Function Focused Care: Fracture Care at Home

NCT ID: NCT03147222

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2019-12-12

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.

Conditions

Fractures, Bone; Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Fracture Care at Home

A trained FFC coach will visit each caregiver and fracture participant in the home for a 1-2 hour session once a week for 8 weeks.

Group Type: EXPERIMENTAL

Fracture Care at Home

Intervention Type: BEHAVIORAL

This is a graduated, functionally-based intervention, paired with caregiver interactions for enhancing functional abilities. Caregivers are encouraged to have the fracture participant actively participate in their own activities of daily living and incorporate functional activities into daily routines. An intervention coach will discuss care related challenges with the caregiver to identify dependency problems, motivate the caregiver to help foster independence in the care recipient, and provide guidance in addressing behavioral symptoms associated with cognitive limitation that may occur during caregiving. The coach is guided by interventions designed by PTs, OTs, and a nurse practitioner expert in FFC. The intervention includes 1) initial assessment of participant, caregiver, and environment, 2) coaching and mentoring of caregivers regarding use of effective motivational strategies, 3) goal setting, and 4) on-going motivation and evaluation.

Interventions

Fracture Care at Home

This is a graduated, functionally-based intervention, paired with caregiver interactions for enhancing functional abilities. Caregivers are encouraged to have the fracture participant actively participate in their own activities of daily living and incorporate functional activities into daily routines. An intervention coach will discuss care related challenges with the caregiver to identify dependency problems, motivate the caregiver to help foster independence in the care recipient, and provide guidance in addressing behavioral symptoms associated with cognitive limitation that may occur during caregiving. The coach is guided by interventions designed by PTs, OTs, and a nurse practitioner expert in FFC. The intervention includes 1) initial assessment of participant, caregiver, and environment, 2) coaching and mentoring of caregivers regarding use of effective motivational strategies, 3) goal setting, and 4) on-going motivation and evaluation.

Intervention Type: BEHAVIORAL

Other Intervention Names

Function Focused Care (FFC) for the Cognitively Impaired

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

• 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

• 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

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Ann Gruber-Baldini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Gruber-Baldini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1R21AG054143-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00072220

Identifier Type: -

Identifier Source: org_study_id