Home Alone Program for Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must not be taking: Psychotropics
Disqualifiers: Assisted living, Non-English, Mental health, others
No Placebo Group
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.
12345Is 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.
678910How 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.
35111213Eligibility 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.
+2 more
Exclusion Criteria
I do not speak English.
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.
+3 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Home Alone InterventionExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Living alone with Alzheimer's disease: effects on health and social service utilization patterns. [2019]Subjects with possible or probable Alzheimer's disease who live alone are more likely to be women, and more likely to be poor than those living with others. They are also older and have milder cognitive impairments and a shorter disease duration. Living arrangement is a significant predictor of service utilization even with other factors held constant. Subjects living alone were less likely to use medical services such as physicians and hospitals, and more likely to use services such as homemaker chore and home-delivered meals. In addition, they were more likely to use no services than those living with others.
Differential effects of family-based strategies on Alzheimer's disease. [2019]Assessed was the efficacy of a home-based program of cognitive stimulation for the functional status of patients with Alzheimer's disease, as well as the well-being of caregivers. Ten family dyads (caregiver and patient) participated in the intervention and six family dyads formed the comparison group. Patients in the program maintained their levels of cognitive and behavioral functioning while improving emotionally, whereas the comparison group patients deteriorated. Similarly, the caregivers in the program maintained well-being and enhanced their coping resources.
Home-Visiting Cognitive Intervention for the Community-Dwelling Elderly Living Alone. [2020]The elderly living alone feel lonelier and more isolated than do those live with others, and they are at higher risk for cognitive decline and depression. This study aimed to assess whether a home-visiting cognitive intervention (HCI) can have positive effects on cognitive improvement for the elderly who living alone.
Solitary living in Alzheimer's disease over 3 years: association between cognitive and functional impairment and community-based services. [2022]Many individuals with Alzheimer's disease (AD) live alone, and this figure is expected to increase. This study aimed to describe the cognitive and functional abilities of solitary-living AD patients, and the potential predictors of their usage of community-based services.
A non-randomised controlled trial of the Home Independence Program (HIP): an Australian restorative programme for older home-care clients. [2022]The Home Independence Program (HIP) is a short-term restorative programme targeted at older home-care clients, who do not have a diagnosis of dementia, when they are first referred for assistance or when they are referred for additional services because their needs have increased. This study compared the outcomes for individuals who participated in HIP with those of individuals who received 'usual' home-care services. The study was conducted in metropolitan Perth, Western Australia, between 2001 and 2003, when HIP was being trialled as a service in just one region. One hundred clients were recruited into each group and were visited at home on three occasions--service start and at 3 months and 1 year. Standardised outcome measures were used to measure functional dependency, morale, confidence in performing everyday activities without falling and functional mobility. Service outcomes were also examined at 3 months and 1 year. The HIP group showed improvements on all personal outcome measures compared with the control group. These improvements were, except for the morale scale, significantly associated with group assignment even when baseline differences between the groups were adjusted for. As regards service outcomes, the odds of the individuals who received HIP still requiring services was 0.07 (95% CI = 0.03-0.15, P
Telehealth home monitoring of solitary persons with mild dementia. [2017]Medication safety is a special concern for the 30% to 40% of dementia patients who live alone at the time of diagnosis, and it plays an important part in relocation decisions. Televideo monitoring could improve medication self-administration accuracy and improve mood for persons with mild dementia who live alone or spend a significant amount of their day alone. The authors used 2-way interactive video technology to monitor medication compliance of 8 persons with mild dementia. They conducted more than 4000 contacts with these persons and found adequate technical outcome in 82% of calls. End medication compliance was 81% in the video-monitored group compared to 66% in the controls (P
Living Alone With Cognitive Impairment. [2017]Although most individuals experiencing cognitive impairment (CI) reside with a caregiver, an estimated 800,000 live alone. Such individuals may have an increased risk for injury to self or others through self-neglect as a result of the CI symptoms. While persons living alone with CI have been identified as an important area for needed research, few studies have been able to examine this population due to the challenges of identifying and recruiting study participants. By using the National Health & Aging Trends Study data set, the researchers explored the characteristics to describe this population. The results of this study indicated that the majority of persons living with CI were older, widowed females who were not diagnosed with Alzheimer's or dementia but tested positive on cognitive screening measures. Further, the majority of persons living alone with CI relied on adult children and paid professionals as the primary care providers.
