Fractures, BoneNCT03147222
Function Focused Care: Fracture Care at Home
A study testing Fracture Care at Home in people with Fractures, Bone and Dementia, run by University of Maryland, Baltimore at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fractures, Bone, Dementia
- What is being tested?
- Fracture Care at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- CAREGIVER PARTICIPANTS
- Not English speaking
- Living more than 40 miles from the hip fracture participant
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hip Fracture Caregiver Intervention - Function Focused Care: Fracture Care at Home
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.
Read the 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
- Being tested
- Fracture Care at Home
- Keywords
- fragility fracture, dementia, intervention
- Medical subject headings
- Fractures, Bone, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture Care at HomeBehavioural
Also called Function Focused Care (FFC) for the Cognitively Impaired
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fracture Care at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (15)
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.
Measured: 8 weeks
Instrumental Activities of Daily Living (IADLs) - fracture participant outcome
Instrumental activities of daily living (IADLs) are measured by 7 items from the OARS.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Adverse Events
Falls and other adverse events, including hospitalization, nursing home placement, and death will be recorded throughout the study.
Measured: 8 weeks
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.
Measured: 2 weeks and 8 weeks after the start of the intervention
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'.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 3 weeks and 6 weeks after the start of the intervention
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start26 Sep 2018
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ann Gruber-Baldini, University of Maryland, Baltimore
- Investigators
- Ann Gruber-Baldini, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147222
- Sponsor's protocol ID
- HP-00072220
- Other IDs
- 1R21AG054143-01
- Status last verified
- Feb 2022
- First submitted
- 3 May 2017
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Caregiver Intervention - Function Focused Care: Fracture Care at Home
- ClinicalTrials.gov ID
- NCT03147222
- Acronym / sponsor ID
- HP-00072220
- Conditions
- Fractures, Bone, Dementia
- Keywords
- fragility fracture, dementia, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Fracture Care at Home | Experimental | Behavioral: Fracture Care at HomeA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fracture Care at HomeAlso: Function Focused Care (FFC) for the Cognitively ImpairedThis 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. | Behavioural | Fracture Care at Home |
Primary outcome
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.
15 secondary outcomes
Physical Activities of Daily Living (PADLs) - fracture participant outcome
Time frame: 8 weeks
Instrumental Activities of Daily Living (IADLs) - fracture participant outcome
Time frame: 8 weeks
Short Physical Performance Battery (SPPB) - fracture participant outcome
Time frame: 8 weeks
MotionWatch to Monitor Physical Movement - fracture participant outcome
Time frame: 8 weeks
Modified Mini-Mental State Examination (3MS) - fracture participant outcome
Time frame: 8 weeks
Neuropsychiatric Inventory (NPI) - fracture participant outcome
Time frame: 8 weeks
Cornell Scale for Depression in Dementia (CSDD) - fracture participant outcome
Time frame: 8 weeks
Adverse Events
Time frame: 8 weeks
Improvement in Knowledge of FFC - caregiver outcome
Time frame: 2 weeks and 8 weeks after the start of the intervention
Self-Efficacy for Functional and Physical Activities - caregiver outcome
Time frame: 8 weeks
Outcomes Expectations for Function and Physical Activity - caregiver outcome
Time frame: 8 weeks
Improvement in Performance of FFC - caregiver outcome
Time frame: 3 weeks and 6 weeks after the start of the intervention
Zarit Burden Interview - caregiver outcome
Time frame: 8 weeks
Center for Epidemiologic Studies Depression Scale (CES-D) - caregiver outcome
Time frame: 8 weeks
Falls Efficacy Scale International (FES-I)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Gruber-Baldini, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture Care at Home in people with Fractures, Bone and Dementia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.