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Alzheimer DiseaseNCT03046121

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

A study testing Family-centered Function-focused Care (Fam-FFC) in people with Alzheimer Disease, run by Penn State University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Family-centered Function-focused Care (Fam-FFC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
461 participants
Where
3 sitesUnited States
Study dates
6 Nov 2017to 23 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Lancaster General Medical Center

    Lancaster, Pennsylvania, 17602

  • Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Chester County Hospital

    West Chester, Pennsylvania, 19380

Other trials in United States

About this study

Official title: Reducing Disability Via a Family-centered Intervention for Acutely-ill Persons With Alzheimer's Disease and Related Dementias

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.

Read the 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.

Being tested
Family-centered Function-focused Care (Fam-FFC)
Keywords
dementia, acute care, post-acute recovery, family caregivers
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family-centered Function-focused Care (Fam-FFC)Behavioural

    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.

Study groups in NCT03046121
Study groupRoleWhat they receive
Fam-FFCExperimentalThe 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.
Receives: Behavioral: Family-centered Function-focused Care (Fam-FFC)
Attention Control (Fam- FFC Ed-only)No interventionEducation 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge

  2. Caregiver Preparedness

    Assessed by the Preparedness for Caregiving Scale with scores ranging from 0 to 4 and higher scores indicating greater perceived preparedness.

    Measured: Discharge and 2 and 6 months post-discharge

Secondary outcomes (10)

  1. Delirium Severity

    Assessed by the Confusion Assessment Method Short Form with scores ranging from 0-7 and higher scores indicating more delirium severity.

    Measured: Admission, Discharge, 2 and 6 months post-discharge

  2. 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.

    Measured: Admission, Discharge, 2 and 6 months post-discharge

  3. Moderate Physical Activity Level

    Actigraphy data, measured by the MotionWatch 8, includes minutes spent in moderate activity.

    Measured: admission, discharge, 2 and 6 months post-discharge

  4. 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.

    Measured: admission, discharge, 2 and 6 months post-discharge

  5. Caregiver Strain

    Assessed by the Modified Caregiver Strain Index with total scores ranging from 0 to 26 and higher scores indicating greater caregiver strain.

    Measured: Discharge and 2 and 6 months post-discharge

  6. 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.

    Measured: Discharge and 2 and 6 months post discharge.

  7. 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.

    Measured: Discharge and 2 and 6 months

  8. Falls

    Number of falls a week after hospital discharge and 2 and 6 months post discharge.

    Measured: discharge and 2 and 6 months

  9. 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.

    Measured: discharge and 2 and 6 months

  10. 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.

    Measured: discharge and 2 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2017 (estimated)
  2. Study start6 Nov 2017
  3. Primary completion28 Feb 2022
  4. Study completion23 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03046121
Sponsor's protocol ID
R01AG054425
Other IDs
R01AG054425
Status last verified
May 2024
First submitted
30 Jan 2017
Last updated
6 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuzmik A, Boltz M. Dementia Care Partner Preparedness and Desire to Seek Long-Term Care at Hospital Discharge: Mediating Roles of Care Receiver Clinical Factors. Clin Gerontol. 2025 Oct-Dec;48(5):1057-1068. doi: 10.1080/07317115.2024.2388144. Epub 2024 Aug 5.

    PubMed 39104218

  • Kuzmik A, Best I, Al Harrasi AM, Boltz M. Mediating role of care partner burden among dementia care partners during post-hospital transition. Aging Ment Health. 2024 Dec;28(12):1753-1759. doi: 10.1080/13607863.2024.2370441. Epub 2024 Jun 25.

    PubMed 38915264

  • Kuzmik A, BeLue R, Resnick B, Rodriguez M, Berish D, Galvin JE, Boltz M. Caregiver preparedness is associated with desire to seek long-term care admission of hospitalized persons with dementia. Int J Geriatr Psychiatry. 2023 Sep;38(9):e6006. doi: 10.1002/gps.6006.

    PubMed 37715936

  • Paudel A, Ann Mogle J, Kuzmik A, Resnick B, BeLue R, Galik E, Liu W, Behrens L, Jao YL, Boltz M. Gender differences in interactions and depressive symptoms among hospitalized older patients living with dementia. J Women Aging. 2023 Sep-Oct;35(5):476-486. doi: 10.1080/08952841.2022.2146972. Epub 2022 Nov 26.

    PubMed 36433792

  • Boltz M, Kuzmik A, Resnick B, Trotta R, Mogle J, BeLue R, Leslie D, Galvin JE. Reducing disability via a family centered intervention for acutely ill persons with Alzheimer's disease and related dementias: protocol of a cluster-randomized controlled trial (Fam-FFC study). Trials. 2018 Sep 17;19(1):496. doi: 10.1186/s13063-018-2875-1.

    PubMed 30223870

Questions about this trial

What is this clinical trial studying?

A study testing Family-centered Function-focused Care (Fam-FFC) in people with Alzheimer Disease, run by Penn State University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03046121, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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