Enhanced Home Rehabilitation Therapy for Elderly Care

Overseen By Chiung-ju Liu, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Cancer, Dialysis, Cardiac surgery, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to enhance home health care for seniors by adding a special program focused on daily activities to the usual home health rehabilitation therapy. The goal is to determine if this helps patients perform better at home. The trial seeks participants aged 65 and older who are on Medicare and require rehab services at home, particularly those with three or more health issues. Participants will receive either the special program alongside their regular care or just the regular care to compare results. As an unphased trial, this study provides a unique opportunity for seniors to contribute to innovative approaches in home health care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ADL-enhanced program is safe for elderly care?

Research has shown that treatments focusing on daily activities are generally safe and beneficial. These programs can help older adults maintain or even improve their physical abilities, quality of life, and independence. Participants in similar therapies have reported improvements without major side effects, indicating these treatments are well-tolerated.

Although the specific ADL-enhanced program hasn't been directly tested for safety, its components are commonly used and usually considered safe. The trial's "Not Applicable" phase suggests that safety is not the main concern, reflecting confidence in the treatment's safety based on previous research and similar therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Home Rehabilitation Therapy for elderly care because it offers a novel approach to improving daily living activities through an ADL-enhanced program. Unlike standard home health care rehabilitation, this experimental treatment includes six home visits by an occupational therapist, which aims to deliver more personalized and intensive support. This tailored approach could potentially enhance recovery and improve the quality of life for elderly patients by focusing more closely on specific activities of daily living, setting it apart from usual care methods.

What evidence suggests that the ADL-enhanced program is effective for improving patient outcomes in elderly care?

Research has shown that incorporating everyday activities into home rehab programs can significantly enhance recovery. In this trial, participants in the experimental arm will receive the ADL-enhanced program in addition to standard home health care rehabilitation. For instance, one study found that patients improved in movement and self-care skills. Another study noted enhanced cognitive abilities, using assessments like the Barthel Index and Mini-Mental State Examination. Further research suggests that structured home rehab can boost both physical and mental health. These findings support the notion that integrating everyday activities into home care can lead to improved recovery outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Chiung-ju Liu, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who are Medicare beneficiaries and referred for skilled rehabilitation services. They must have at least three comorbidities but cannot join if they have acute fractures, terminal heart failure, ongoing dialysis, recent stroke or major neurological issues, joint replacement surgery, limb amputation, active cancer treatment, hospice care referral or severe cognitive deficits.

Inclusion Criteria

Patients have three or more comorbidities

I am covered by Medicare.

I am 65 years old or older.

Exclusion Criteria

Patients are in the terminal stage of congestive heart failure

I have had an amputation of part of my leg.

I have been referred to hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ADL-enhanced program and usual home health care rehabilitation

6 weeks

6 home visits (in-person)

Follow-up

Participants are monitored for self-care and physical performance outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ADL-enhanced program
• Usual home health rehabilitation therapy

Trial Overview The study is testing an ADL-enhanced program alongside usual home health rehabilitation to see if it improves outcomes in elderly patients. Participants will be randomly assigned to receive either the enhanced program plus usual care or just the usual care alone.

How Is the Trial Designed?

Group I: Experimental arm Experimental Treatment 2 Interventions

Research participants in this arm will receive the ADL-enhanced program and usual home health care rehabilitation. The ADL-enhanced program consists of six home visits delivered by a study occupational therapist.

Group II: Control arm Experimental Treatment 1 Intervention

Research participants in this arm will receive usual home health care rehabilitation.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38803998/

Age-Related Differences in the Effectiveness of ... This study aimed to reveal differences in the effectiveness of rehabilitation in improving activities of daily living (ADL) in patients with acute stroke ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215002/

Evaluation of Activities of Daily Living: Current Insights and ... The results showed significant improvements in motor function, self-care ability (Barthel Index), and cognitive function (Mini-Mental State Examination) in the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859225004036

Effectiveness of a Structured Online Rehabilitation ... This study evaluated the efficacy of a structured online rehabilitation program in enhancing functional performance among older adults, compared ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024113825

Health-related outcomes of structured home-based ... The implementation of structured home-based rehabilitation programs may contribute to improve physical and psychological health-related outcomes among older ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05411393?term=AREA%5BBasicSearch%5D(rehabilitation)%20AND%20AREA%5BLocationSearch%5D(United%2BStates)%20AND%20AREA%5BStudyFirstPostDate%5D%20RANGE%5B2020-02-06,MAX%5D&rank=4

Synergizing Home Health Rehabilitation Therapy | ... Researchers will compare outcomes in self-care activities and physical performance between the two groups to determine the effect of the ADL-enhanced program.

6. withpower.com withpower.com/trial/phase-functional-status-7-2022-34be0

Enhanced Home Rehabilitation Therapy for Elderly Care Trial Overview The study is testing an ADL-enhanced program alongside usual home health rehabilitation to see if it improves outcomes in elderly patients.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0197457224002891

Maintaining daily living activities in older adults: The impact ... Following the intervention, participants significantly maintained ADL ability, improved physical performance and quality of life, and reduced frailty (all p < ...

8. qualityinsights.org qualityinsights.org/nursing-home-insights/adl-activities

ADL Activities: How They Impact Care and Quality Measures Therapy supports independence, improves quality of life, and can sometimes enable a safe return home. Restorative Nursing Programs (RNPs) and ...