Clinical trial NCT05746390: Home Alone: An Intervention for People With Cognitive Impairment Who Live Alone
Official title: Home Alone: Developing a Home-Based Intervention for People With Cognitive Impairment Who Live Alone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Memory Loss
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 65
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: The primary goal of this proposal is to establish the feasibility, acceptability, and appropriateness of a novel intervention, "Home Alone." Home Alone will be targeted to older persons with CI or Mild Cognitive Impairment (MCI) who live alone in the community. This National Institute on Aging (NIA) Stage I effort will adapt and tailor established, evidence-based mental health and dementia care intervention models (behavioral activation, Skills2Care®, Tailored Activity Program) to reduce environmental stress and enhance engagement in desired activities to improve social well-being and maintain cognition and function for those who live alone with CI. Relying on a robust, mixed methods strategy and an implementation science lens at the outset of intervention development, the investigators seek to position Home Alone as a scalable program that, as its efficacy and effectiveness is determined in subsequent trials, is primed for widespread dissemination and adoption in home-based and community contexts.

The Specific Aims are as follows:

Specific Aim 1 (Phase I): Develop and Adapt Home Alone to Prepare for Pilot Testing. The investigators will identify treatment components and examine feasibility and relevance by obtaining insights from 15 persons with CI who live alone and participate in the Home Alone intervention over a 3-month period. The investigators will utilize the Phase I period to determine whether various elements of Home Alone (e.g., delivery mode, length, and other intervention characteristics) require adaptation. The investigators will use a convergent parallel mixed methods design (i.e., the collection and analysis of quantitative and qualitative data concurrently) when doing so. Through analysis of the various quantitative and qualitative data elements to inform adaptation, the investigators will finalize and refine Home Alone prior to project Phase II (Specific Aim 2).

Specific Aim 2 (Phase II): Pilot Test a Revised Version of Home Alone. This R21 project will evaluate the following indices of implementation potential over a 6-month period: whether Home Alone is carried out as intended and is feasible (the degree to which Home Alone can be successfully delivered); acceptable (Home Alone is agreeable and satisfactory among users), and useful (participants perceive benefit from the Home Alone intervention). A sequential explanatory mixed methods design (a quantitative component followed by a qualitative component) will be utilized to pilot test Home Alone. The investigators will enroll 50 persons living alone with CI over a 6-month period. The investigators will also examine whether key empirical outcomes (perceived loneliness; activity engagement; measures of cognition and functional dependence) change over a 6-month period. Available qualitative data will provide information on how and why Home Alone was beneficial or not for persons with CI and allow for greater understanding of the intervention's mechanisms of benefit.

Home Alone combines Behavioral Activation (BA) with other evidence-based intervention approaches (i.e., Tailored Activity Program (TAP); Skills2Care®) that target the environment in order to tailor activity that is fulfilling and meaningful to persons with CI. An additional intervention component that will be incorporated in Home Alone includes environmental assessments that help the person with CI by removing objects and improving lighting and safety in areas of the home where a desired and meaningful activity will be conducted.

Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* Lives alone in a non-residential setting
* Either 1) provider diagnosis of MCI, 2) Montreal Cognitive Assessment by telephone (T-MoCA) score between 13 and 18, and/or 3) subjective endorsement of memory impairment on screening
* Resides in the US
* Demonstrates capacity to consent

Exclusion Criteria:

Those who do not meet the inclusion criteria above are not eligible. Additionally, researchers would exclude those who:

* Live in assisted living, a group care home, or similar residential setting that provides care and services
* Are not English speaking
* Are currently participating in any other type of service that provides one-to-one psychosocial consultation or independent living coaching
* Have a new or worsening mental health condition and are not receiving ongoing treatment
* Have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics, or anti-psychotics, for the prior three months
* Are not willing/interested in participating or cannot actively participate in the intervention, per researcher discretion

