Function Focused Care: Fracture Care at Home

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147222
• Other study ID #: HP-00072220
• Secondary ID: 1R21AG054143-01
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: December 12, 2019

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Fractures, Bone

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Environment for Impact on Physical Activity	Assessment of Environment for Impact on Physical Activity is a visual checklist indicating whether the described environmental component is present or absent. This measure will be included at baseline to tailor the intervention, but will be repeated at follow-up as a potential intermediate outcome. Environment assessments will be done by the FFC coach and recommendations for change discussed with caregiver and initiated as approved. Additionally, changing the environment to optimize function and physical activity (e.g., providing access to open areas for walking, pleasant destinations, and rest areas along pathways) will also facilitate the integration of the Hip Care at Home intervention.	3 weeks and 6 weeks after the start of the intervention
Other	Goal Attainment	Knowledge from the environment, caregiver beliefs/culture of the home environment, and the Physical Capability Assessment will be used to set goals. Up to four fracture participant goals are listed on the Goal Attainment Scale and then scored on their progress where scores can range from -8 to 8 with score of 0 indicating expected progress and positive score indicates greater than expected progress. This measure will be included at baseline to tailor the intervention, but will be repeated at follow-up as a potential intermediate outcome.	3 weeks and 6 weeks after the start of the intervention
Other	Care Goal Identification	The Care Goal Identification Form is a 3 part form used to identify problems, goals to address those problems, and ways to incorporate technology into the solutions. This measure will be included at baseline to tailor the intervention, but will be repeated at follow-up as a potential intermediate outcome.	3 weeks and 6 weeks after the start of the intervention
Primary	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
Primary	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	Physical Activities of Daily Living (PADLs) - fracture participant outcome	Physical activities of daily living (PADLs) assess the fracture participant's receipt of assistance in 15 PADLs with an instrument whose structure is similar to Jette's Functional Status Index and incorporates activities from the Older Americans Resources and Services (OARS) Instrument PADL scale and those used by Cummings et al.	8 weeks
Secondary	Instrumental Activities of Daily Living (IADLs) - fracture participant outcome	Instrumental activities of daily living (IADLs) are measured by 7 items from the OARS.	8 weeks
Secondary	Short Physical Performance Battery (SPPB) - fracture participant outcome	Short Physical Performance Battery (SPPB) will be used to assess timed physical performance of balance, gait, strength, and endurance. Walking speed over 3 meters and a single timed chair rise without using arms will also be assessed.	8 weeks
Secondary	MotionWatch to Monitor Physical Movement - fracture participant outcome	A MotionWatch manufactured by CamNtech Ltd., a compact, lightweight, body-worn activity monitoring device, will be placed on the wrist of the fracture participant at each measurement interview (baseline and follow-up) and removed 5 days later by study personnel. The MotionWatch is intended to monitor limb or body movements during daily living and sleep and may be used to document physical movement associated with applications in physiological monitoring.	8 weeks
Secondary	Modified Mini-Mental State Examination (3MS) - fracture participant outcome	Global cognition will be assessed using the Modified Mini-Mental State Examination (3MS), which also be used to describe severity of ADRD. This measure will be used to describe the extent of the cognitive impairment in people with ADRD in the sample and selecting a comparison group from existing data.	8 weeks
Secondary	Neuropsychiatric Inventory (NPI) - fracture participant outcome	Behavioral and affective outcomes will examine the impact on caregiver rated behavioral symptoms of ADRD using the Neuropsychiatric Inventory (NPI), which includes items on 10 behavioral disturbances: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. These are all rated by the caregiver.	8 weeks
Secondary	Cornell Scale for Depression in Dementia (CSDD) - fracture participant outcome	The Cornell Scale for Depression in Dementia (CSDD) was specifically developed to assess signs and symptoms of major depression in patients with dementia. Caregivers will be interviewed on each of the 19 items on the scale and instructed to base her/his report on observations of the fracture participant's behavior during the week prior to the interview.	8 weeks
Secondary	Adverse Events	Falls and other adverse events, including hospitalization, nursing home placement, and death will be recorded throughout the study.	8 weeks
Secondary	Improvement in Knowledge of FFC - caregiver outcome	Knowledge of FFC will be assessed using the Knowledge of Function and Behavior Focused Care Activities Test after the information is presented and again at end of study.	2 weeks and 8 weeks after the start of the intervention
Secondary	Self-Efficacy for Functional and Physical Activities - caregiver outcome	Self-Efficacy for Functional and Physical Activities is a 10-question survey to the caregiver about their confidence in their ability to encourage the hip fracture participant to undertake difference activities of daily living independently. Responses are either 'Yes' or 'No'.	8 weeks
Secondary	Outcomes Expectations for Function and Physical Activity - caregiver outcome	Outcomes Expectations for Function and Physical Activity is a 9-item survey given to caregivers about the extent to which they agree that with statements about caregiving and care recipient independence.	8 weeks
Secondary	Improvement in Performance of FFC - caregiver outcome	Performance of FFC care will be assessed using the Function Focused Care Behavior Checklist. Observations will be done by the FFC coach in the home setting as part of the regular weekly intervention visits at 3 weeks and 6 weeks after the start of intervention. Immediate feedback will be provided to the caregiver following the observed care interactions (e.g., positive reinforcement for function focused care will be provided or information about missed opportunities for function focused care to be provided) and the FFC coach will work toward immediate increased integration of the recommended interventions during routine care.	3 weeks and 6 weeks after the start of the intervention
Secondary	Zarit Burden Interview - caregiver outcome	Caregiver burden will be assessed using the Zarit Burden Interview, a 22-item scale answered by caregivers, response options ranging from 0 (Never) to 4 (Nearly Always). Factors capture personal strain and role strain.	8 weeks
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D) - caregiver outcome	Caregiver depressive symptoms will be measured using the 20-item version of the Center for Epidemiologic Studies Depression Scale (CES-D). Possible scores range from 0-60.	8 weeks
Secondary	Falls Efficacy Scale International (FES-I)	The Falls Efficacy Scale International (FES-I) will be used to assess fear of falling in fracture participants and fear of falling in caregivers for themselves and their care recipients.	8 weeks