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

15 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment I-HoME for reducing caregiver burden?

The In-Home care coordination program showed promise in reducing avoidable hospitalizations, which could indirectly lessen caregiver burden by managing health issues at home. Additionally, a mental health home visit service partnership improved caregiver satisfaction and reduced their burden, suggesting that similar home-based interventions like I-HoME might be effective. ^{1 2 3 4 5}

Is I-HoME safe for caregivers?

Research on hospital-in-the-home care, which is similar to I-HoME, shows that there can be negative and unexpected events, but these studies help identify safety indicators to improve care. While specific safety data for I-HoME isn't available, understanding these risks can help ensure safer care environments. ^{4 6 7 8 9}

How does the I-HoME treatment differ from other treatments for caregiver burden?

The I-HoME treatment is unique because it focuses on providing more and better information, personal counseling, and increased support during evenings, nights, and weekends, which are times when caregivers often feel the most burdened. This approach addresses the emotional and informational needs of caregivers, which are not typically the focus of other treatments. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to pilot test the adapted Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention with family caregivers of patients with advanced Alzheimer's Disease and related dementia. Data will be collected regarding intervention feasibility and acceptability.

Research Team

Veerawat Phongtankuel, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

I am between 18 and 100 years old.

Non-English speaking

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Preliminary Data on a Care Coordination Program for Home Care Recipients. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Factor-associated caregiver burden in medically complex patients with special health-care needs. [2016]

4. Spain pubmed.ncbi.nlm.nih.gov

[Profile and risk of mental illness in caregivers for home care patients]. [2020]

5. England 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. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

How safe is hospital-in-the-home care? [2020]

7. England pubmed.ncbi.nlm.nih.gov

The incidence of adverse events among home care patients. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Prospective study of the relationship between patient falls and caregiver burden in home health care: A pilot study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Events and Burnout: The Moderating Effects of Workgroup Identification and Safety Climate. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Burden and possibility of respite for family caregivers]. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

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

12. India pubmed.ncbi.nlm.nih.gov

Caregiver burden among working women and homemakers taking care of psychiatric patients. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. Australia 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. [2022]