Function Focused Care: Fracture Care at Home

NCT03147222 | Completed DMC

• 2 other identifiers: HP-000722201R21AG054143-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures, Bone; Dementia

Keywords

fragility fracture; dementia; intervention

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Intervention

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

  8 weeks

• Treatment Fidelity

  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.

  8 weeks

Secondary Outcomes (15)

• Physical Activities of Daily Living (PADLs) - fracture participant outcome

  8 weeks

• Instrumental Activities of Daily Living (IADLs) - fracture participant outcome

  8 weeks

• Short Physical Performance Battery (SPPB) - fracture participant outcome

  8 weeks

• MotionWatch to Monitor Physical Movement - fracture participant outcome

  8 weeks

• Modified Mini-Mental State Examination (3MS) - fracture participant outcome

  8 weeks

Other Outcomes (3)

• Assessment of Environment for Impact on Physical Activity

  3 weeks and 6 weeks after the start of the intervention

• Goal Attainment

  3 weeks and 6 weeks after the start of the intervention

• Care Goal Identification

  3 weeks and 6 weeks after the start of the intervention

Study Arms (1)

Fracture Care at Home

EXPERIMENTAL

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.

Behavioral: Fracture Care at Home

Interventions

Fracture Care at Home 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.

Also known as: Function Focused Care (FFC) for the Cognitively Impaired

Fracture Care at Home

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Dementia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ann Gruber-Baldini, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will receive the intervention.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 10, 2017
• Study Start: September 26, 2018
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)