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Home Alone Program for Cognitive Impairment

N/A

Recruiting

Led By Joseph Gaugler, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrates capacity to consent

Lives alone in a non-residential setting

Must not have

Are not English speaking

Have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics, or anti-psychotics, for the prior three months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase ii at 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate a program to help older adults with cognitive impairment who live alone to stay safe and engaged. Participants will complete 3 surveys, 7 weekly meetings with a coach, and a final interview.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since 'Home Alone' is not a medication but an engagement and safety program for people with cognitive impairments living alone, it does not have side effects like drugs do. However, participation requires time commitment for meetings and surveys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and can agree to medical procedures.

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I live by myself in a home or apartment.

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I am 55 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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

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My mental health condition is new or getting worse, and I am not currently receiving treatment for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase ii at 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase ii at 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase ii at 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention

Feasibility of Intervention

Intervention Appropriateness

+1 more

Secondary study objectives

Activity/Engagement

Behavioral Activation Scale

Cognition

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met