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Clinical Trials/NCT03147222
NCT03147222
Completed
N/A

Hip Fracture Caregiver Intervention - Function Focused Care: Fracture Care at Home

University of Maryland, Baltimore1 site in 1 country1 target enrollmentSeptember 26, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fractures, Bone
Sponsor
University of Maryland, Baltimore
Enrollment
1
Locations
1
Primary Endpoint
Feasibility of the Intervention
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 26, 2018
End Date
December 12, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ann Gruber-Baldini

Professor

University of Maryland, Baltimore

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility of the Intervention

Time Frame: 8 weeks

Data regarding feasibility will include numbers of participants contacted, enrolled, drop-outs/withdrawals, and completing intervention, adverse events, and total time to implement intervention.

Treatment Fidelity

Time Frame: 8 weeks

Treatment fidelity of the intervention will include recording of adherence and logs of intervention tasks and problems by the interdisciplinary care team and FFC coach regarding barriers to implementation of the intervention and open-ended interviews with caregivers about their experiences with the intervention.

Secondary Outcomes

  • Instrumental Activities of Daily Living (IADLs) - fracture participant outcome(8 weeks)
  • Short Physical Performance Battery (SPPB) - fracture participant outcome(8 weeks)
  • Improvement in Knowledge of FFC - caregiver outcome(2 weeks and 8 weeks after the start of the intervention)
  • Self-Efficacy for Functional and Physical Activities - caregiver outcome(8 weeks)
  • Physical Activities of Daily Living (PADLs) - fracture participant outcome(8 weeks)
  • MotionWatch to Monitor Physical Movement - fracture participant outcome(8 weeks)
  • Neuropsychiatric Inventory (NPI) - fracture participant outcome(8 weeks)
  • Outcomes Expectations for Function and Physical Activity - caregiver outcome(8 weeks)
  • Zarit Burden Interview - caregiver outcome(8 weeks)
  • Modified Mini-Mental State Examination (3MS) - fracture participant outcome(8 weeks)
  • Cornell Scale for Depression in Dementia (CSDD) - fracture participant outcome(8 weeks)
  • Adverse Events(8 weeks)
  • Improvement in Performance of FFC - caregiver outcome(3 weeks and 6 weeks after the start of the intervention)
  • Falls Efficacy Scale International (FES-I)(8 weeks)
  • Center for Epidemiologic Studies Depression Scale (CES-D) - caregiver outcome(8 weeks)

Study Sites (1)

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