Geriatric Care in the Community Setting: When Older Adults Can No Longer Live Alone at Home. [2022]Older adults living alone at home are at risk of many adverse outcomes, including injuries from falls, firearms, and driving; adverse drug events due to drug errors; and self-neglect or elder abuse. An estimated 4.5 million Medicare beneficiaries became homebound between 2012 and 2018. Becoming homebound increases the risk of harm for older adults. Clinicians should evaluate the home safety of older adult patients, which requires assessing their medical conditions, home physical environment, and social circumstances. Identified problems should be addressed with interventions that allow patients to live safely in the least restrictive environment possible. The least restrictive interventions are in-home modifications (eg, installation of handrails and grab bars) and use of remote monitoring, in-home services, and shopping and transportation services. Daytime participation in senior centers or adult day care also can be useful. Some patients will require a change in living situation, with a move to senior housing or retirement communities, group homes, assisted living communities, skilled nursing facilities, or the home of a family member. Some of these alternative living situations require financial resources that a patient or family members may not have. Public assistance is available in some cases, if patients meet eligibility requirements.
Risk factors for harm in cognitively impaired seniors who live alone: a prospective study. [2022]To identify risk factors for harm due to self-neglect or behaviors related to disorientation in cognitively impaired seniors who live alone that can be used in primary care.
HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. [2022]Background: Given the limited effectiveness of pharmacological treatments for cognitive decline, non-pharmacological interventions have gained increasing attention. Evidence exists on the effectiveness of cognitive rehabilitation in preventing elderly subjects at risk of cognitive decline and in reducing the progression of functional disability in cognitively impaired individuals. In recent years, telerehabilitation has enabled a broader application of cognitive rehabilitation programs. The purpose of this study is to test a computer-based intervention administered according to two different modalities (at the hospital and at home) using the tools CoRe and HomeCoRe, respectively, in participants with Mild or Major Neurocognitive Disorders. Methods: Non-inferiority, single-blind randomized controlled trial where 40 participants with Mild or Major Neurocognitive Disorders will be assigned to the intervention group who will receive cognitive telerehabilitation through HomeCoRe or to the control group who will receive in-person cognitive intervention through CoRe, with the therapist administering the same computer-based exercises. The rehabilitative program will last 6 weeks, with 3 sessions/week, each lasting ~45 min. All the participants will be evaluated on an exhaustive neuropsychological battery before (T0) and after (T1) the intervention; follow-up visits will be scheduled after 6 (T2) and 12 months (T3). Discussion: The results of this study will inform about the comparability (non-inferiority trial) of HomeCoRe with CoRe. Their equivalence would support the use of HomeCoRe for at distance treatment, favoring the continuity of care. Ethics and Dissemination: This study has been approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT04889560). The dissemination plan includes the scientific community through publication in open-access peer-reviewed scientific journals and presentations at national and international conferences. Trial Registration: Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT04889560 (registration date: May 17, 2021).
[In-home respite for the families of Alzheimer's patients]. [2022]An innovative and unique model of respite and support at home for people with Alzheimer's and their carers has been created. The quality of the service provided is based on the principle of home assistance, 24 hours a day and for several consecutive days, provided by a single specialised care assistant.
Homebound Learning Opportunities: reaching out to older shut-ins and their caregivers. [2019]Homebound Learning Opportunities (HLO) represents an innovative health promotion and educational outreach service for homebound older adults and their caregivers. It provides over 125 topics for individualized learning programs delivered to participants in their own places of residence, an audiovisual lending library, educational television programming, and a peer counseling service. Shut-ins are recruited as instructors and as participants in service projects that benefit the greater community. Preliminary assessments reveal high levels of participation and satisfaction with the program.
Perceptions of the Role of Living Alone in Providing Services to Patients With Cognitive Impairment. [2023]The potential role of living alone in either facilitating or hampering access to and use of services for older adults with cognitive impairment is largely unknown. Specifically, it is critical to understand directly from health care and social services professionals how living alone creates barriers to the access and use of supportive health care and social services for racially and ethnically diverse patients with cognitive impairment.