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: Phase I at 1 month
measure: Acceptability of Intervention
timeFrame: Phase I at 3 months
measure: Acceptability of Intervention
timeFrame: Phase II at 3 months
measure: Acceptability of Intervention
timeFrame: Phase II at 6 months
measure: Feasibility of Intervention
timeFrame: Phase I at 1 month
measure: Feasibility of Intervention
timeFrame: Phase I at 3 months
measure: Feasibility of Intervention
timeFrame: Phase II at 3 months
measure: Feasibility of Intervention
timeFrame: Phase II at 6 months
measure: Intervention Appropriateness
timeFrame: Phase I at 1 month
measure: Intervention Appropriateness
timeFrame: Phase I at 3 months
measure: Intervention Appropriateness
timeFrame: Phase II at 3 months
measure: Intervention Appropriateness
timeFrame: Phase II at 6 months
measure: Intervention Treatment Receipt
timeFrame: Phase I at 1 month
measure: Intervention Treatment Receipt
timeFrame: Phase I at 3 months
measure: Intervention Treatment Receipt
timeFrame: Phase II at 3 months
measure: Intervention Treatment Receipt
timeFrame: Phase II at 6 months
Secondary outcomes:
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase I at baseline
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase I at 1 month
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase I at 3 months
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase II at baseline
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase II at 3 months
measure: Social Well-being/Loneliness (Social contact and Support)
timeFrame: Phase II at 6 months
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase I at baseline
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase I at 1 month
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase I at 3 months
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase II at baseline
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase II at 3 months
measure: Social Well-being/Loneliness (Loneliness)
timeFrame: Phase II at 6 months
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase I at baseline
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase I at 1 month
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase I at 3 months
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase II at baseline
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase II at 3 months
measure: Social Well-being/Loneliness (Well-being)
timeFrame: Phase II at 6 months
measure: Activity/Engagement
timeFrame: Phase I at baseline
measure: Activity/Engagement
timeFrame: Phase I at 1 month
measure: Activity/Engagement
timeFrame: Phase I at 3 months
measure: Activity/Engagement
timeFrame: Phase II at baseline
measure: Activity/Engagement
timeFrame: Phase II at 3 months
measure: Activity/Engagement
timeFrame: Phase II at 6 months
measure: Cognition
timeFrame: Phase I at screening
measure: Cognition
timeFrame: Phase I at 1 month
measure: Cognition
timeFrame: Phase I at 3 months
measure: Cognition
timeFrame: Phase II at screening
measure: Cognition
timeFrame: Phase II at 3 months
measure: Cognition
timeFrame: Phase II at 6 months
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
timeFrame: Phase I at baseline
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
timeFrame: Phase I at 1 month
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
timeFrame: Phase I at 3 months
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
timeFrame: Phase II at baseline
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living
timeFrame: Phase II at 3 months
measure: Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)
timeFrame: Phase II at 6 months
measure: Functional Dependence (Physical functioning)
timeFrame: Phase I at baseline.
measure: Functional Dependence (Physical functioning)
timeFrame: Phase I at 1 month
measure: Functional Dependence (Physical functioning)
timeFrame: Phase I at 3 months
measure: Functional Dependence (Physical functioning)
timeFrame: Phase II at baseline
measure: Functional Dependence (Physical functioning)
timeFrame: Phase II at 3 months
measure: Functional Dependence (Physical functioning)
timeFrame: Phase II at 6 months
measure: Behavioral Activation Scale
timeFrame: Phase I at baseline.
measure: Behavioral Activation Scale
timeFrame: Phase I at 1 month.
measure: Behavioral Activation Scale
timeFrame: Phase I at 3 months.
measure: Behavioral Activation Scale
timeFrame: Phase II at baseline.
measure: Behavioral Activation Scale
timeFrame: Phase II at 3 months.
measure: Behavioral Activation Scale
timeFrame: Phase II at 6 months.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase I at baseline.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase I at one month.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase I at three months.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase II at baseline.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase II at 3 months.
measure: Utilization of Unpaid Social Support Care Resources
timeFrame: Phase II at 6 months.
measure: Paid Service Use
timeFrame: Phase I at baseline.
measure: Paid Service Use
timeFrame: Phase I at one month.
measure: Paid Service Use
timeFrame: Phase I at three months.
measure: Paid Service Use
timeFrame: Phase II at baseline.
measure: Paid Service Use
timeFrame: Phase II at 3 months.
measure: Paid Service Use
timeFrame: Phase II at 6 months.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joseph Gaugler, PhD
role: PRINCIPAL_INVESTIGATOR
References: