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NCT03046121Completed

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

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

Source: ClinicalTrials.gov · Last updated 6 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
461 (actual)
First submitted
30 Jan 2017
Start date
6 Nov 2017
Primary completion date
28 Feb 2022
Lead sponsor
Penn State University
NCT number
NCT03046121

What you commit to

  • Study type: Interventional
  • Participants enrolled: 461
  • From 6 Nov 2017 to the primary completion date, 28 Feb 2022
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lancaster General Medical Center
Coordinator of this site? Confirm its status
LancasterUnited StatesUnknown status
Presbyterian Medical Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Chester County Hospital
Coordinator of this site? Confirm its status
West ChesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.