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A Family-centered Intervention for Acutely-ill Persons With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03046121
Recruitment Status : Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : April 26, 2022
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Marie Boltz, Penn State University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Family-centered Function-focused Care (Fam-FFC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Reducing Disability Via a Family-centered Intervention for Acutely-ill Persons With Alzheimer's Disease and Related Dementias
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : February 28, 2022
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

No Intervention: 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).

Primary Outcome Measures :
  1. physical function [ Time Frame: 6 months post-discharge ]
    activities of daily living (Barthel Index)

  2. functional performance [ Time Frame: 6 months post-discharge ]
    Timed Chair Rise

  3. Physical activity [ Time Frame: 6 months post-discharge ]
    actigraphy recording activity in set epochs of time

  4. Delirium occurrence [ Time Frame: 6 months post-discharge ]
    any episode of delirium evaluated by the MoCA observation and the Confusion Assessment Method (CAM).

  5. Delirium severity [ Time Frame: 6 months post-discharge ]
    Degree of delirium evaluated with an additive score for six items of the Confusion Assessment Method

  6. Behavior [ Time Frame: 6 months post-discharge ]
    evidence of neuropsychiatric symptoms (Brief Neuropsychiatric Inventory)

  7. Mood [ Time Frame: 6 months post-discharge ]
    evidence of depression (Cornell Scale)

Secondary Outcome Measures :
  1. Preparedness for caregiving [ Time Frame: 6 months post-discharge ]
    how well prepared family caregivers believe they are for multiple domains of caregiving (Preparedness for Caregiving Scale)

  2. Caregiver Strain [ Time Frame: 6 months post-discharge ]
    measures strain (financial, physical, social, psychological, and personal) related to care provision (Modified Caregiver Strain Index)

  3. Caregiver Burden [ Time Frame: 6 months post-discharge ]
    caregiver perception of burden (Zarit Burden Interview)

  4. Desire to Institutionalize [ Time Frame: 6 months post-discharge ]
    6-item scale measuring caregiver desire to transfer the patient to a nursing home (Desire to Institutionalize Scale)

Other Outcome Measures:
  1. health care cost [ Time Frame: end of intervention at each study site, 12 months after enrollment initiated ]
    staff and research nurse time and hours worked, training time (including replacement), supplies, and incentives

  2. post-acute health care utilization [ Time Frame: six months after discharge ]
    cumulative count of emergency room visits, number/days of hospitalizations, and long-term nursing home admissions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03046121

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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Penn State University
National Institutes of Health (NIH)
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marie Boltz, Associate Professor, Penn State University Identifier: NCT03046121    
Other Study ID Numbers: 1R01AG054425-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie Boltz, Penn State University:
acute care
post-acute recovery
family caregivers
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders