Home Alone Program for Cognitive Impairment

Overseen By Joseph Gaugler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Psychotropics

Disqualifiers: Assisted living, Non-English, Mental health, others

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

Compensation: Varies

Number of Visits: 14

65 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate a program for adults who live alone and have some cognitive impairment (CI) to see if it is useful and acceptable. This program aims to help older adults with cognitive impairment who live alone to be engaged and active, as well as safe at home. The investigators want to see how useful this program is and how it can be improved. The specific aims are: * Specific Aim 1: Develop and Adapt Home Alone to Prepare for Pilot Testing. * Specific Aim 2: Pilot Test a Revised Version of Home Alone. Phase I participants will be asked to: * Participate for 3 months * Complete 3 surveys * Complete 7 1-hour meetings on a weekly basis with a coach * Complete a final interview Phase II participants will be asked to: * Participate for 6 months * Complete 3 surveys * Complete 7 1-hour meetings on a weekly basis with a coach * A sub-sample will be asked to complete a final interview

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dosage of psychotropic medications (like antidepressants or anti-anxiety drugs) for the past three months, so you may need to maintain your current medication regimen.

What data supports the effectiveness of the Home Alone treatment for cognitive impairment?

Research on similar home-based cognitive interventions shows that they can help improve cognitive function and emotional well-being in elderly individuals living alone. Additionally, programs like the Home Independence Program have shown improvements in functional abilities and confidence in performing everyday activities. ^{1 2 3 4 5}

Is the Home Alone Program for Cognitive Impairment safe for humans?

The available research does not provide specific safety data for the Home Alone Program for Cognitive Impairment, but it highlights general safety concerns for older adults living alone with cognitive impairment, such as risks of injury and medication errors. These studies suggest that interventions like remote monitoring and home modifications can help improve safety for this population. ^{6 7 8 9 10}

How is the Home Alone treatment different from other treatments for cognitive impairment?

The Home Alone treatment is unique because it focuses on providing support and cognitive interventions directly in the home for individuals living alone, which can help reduce feelings of loneliness and isolation that contribute to cognitive decline. This approach is different from traditional treatments that may not address the specific challenges faced by those living alone. ^{3 5 11 12 13}

Research Team

Joseph Gaugler, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for U.S. residents aged 55 or older who live alone, can consent to participate, and have cognitive impairment (CI). They must either have a provider's diagnosis of CI, score between 13-18 on the T-MoCA test, or feel they have memory issues. Excluded are those in assisted living, non-English speakers, participants in similar services, those unwilling or unable to engage actively in the intervention, and individuals with untreated mental health conditions.

Inclusion Criteria

I have been diagnosed with mild cognitive impairment or scored 13-18 on the T-MoCA.

I understand and can agree to medical procedures.

I live by myself in a home or apartment.

Exclusion Criteria

Are currently participating in any other type of service that provides one-to-one psychosocial consultation or independent living coaching

I have changed my mental health medication dosage in the last 3 months.

I am willing and able to participate in the study as required.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Development and Adaptation

Participants engage in the Home Alone intervention to identify treatment components and examine feasibility and relevance.

3 months

7 visits (in-person or virtual)

Phase II: Pilot Testing

Pilot test a revised version of Home Alone to evaluate implementation potential, feasibility, acceptability, and usefulness.

6 months

7 visits (in-person or virtual), final interview for a sub-sample

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

Treatment Details

Interventions

• Home Alone

Trial Overview The 'Home Alone' program is being tested over two phases: Phase I involves a three-month commitment with weekly meetings and surveys; Phase II extends this to six months. The program aims to help cognitively impaired adults who live alone remain active and safe at home by providing coaching sessions.

Participant Groups

Group I: Home Alone Intervention Experimental Treatment 1 Intervention

Home Alone is a semi-structured intervention, tailored to address the individual needs and concerns of the older adult. The participant will engage in about seven psychoeducational coaching sessions, each lasting approximately one hour. The intervention has two key foci: 1. increasing or maintaining home safety and comfort 2. increasing scheduled social engagements and activities. Sessions are also designed to identify formal and informal services and supports to improve to increase assistance and ability to live independently for as long as safely possible. The sessions take place either in-person or remotely (via secure video conferencing or telephone). Ad hoc/ongoing sessions may be provided as needed.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Women with possible or probable Alzheimer's disease who live alone are more likely to be older, poorer, and have milder cognitive impairments compared to those living with others.

Living alone significantly affects the use of medical services, with individuals living alone less likely to seek medical care but more likely to utilize home-based services like homemaker chores and meal deliveries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living alone with Alzheimer's disease: effects on health and social service utilization patterns. Webber, PA., Fox, P., Burnette, D.[2019]

A home-based cognitive stimulation program for patients with Alzheimer's disease helped maintain their cognitive and behavioral functioning while also improving their emotional well-being, unlike the comparison group which showed deterioration.

Caregivers of patients in the cognitive stimulation program also benefited, maintaining their well-being and enhancing their coping resources, highlighting the program's positive impact on both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of family-based strategies on Alzheimer's disease. Quayhagen, MP., Quayhagen, M.[2019]

A home-visiting cognitive intervention (HCI) conducted over 8 weeks significantly improved cognitive function and reduced depression in 258 elderly participants living alone, as measured by the Mini-Mental State Examination and Geriatric Depression Scale.

The intervention was particularly effective for those with cognitive impairment, suggesting that regular cognitive-care services like HCI could help reduce dementia risk and enhance emotional well-being in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Visiting Cognitive Intervention for the Community-Dwelling Elderly Living Alone. Lee, J., Lee, AY.[2020]

In a 3-year study of 1,021 individuals with mild-to-moderate Alzheimer's disease, 35% were found to live alone, predominantly older females with significant cognitive and functional impairments.

For solitary-living patients, lower instrumental activities of daily living (IADL) ability and a higher number of medications were key predictors for using home-help services, indicating that cognitive ability alone does not determine the need for community-based support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solitary living in Alzheimer's disease over 3 years: association between cognitive and functional impairment and community-based services. Wattmo, C., Londos, E., Minthon, L.[2022]

The Home Independence Program (HIP) significantly improved personal outcomes for older adults, such as functional dependency and confidence in daily activities, compared to usual home-care services, based on a study of 200 clients over one year.

Participants in the HIP had a much lower likelihood of needing ongoing services, with odds of requiring additional help being 93% lower at 3 months and 86% lower at 12 months compared to those receiving standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-randomised controlled trial of the Home Independence Program (HIP): an Australian restorative programme for older home-care clients. Lewin, G., Vandermeulen, S.[2022]

Televideo monitoring significantly improved medication compliance in individuals with mild dementia, achieving an 81% compliance rate compared to 66% in the control group, based on over 4000 interactions with 8 participants.

The study demonstrated that while video-monitored participants maintained stable compliance, those without monitoring experienced a decline in compliance, highlighting the potential of this technology to support medication management in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth home monitoring of solitary persons with mild dementia. Smith, GE., Lunde, AM., Hathaway, JC., et al.[2017]

The study identified that most individuals living alone with cognitive impairment (CI) are older, widowed females who do not have a formal diagnosis of Alzheimer's or dementia but still show cognitive difficulties.

These individuals often depend on adult children and paid professionals for care, highlighting the need for targeted support and resources for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living Alone With Cognitive Impairment. Gibson, AK., Richardson, VE.[2017]

Older adults living alone are at increased risk for various adverse outcomes, including falls, medication errors, and self-neglect, especially if they become homebound, which affected 4.5 million Medicare beneficiaries from 2012 to 2018.

Clinicians should assess the home safety of older adults and implement interventions like in-home modifications and remote monitoring to help them live safely, while some may need to consider alternative living arrangements, which can be financially challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric Care in the Community Setting: When Older Adults Can No Longer Live Alone at Home. Kistler, CE.[2022]

In a study of 139 cognitively impaired seniors living alone, 21.6% experienced incidents of harm related to self-neglect or disorientation over an 18-month period, highlighting a significant risk in this population.

Four key risk factors for harm were identified: fewer perceived social resources, lower scores on the Mini-Mental State Examination (MMSE), presence of chronic obstructive pulmonary disease (COPD), and cerebrovascular disorders, which can help primary care providers identify at-risk individuals early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for harm in cognitively impaired seniors who live alone: a prospective study. Tierney, MC., Charles, J., Naglie, G., et al.[2022]

This study is testing the effectiveness of a computer-based cognitive rehabilitation program delivered at home (HomeCoRe) compared to in-person sessions (CoRe) for participants with Mild or Major Neurocognitive Disorders, involving 40 participants over a 6-week period.

The goal is to determine if HomeCoRe is as effective as CoRe, which could support the use of telerehabilitation for ongoing care in cognitive decline, making treatment more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. Bernini, S., Panzarasa, S., Sinforiani, E., et al.[2022]

A new model of home respite and support for individuals with Alzheimer's and their caregivers has been developed, focusing on 24-hour assistance over several consecutive days.

This service is delivered by a single specialized care assistant, which may enhance the quality of care and continuity for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[In-home respite for the families of Alzheimer's patients]. Lucet, F.[2022]

Homebound Learning Opportunities (HLO) offers a unique health promotion and educational outreach service tailored for homebound older adults, providing over 125 individualized learning topics and resources directly in their homes.

Preliminary assessments indicate that participants experience high levels of satisfaction and engagement with the program, suggesting it effectively meets the needs of older adults and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Homebound Learning Opportunities: reaching out to older shut-ins and their caregivers. Penning, M., Wasyliw, D.[2019]

Living alone significantly hampers access to health care and social services for older adults with cognitive impairment, as identified by 76 professionals in a qualitative study across three states.

Professionals noted that older adults living alone face unique challenges, such as lack of advocacy and increased isolation, which contribute to unmet health care needs and safety concerns in a crisis-driven health care system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of the Role of Living Alone in Providing Services to Patients With Cognitive Impairment. Portacolone, E., Nguyen, TT., Bowers, BJ., et al.[2023]

References

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

Living alone with Alzheimer's disease: effects on health and social service utilization patterns. [2019]

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

Differential effects of family-based strategies on Alzheimer's disease. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Home-Visiting Cognitive Intervention for the Community-Dwelling Elderly Living Alone. [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Solitary living in Alzheimer's disease over 3 years: association between cognitive and functional impairment and community-based services. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A non-randomised controlled trial of the Home Independence Program (HIP): an Australian restorative programme for older home-care clients. [2022]

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

Telehealth home monitoring of solitary persons with mild dementia. [2017]

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

Living Alone With Cognitive Impairment. [2017]

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

Geriatric Care in the Community Setting: When Older Adults Can No Longer Live Alone at Home. [2022]

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

Risk factors for harm in cognitively impaired seniors who live alone: a prospective study. [2022]

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

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[In-home respite for the families of Alzheimer's patients]. [2022]

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

Homebound Learning Opportunities: reaching out to older shut-ins and their caregivers. [2019]

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

Perceptions of the Role of Living Alone in Providing Services to Patients With Cognitive Impairment. [2023]