DementiaNCT04235374
Implementation of Function Focused Care in Acute Care
A study testing FFC-AC-EIT in people with Dementia and Acute Medical Event, run by University of Maryland, Baltimore at 14 sites in United States.
Trial summary
Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia, Acute Medical Event, Hospitalization
- What is being tested?
- FFC-AC-EIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 455 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Oct 2020to 14 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are admitted into the hospital from any setting during the 12 month implementation period;
- are 55 years of age or older;
- are admitted onto a medical unit for any medical diagnosis; and
- screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of >2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).
Who cannot join
- are enrolled in Hospice;
- have been on the unit for greater than 48 hours;
- do not have a family member/caregiver that we can contact;
- anticipate surgery; or
- have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Jefferson Abbington
Abington, Pennsylvania, 19001
Luminus Anne Arundel Medical Center
Annapolis, Maryland, 21401
University of Maryland Baltimore Washington Medical Center
Baltimore, Maryland, 21201
University of Maryland Hospital
Baltimore, Maryland, 21201
Midtown Hospital
Baltimore, Maryland, 21211
University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
Lancaster Hospital
Lancaster, Pennsylvania, 17602
Jefferson Lansdale
Lansdale, Pennsylvania, 19446
University of maryland Upper Chesapeake Hospital
Perryville, Maryland, 21903
Jefferson Lansdale (control);
Philadelphia, Pennsylvania, 16802
Hospital University of Pennsylvania - Cedar Avenue
Philadelphia, Pennsylvania, 19143
Jefferson Methodist
Philadelphia, Pennsylvania, 19148
University of Maryland Saint Joseph Medical Center
Towson, Maryland, 21204
Chester County Hospital
West Chester, Pennsylvania, 19380
About this study
Official title: Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias
Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.
Read the detailed description
After hospitals are recruited they will be randomized to cohort and randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder team and unit champions for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months. Timing of the intervention activities will be flexible based on the needs of the unit. The first meeting with the stakeholder team will be 1-2 hours and the remaining meetings will be approximately 30 minutes monthly to update the stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT. The majority of the time on the unit by the Research Nurse Facilitator will be spent with the champions helping and assuring that they are engaging staff in function focused care activities via the four steps of FFC-AC-EIT. Once hospitals are randomized we will set up a time to meet with the identified contact to determine the stakeholder team members and champions and organize the first stakeholder team meeting. The first meeting will provide an overview of the implementation of Steps 1 to 4 [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families] and will address the unit challenges to implementing function focused care using a Brainstorming approach. In the first two months the Research Nurse Facilitator completes the environment and policy assessments with the champions and implements appropriate changes on the units and plans and provides staff education and makes available information for patients and families/ caregivers. The education reviews function focused care. Ongoing work between the champions and the Research Nurse Facilitator focuses on motivating staff and patients to work toward achievement of patient goals and established unit goals. The stakeholder team will continue to meet with the Research Nurse Facilitator monthly (approximately 30 minutes) over the 12-month intervention period to review progress and to help champions overcome any identified multilevel challenges. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. To further facilitate implementation we will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion to attend a conference and submit an abstract focused on optimizing function and physical activity of hospitalized older adults with ADRD. Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
- Conditions
- Dementia, Acute Medical Event, Hospitalization
- Being tested
- FFC-AC-EIT
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFC-AC-EITBehavioural
Also called FFC-AC-EO
The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
| Study group | Role | What they receive |
|---|---|---|
| FFC-AC-EIT | Experimental | The stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of FFC-AC-EIT [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. Receives: Behavioral: FFC-AC-EIT |
| Education Only | Placebo comparator | Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice. Receives: Behavioral: FFC-AC-EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Barthel Index
A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
Measured: Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge
The Physical Activity Survey
The Physical Activity Survey is a subjective measure of time spent in physical activities over 24 hours based on input from an informant. A total of 37 activities iin the following areas are included: locomotion (e.g., walking, wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and occupational therapy), recreational activity (music), and repetitive behavior (moving objects repeatedly). scores range from 0 to 37 with each activity considered as done at least once during the day. Higher scores are indicative of more physical activities done.
Measured: Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post discharge
The Short Confusion Assessment Method
An assessment for evidence of delirium based on items reflective of behaviors associated with delirium. There are four areas considered: Acute onset and fluctuating course is scored as no (0) or yes (1). Inattention and disorganized thinking are each scored as "absent" (0 points), present in mild form (1 point), or present in severe form (2 points). Altered level of consciousness, is scored as alert or normal (0 points), vigilant or lethargic (1 point), and stupor or coma (2 points). Scores range from 0-7, with a higher score indicating greater severity of delirium.
Measured: baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post discharge
the Brief Neuropsychiatric Inventory
Assessment of behavioral symptoms including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating is done. The presence of each behavior is scored as present (1) or not present (0). The behaviors are then scored and range from 0 to 12. Higher scores are indicative of more behavioral and psychological symptoms associated with dementia.
