Clinical trial NCT03147222: Function Focused Care: Fracture Care at Home
Official title: Hip Fracture Caregiver Intervention - Function Focused Care: Fracture Care at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Dementia
Keywords: fragility fracture
dementia
intervention
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-05-10
Enrollment: 1
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study will evaluate the feasibility of implementing an intervention in the home setting that is specifically designed to coach and mentor caregivers as they assist individuals with Alzheimer's disease and related dementia (ADRD) who have fractured a hip to perform everyday activities and engage in more physical activity.

Detailed description: Prior research by the Baltimore Hip Studies (BHS) has shown that it is possible to improve function, increase physical activity, and improve behavioral symptoms among long term care residents with ADRD and to effectively coach and mentor caregivers through a care practice, Function Focused Care for the Cognitively Impaired (FFC-CI), that focuses on having caregivers teach, cue, model, and assist cognitively impaired individuals to perform functional tasks and engage in physical activity, while minimizing behavioral symptoms. This study will determine if a revised intervention, Function Focused Care for the Cognitively Impaired: Hip Care at Home (aka, Hip Care at Home), can be implemented in a home setting.

The Hip Care at Home intervention will include an initial evaluation of the hip fracture participant, caregiver, and home setting by an interdisciplinary care team including a physical therapist (PT), occupational therapist (OT), and a coach (nurse or nurse's aide) trained in the function focused care (FFC) approach. The FFC coach will then work with the primary informal (family or friend, unpaid) caregiver to integrate the recommended environmental, behavioral, and physical interventions into the home setting, with weekly visits.

Eligibility criteria: FRACTURE PARTICIPANTS

Inclusion Criteria:

* Fragility fracture (hip, spine, femur/thigh, wrist, humerus/arm)
* Pre-fracture diagnosis of Alzheimer's disease or related dementia from chart, informant, or through AD8 score of 2+
* Age 65+ at time of fracture
* Completed usual rehabilitation
* Discharged to the community after rehabilitation ends (i.e., private home or assisted living)
* Availability of a caregiver (i.e., family relative or non-relative, unpaid, informal) providing ADL or IADL care or oversight at least weekly

Exclusion Criteria:

* Pathologic fracture
* Not community-dwelling (e.g., nursing home resident) prior to fracture
* Bedbound during the 6 months prior to fracture
* No caregiver or caregiver refuses study participation
* Study clinician thinks participant is not a good candidate for study

Not returning to the community before one year after fracture (can go to assisted living)

CAREGIVER PARTICIPANTS

Inclusion Criteria:

* Identified as a caregiver (i.e., family relative or non-relative, unpaid, informal) who will help or supervise the fracture participant with ADL or IADL tasks after discharge from rehab
* Helping or supervising thefracture participant with one or more ADL or IADL tasks at least weekly when screened for this study OR plans to be the primary person providing care at least weekly after the fracture participant is discharged from rehab

Exclusion Criteria:

* Not English speaking
* Living more than 40 miles from the hip fracture participant
* Unable to provide informed consent

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 8 weeks
measure: Treatment Fidelity
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical Activities of Daily Living (PADLs) - fracture participant outcome
timeFrame: 8 weeks
measure: Instrumental Activities of Daily Living (IADLs) - fracture participant outcome
timeFrame: 8 weeks
measure: Short Physical Performance Battery (SPPB) - fracture participant outcome
timeFrame: 8 weeks
measure: MotionWatch to Monitor Physical Movement - fracture participant outcome
timeFrame: 8 weeks
measure: Modified Mini-Mental State Examination (3MS) - fracture participant outcome
timeFrame: 8 weeks
measure: Neuropsychiatric Inventory (NPI) - fracture participant outcome
timeFrame: 8 weeks
measure: Cornell Scale for Depression in Dementia (CSDD) - fracture participant outcome
timeFrame: 8 weeks
measure: Adverse Events
timeFrame: 8 weeks
measure: Improvement in Knowledge of FFC - caregiver outcome
timeFrame: 2 weeks and 8 weeks after the start of the intervention
measure: Self-Efficacy for Functional and Physical Activities - caregiver outcome
timeFrame: 8 weeks
measure: Outcomes Expectations for Function and Physical Activity - caregiver outcome
timeFrame: 8 weeks
measure: Improvement in Performance of FFC - caregiver outcome
timeFrame: 3 weeks and 6 weeks after the start of the intervention
measure: Zarit Burden Interview - caregiver outcome
timeFrame: 8 weeks
measure: Center for Epidemiologic Studies Depression Scale (CES-D) - caregiver outcome
timeFrame: 8 weeks
measure: Falls Efficacy Scale International (FES-I)
timeFrame: 8 weeks
Other outcomes:
measure: Assessment of Environment for Impact on Physical Activity
timeFrame: 3 weeks and 6 weeks after the start of the intervention
measure: Goal Attainment
timeFrame: 3 weeks and 6 weeks after the start of the intervention
measure: Care Goal Identification
timeFrame: 3 weeks and 6 weeks after the start of the intervention
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Ann Gruber-Baldini, PhD
role: PRINCIPAL_INVESTIGATOR
References: