I-HoME for Caregiver Burden

Overseen By Veerawat Phongtankuel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-English speaking, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called I-HoME, which uses video visits with a nurse practitioner to assist family caregivers in managing the care and symptoms of loved ones with advanced Alzheimer's Disease or related dementia. The goal is to determine if this approach is practical and helpful for caregivers. Participants should be English-speaking adults caring for someone with advanced dementia symptoms. As an unphased trial, this study offers caregivers a unique opportunity to explore innovative support methods.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the I-HoME intervention is safe for family caregivers?

Research on the I-HoME intervention remains in the early stages, so specific safety data is not yet available. However, this intervention involves video calls with a nurse practitioner, which generally poses low risk. It focuses on managing symptoms and care needs through conversation and guidance. Since I-HoME is neither a drug nor a medical procedure, the risk of side effects is much lower compared to other treatments. Participants can expect a safe and supportive environment designed to help them manage caregiving challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

I-HoME is unique because it offers a personalized approach to managing caregiver burden through video visits with a nurse practitioner. Unlike traditional methods that often rely on in-person consultations, this treatment provides flexibility and convenience by allowing caregivers to receive support and guidance from home. Researchers are excited about this method because it could improve access to care, reduce stress for caregivers, and tailor interventions to specific needs, potentially leading to better outcomes for both caregivers and those they care for.

What evidence suggests that the I-HoME intervention is effective for reducing caregiver burden in advanced Alzheimer's Disease?

Initial findings suggest that the I-HoME program, which participants in this trial will receive, could help reduce stress for caregivers of patients with advanced Alzheimer's disease and related dementia. Research has shown that caregivers often experience anxiety and depression, with about 28.60% facing these mental health issues. I-HoME includes video calls with a nurse practitioner to help manage symptoms and care needs. By addressing these challenges, the program aims to reduce caregiver stress, potentially improving their mental health and quality of life. ^{2 3 4 6 7}

Who Is on the Research Team?

Veerawat Phongtankuel, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for family caregivers of patients with advanced Alzheimer's Disease and related dementias. It aims to support them in managing end-of-life issues using a technology-based intervention called I-HoME.

Inclusion Criteria

English speaking

I care for someone over 65 with advanced dementia, rated 7a-f on the FAST scale.

Exclusion Criteria

Non-English speaking

I am between 18 and 100 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs

12 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in caregiver anxiety, burden, perception of patient's pain, and behavioral symptoms of dementia

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• I-HoME

Trial Overview The study is testing the I-HoME intervention, which uses technology to help caregivers manage end-of-life care challenges for dementia patients. The focus is on assessing how feasible and acceptable this approach is for participants.

How Is the Trial Designed?

Group I: Intervention (I-HoME) Experimental Treatment 1 Intervention

Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

This study analyzed caregiver burden using a large national sample of 409 caregivers, revealing that factors like the caregiver's gender, their relationship to the patient, and the patient's living situation significantly influence the level of burden experienced.

The research identified specific correlates of caregiver burden, with variance explained ranging from 25% for husbands living with patients to 68% for husbands with spouses in nursing homes, highlighting the need for tailored interventions based on caregiver circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wives, husbands, and daughters caring for institutionalized and noninstitutionalized dementia patients: toward a model of caregiver burden. Harper, S., Lund, DA.[2017]

Family caregivers of people with dementia experience significant burdens, and transitioning care from home to nursing homes or outpatient group living does not fully alleviate these challenges, as shown in a study of 314 caregivers.

While some physical complaints improve with different care settings, the psychological burdens remain higher for home caregivers compared to those in nursing homes or outpatient care, indicating that issues persist regardless of the care environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Caregiver's burden of caring for patients with dementia in group living compared to to domestic and inpatient care]. Reggentin, H.[2019]

The In-Home pilot program, which involved 22 home care offices, enabled caregivers to report changes in care recipients' conditions after 2% of shifts, potentially helping to manage health issues at home and avoid hospitalizations.

Caregivers and care managers generally had positive attitudes towards the intervention, although challenges included staff resistance to change and the need for a flexible approach to meet diverse patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Data on a Care Coordination Program for Home Care Recipients. Dean, KM., Hatfield, LA., Jena, AB., et al.[2018]

In a study of 68 medically complex patients with special health-care needs, caregiver burden was significantly associated with having older siblings, indicating that family dynamics can impact the stress experienced by caregivers.

For patients aged 15 years and older, caregiver burden was notably higher for those requiring home mechanical ventilation with tracheostomy, while having younger siblings appeared to reduce caregiver burden, highlighting the importance of both medical needs and family structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factor-associated caregiver burden in medically complex patients with special health-care needs. Yotani, N., Ishiguro, A., Sakai, H., et al.[2016]

Caregivers of elderly individuals with behavioral disturbances reported feeling a significantly heavier burden, highlighting the impact of the elderly's condition on caregiver stress.

Access to respite services is crucial; caregivers who had temporary relief from caregiving duties felt less burdened, suggesting that improving the availability and convenience of these services could alleviate caregiver stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors related to feelings of burden among caregivers looking after impaired elderly in Japan under the Long-Term Care insurance system. Arai, Y., Kumamoto, K., Washio, M., et al.[2022]

In a study of 430 home care patients in Ontario, Canada, 19.2% experienced adverse events (AEs), with a notable incidence rate of 13.2%, indicating that many patients face risks while receiving care at home.

About one-third of the identified AEs were deemed preventable, highlighting the need for better education and planning for patients and caregivers to reduce these incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of adverse events among home care patients. Sears, N., Baker, GR., Barnsley, J., et al.[2022]

A survey of 342 family caregivers of cancer patients in Japan revealed that caregivers of patients with moderate care needs experienced the highest time-dependent burden, indicating that the level of care required significantly impacts caregiver stress.

Younger caregivers and older patients were also found to be at greater risk for experiencing this burden, suggesting that both patient and caregiver characteristics should be considered to improve care service balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care needs level in long-term care insurance system and family caregivers' self-perceived time-dependent burden in patients with home palliative care for cancer: a cross-sectional study. Otsuki, N., Yamamoto, R., Sakaguchi, Y., et al.[2022]

A study involving 70 family caregivers of impaired elderly individuals revealed that emotional and mental strain from caregiving is a more significant burden than physical or financial challenges.

Caregivers expressed a strong need for better access to information, personal counseling, and increased support during evenings, nights, and weekends to alleviate their burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Burden and possibility of respite for family caregivers]. Bösch, J., Rothlin, S., Trüllinger, E.[2019]

A study conducted on caregivers of psychiatric patients in India found that working women experience a significantly higher caregiver burden compared to homemakers, with mean scores of 55.66 for homemakers and 58.16 for working women.

The research highlights the need for targeted support for working women caregivers, as they face greater physical, psychological, and emotional challenges while caring for individuals with conditions like schizophrenia and bipolar affective disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver burden among working women and homemakers taking care of psychiatric patients. Kaur, N., Puria, A., Kumar, A., et al.[2022]

In a study of 231 patients receiving hospital-in-the-home (HIH) care, the rate of adverse events was low, with only 3.5% experiencing iatrogenic complications, indicating that HIH care is a safe alternative to traditional hospitalization.

The study found that 4.2% of patients required a return to the hospital during their HIH admission, and 2.2% returned within 14 days of discharge, suggesting that while HIH care is generally safe, there are still some risks that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe is hospital-in-the-home care? Montalto, M.[2020]

Adverse events in hospital nursing units are linked to increased burnout among nurses, indicating that these incidents have broader negative impacts beyond just the patients involved.

The relationship between adverse events and nurse burnout is stronger when nurses have a high sense of workgroup identification, but this effect can be reduced if the safety climate in the workplace is perceived as positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events and Burnout: The Moderating Effects of Workgroup Identification and Safety Climate. Vogus, TJ., Ramanujam, R., Novikov, Z., et al.[2021]

A community and hospital-based partnership intervention significantly improved caregiver satisfaction with home services after 6 months, compared to routine home visits, involving 109 caregivers in the experimental group and 101 in the control group.

While the intervention reduced caregiver satisfaction, it did not significantly decrease the overall care burden, suggesting that additional support measures may be necessary to alleviate caregiver stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of a mental health home visit service partnership intervention on the caregivers' home visit service satisfaction and care burden. Cheng, JF., Huang, XY., Lin, MJ., et al.[2018]

In a study of 47 patients receiving home health care, 40.4% experienced falls within a 3-month period, indicating a significantly higher incidence of falls compared to the general elderly population.

The research found no significant causal relationship between caregiver burden and the occurrence of falls, suggesting that other factors may contribute to fall risk in home health care patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of the relationship between patient falls and caregiver burden in home health care: A pilot study. Cho, T., Nakajima, T., Ueno, Y., et al.[2022]

The study of 215 caregivers in Valencia revealed that a significant number experience psychological distress, with 32% showing anxiety and 22% showing depression, particularly linked to the patient's physical dependence and mental deterioration.

Caregiver strain was notably high in 11% of participants, indicating that support for caregivers is essential and should be integrated into patient care strategies to improve overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Profile and risk of mental illness in caregivers for home care patients]. Moral Serrano, MS., Juan Ortega, J., López Matoses, MJ., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11121359/

Exploring Factors Influencing Caregiver Burden This study aimed to systematically review and analyze factors contributing to caregiver burden among family caregivers of older adults with chronic illnesses ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2950307825000785

Prevalence of depression, anxiety, burden, burnout, and ... Specifically, caregiving has been linked to significantly higher rates of anxiety and depression, with one study in Canada reporting that approximately 28.60% ...

3. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-29-2024/number-3-september-2024/articles-on-previously-published-topics/caregiver-burden/

Caregiver Burden and Mental Health: Millennial Caregivers Research has shown that caregivers of family members with mental illness have an increased incidence of depression, anxiety, and sleep disorders.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988590/

Stress as a Risk Factor for Informal Caregiver Burden - PMC This study examined the connections between anxiety, depression, stress, and caregiver burden in informal caregivers.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-18321-3

The impact of caregiver burden on quality of life in family ... This study aims to probe the mediating effect of psychological distress on the relationship between caregiver burden and QoL, as well as the moderating effect ...

6. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7334a2.htm

Changes in Health Indicators Among Caregivers This report compares changes in the prevalence of 19 health indicators among caregivers and noncaregivers from 2015–2016 to 2021–2022.

7. ourparents.com ourparents.com/senior-health/caregiver-burnout-statistics

Caregiver Burnout and Stress: 2023 Statistics and Trends As much as 60% of caregivers suffer from some level of emotional stress, which can lead to caregiver burnout, depression, and other health issues.