Measured: baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nb
Pain in Advanced Dementia Scale (PAINAD)
An objective measure of 5 behaviors commonly associated with pain. Each pain behavior is scored from 0 (no evidence) to 2 (persistant behavior). Scores are then summed for a total score that ranges from 0 to 10 with higher scores indicative of more pain.
Measured: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start19 Oct 2020
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Penn State University
- Responsible party
- Principal investigator, Barbara Resnick, University of Maryland, Baltimore
- Investigators
- Barbara Resnick, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235374
- Sponsor's protocol ID
- 00089301
- Other IDs
- R01AG065338-01
- Status last verified
- Jul 2025
- First submitted
- 15 Jan 2020
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Resnick B, Boltz M, Galik E, Kuzmik A, McPherson R, Drazich B, Kim N, Zhu S, Wells CL. Measurement of Physical Activity Among Hospitalized Older Adults Living With Dementia. Rehabil Nurs. 2024 Jul-Aug 01;49(4):115-124. doi: 10.1097/RNJ.0000000000000464. Epub 2024 Jun 20.
PubMed 38904657
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT04235374
- Acronym / sponsor ID
- 00089301
- Conditions
- Dementia, Acute Medical Event, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Penn State University
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults with Alzheimer's Disease and Related Dementias (ADRD) comprise approximately 25% of hospitalized older adults. These individuals are at increased risk for functional decline, delirium, falls, behavioral symptoms associated with dementia (BPSD) and longer lengths of stay. Physical activity during hospitalization (e.g., mobility,bathing, dressing) has a positive impact on older adults including prevention of functional decline, less pain, less delirium, less BPSD, fewer falls, shorter length of stay and decreased unplanned hospital readmissions. Despite known benefits, physical activity is not routinely encouraged and older hospitalized patients spend over 80% of their acute care stay in bed. Challenges to increasing physical activity among older patients with ADRD include environment and policy issues (e.g., lack of access to areas to walk); lack of knowledge among nurses on how to evaluate, prevent and manage delirium and BPSD; inappropriate use of tethers; beliefs among patients, families, and nurses that bed rests helps recovery and prevents falls; and lack of motivation/willingness of patients to get out of bed. To increase physical activity and prevent functional decline while hospitalized we developed Function Focused Care for Acute Care (FFC-AC-EIT) for patients with ADRD. Implementation of FFC-AC-EIT changes how care is provided by having nurses teach, cue, and help patients with ADRD engage in physical activity during all care interactions. FFC-AC-EIT was developed using a social ecological model, social cognitive theory and the Evidence Integration Triangle. It involves a four-step approach that includes: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families. The purpose of this study is to test the efficacy of FFC-AC-EIT within 12 hospitals in Maryland and Pennsylvania randomized to FFC-AC-EIT or Function Focused Care Education Only (EO) with 50 patients recruited per hospital (total sample 600 patients). Aim 1 will focus on efficacy at the patient level based primarily on physical activity, function, and participation in function focused care, and secondarily on delirium, BPSD, pain, falls, use of tethers, and length of stay; and all of these outcomes (except length of stay and tethers) along with emergency room visits, re-hospitalizations and new long term care admissions at 1, 6 and 12 months post discharge; and at the unit level the aim is to evaluate the impact of FFC-AC-EIT on policies and environments that facilitate function and physical activity at 6, 12 and 18 months post implementation. Hospitals randomized to FFC-AC-EIT will be compared with those randomized to Function Focused Care Education Only (EO). Aim 2 will evaluate the feasibility, based on treatment fidelity (delivery, receipt, enactment)136, and relative cost and cost savings of FFC-AC-EIT versus EO. Findings will address several prioritized areas of research: a focus on ADRD; improving physical function; and training of hospital staff and will demonstrate efficacy of an approach to care for patients with ADRD that can be disseminated and implemented across all acute care facilities.
Detailed description
After hospitals are recruited they will be randomized to cohort and randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder team and unit champions for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months. Timing of the intervention activities will be flexible based on the needs of the unit. The first meeting with the stakeholder team will be 1-2 hours and the remaining meetings will be approximately 30 minutes monthly to update the stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT. The majority of the time on the unit by the Research Nurse Facilitator will be spent with the champions helping and assuring that they are engaging staff in function focused care activities via the four steps of FFC-AC-EIT. Once hospitals are randomized we will set up a time to meet with the identified contact to determine the stakeholder team members and champions and organize the first stakeholder team meeting. The first meeting will provide an overview of the implementation of Steps 1 to 4 [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families] and will address the unit challenges to implementing function focused care using a Brainstorming approach. In the first two months the Research Nurse Facilitator completes the environment and policy assessments with the champions and implements appropriate changes on the units and plans and provides staff education and makes available information for patients and families/ caregivers. The education reviews function focused care. Ongoing work between the champions and the Research Nurse Facilitator focuses on motivating staff and patients to work toward achievement of patient goals and established unit goals. The stakeholder team will continue to meet with the Research Nurse Facilitator monthly (approximately 30 minutes) over the 12-month intervention period to review progress and to help champions overcome any identified multilevel challenges. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. To further facilitate implementation we will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion to attend a conference and submit an abstract focused on optimizing function and physical activity of hospitalized older adults with ADRD. Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized trial with treatment and control sites. Patients are followed for 12 months. Facilities are worked with for 12 months.
| Arm | Type | Receives |
|---|---|---|
| FFC-AC-EIT | Experimental | Behavioral: FFC-AC-EITThe stakeholder team will meet with the research nurse facilitator to review the details of the 12 month intervention and identify unit goals. The research nurse facilitator will then work with the identified champion for 10 hours weekly during months one and two and then for four hours weekly starting in month three for a total of 12 months to implement Steps 1 to 4 of FFC-AC-EIT [(1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff, Patients and Families]. The stakeholder team will meet with the Research Nurse Facilitator monthly to review progress. In addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all stakeholder team members within the cohort. The Tidbits include such things as updates about benefits of engaging patients with ADRD in physical activity while hospitalized. |
| Education Only | Placebo comparator | Behavioral: FFC-AC-EITEducation Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an in-service for nursing staff on function focused care in patients with ADRD by an EO Research Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is currently done in usual practice. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- are admitted into the hospital from any setting during the 12 month implementation period;
- are 55 years of age or older;
- are admitted onto a medical unit for any medical diagnosis; and
- screen positive for dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive Assessment (MoCA) and a score of >2 on the AD8 Dementia Screening Interview; have mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale (CDR); and lastly to differentiate between dementia and mild cognitive impairment eligibility is based on evidence of functional impairment with a score of 9 or greater on the Functional Activities Questionnaire (FAQ).
Key exclusion criteria (5 listed)
- are enrolled in Hospice;
- have been on the unit for greater than 48 hours;
- do not have a family member/caregiver that we can contact;
- anticipate surgery; or
- have a major acute psychiatric disorder, or significant neurological condition associated with cognition other than dementia.
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 |
|---|---|---|
| FFC-AC-EITAlso: FFC-AC-EOThe two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities. | Behavioural | Education Only, FFC-AC-EIT |
Primary outcome
The Barthel Index
Time frame: Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge
A measure of 10 activities of daily living with scores ranging from 0 to 100 and higher scores indicating better physical function.
The Physical Activity Survey
Time frame: Baseline (hospital admission), hospital discharge (approximately 3 days),1, 6, and 12 months post discharge
The Physical Activity Survey is a subjective measure of time spent in physical activities over 24 hours based on input from an informant. A total of 37 activities iin the following areas are included: locomotion (e.g., walking, wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and occupational therapy), recreational activity (music), and repetitive behavior (moving objects repeatedly). scores range from 0 to 37 with each activity considered as done at least once during the day. Higher scores are indicative of more physical activities done.
The Short Confusion Assessment Method
Time frame: baseline (hospital admission) ,hospital discharge (approximately 3 days), 1,6, and 12 months post discharge
An assessment for evidence of delirium based on items reflective of behaviors associated with delirium. There are four areas considered: Acute onset and fluctuating course is scored as no (0) or yes (1). Inattention and disorganized thinking are each scored as "absent" (0 points), present in mild form (1 point), or present in severe form (2 points). Altered level of consciousness, is scored as alert or normal (0 points), vigilant or lethargic (1 point), and stupor or coma (2 points). Scores range from 0-7, with a higher score indicating greater severity of delirium.
the Brief Neuropsychiatric Inventory
Time frame: baseline (hospital admission) , discharge (approximately 3 days),1,6, and 12 months post discharge nb
Assessment of behavioral symptoms including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating is done. The presence of each behavior is scored as present (1) or not present (0). The behaviors are then scored and range from 0 to 12. Higher scores are indicative of more behavioral and psychological symptoms associated with dementia.
Pain in Advanced Dementia Scale (PAINAD)
Time frame: change from baseline (hospital admission) to hospital discharge (approximately 3 days) date to change at 1,6, and 12 months post discharge
An objective measure of 5 behaviors commonly associated with pain. Each pain behavior is scored from 0 (no evidence) to 2 (persistant behavior). Scores are then summed for a total score that ranges from 0 to 10 with higher scores indicative of more pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38904657Resnick B, Boltz M, Galik E, Kuzmik A, McPherson R, Drazich B, Kim N, Zhu S, Wells CL. Measurement of Physical Activity Among Hospitalized Older Adults Living With Dementia. Rehabil Nurs. 2024 Jul-Aug 01;49(4):115-124. doi: 10.1097/RNJ.0000000000000464. Epub 2024 Jun 20.
- 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.
Barbara Resnick, PhD principal investigator
University of Maryland
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFC-AC-EIT in people with Dementia and Acute Medical Event, run by University of Maryland, Baltimore at 14 sites 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 4 inclusion and 5 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 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Barthel Index (time frame: Scores at hospital admission, hospital discharge, 1,6, and 12 months post discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235374, which also lists 1 linked publication.
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 5 Aug 2025.