Emergency room visits | Standard Deviation 0.8 |
| Fam-FFC | Emergency Room (ER) Visits | 6 months post-discharge | .46 Emergency room visits | Standard Deviation 0.97 |
| Attention Control (Fam- FFC Ed-only) | Emergency Room (ER) Visits | Discharge | .08 Emergency room visits | Standard Deviation 0.29 |
| Attention Control (Fam- FFC Ed-only) | Emergency Room (ER) Visits | 2 months post-discharge | .44 Emergency room visits | Standard Deviation 1.02 |
| Attention Control (Fam- FFC Ed-only) | Emergency Room (ER) Visits | 6 months post-discharge | .35 Emergency room visits | Standard Deviation 0.71 |
Secondary
Falls
Number of falls a week after hospital discharge and 2 and 6 months post discharge.
Time frame: discharge and 2 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Falls | Discharge | .15 Falls | Standard Deviation 0.55 |
| Fam-FFC | Falls | 2 months post-discharge | .52 Falls | Standard Deviation 1.52 |
| Fam-FFC | Falls | 6 months post-discharge | .76 Falls | Standard Deviation 2.71 |
| Attention Control (Fam- FFC Ed-only) | Falls | Discharge | .14 Falls | Standard Deviation 0.66 |
| Attention Control (Fam- FFC Ed-only) | Falls | 2 months post-discharge | .41 Falls | Standard Deviation 1.19 |
| Attention Control (Fam- FFC Ed-only) | Falls | 6 months post-discharge | .57 Falls | Standard Deviation 2.17 |
Secondary
Hospitalizations
Number of hospitalizations within a week after discharge; number of hospitalizations between discharge to 2 months post-discharge; number of hospitalizations between 2 months post-discharge and 6 months post-discharge.
Time frame: discharge and 2 and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Hospitalizations | Discharge | .05 Hospitalizations | Standard Deviation 0.22 |
| Fam-FFC | Hospitalizations | 2 months post-discharge | .33 Hospitalizations | Standard Deviation 0.73 |
| Fam-FFC | Hospitalizations | 6 months post-discharge | .32 Hospitalizations | Standard Deviation 0.86 |
| Attention Control (Fam- FFC Ed-only) | Hospitalizations | Discharge | .10 Hospitalizations | Standard Deviation 0.31 |
| Attention Control (Fam- FFC Ed-only) | Hospitalizations | 2 months post-discharge | .41 Hospitalizations | Standard Deviation 0.98 |
| Attention Control (Fam- FFC Ed-only) | Hospitalizations | 6 months post-discharge | .33 Hospitalizations | Standard Deviation 0.77 |
Secondary
Moderate Physical Activity Level
Actigraphy data, measured by the MotionWatch 8, includes minutes spent in moderate activity.
Time frame: admission, discharge, 2 and 6 months post-discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fam-FFC | Moderate Physical Activity Level | Admission | 4.8 minutes | Standard Deviation 14.11 |
| Fam-FFC | Moderate Physical Activity Level | Discharge | 14.2 minutes | Standard Deviation 42.2 |
| Fam-FFC | Moderate Physical Activity Level | 2 months post-discharge | 23.3 minutes | Standard Deviation 51.65 |
| Fam-FFC | Moderate Physical Activity Level | 6 months post-discharge | 27.3 minutes | Standard Deviation 41.86 |
| Attention Control (Fam- FFC Ed-only) | Moderate Physical Activity Level | 6 months post-discharge | 24.88 minutes | Standard Deviation 43.26 |
| Attention Control (Fam- FFC Ed-only) | Moderate Physical Activity Level | Admission | 8.3 minutes | Standard Deviation 29.35 |
| Attention Control (Fam- FFC Ed-only) | Moderate Physical Activity Level | 2 months post-discharge | 29.9 minutes | Standard Deviation 63.07 |
| Attention Control (Fam- FFC Ed-only) | Moderate Physical Activity Level | Discharge | 19.1 minutes | Standard Deviation 48.86 |
Other Pre-specified
Health Care Cost
cost equals staff and research nurse time (hours worked and training time) to conduct intervention.
Time frame: end of intervention at each study site, 12 months after enrollment initiated
Population: Only participants in the Fam-FFC intervention group were measured and analyzed (i.e., contributed data reported in the table) and were included in the overall number of participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fam-FFC | Health Care Cost | 320 cost in dollars | Standard Deviation 160 |