Home Alone: An Intervention for People With Cognitive Impairment Who Live Alone

NCT05746390 | Completed

• 1 other identifier: STUDY00017313
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Cognitive Impairment; Dementia; Memory Loss

Outcome Measures

Primary Outcomes (16)

• Acceptability of Intervention

  Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.

  Phase I at 1 month

• Acceptability of Intervention

  Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.

  Phase I at 3 months

• Acceptability of Intervention

  Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.

  Phase II at 3 months

• Acceptability of Intervention

  Acceptability of Intervention Measure - 4 item scale evaluating program acceptability. The measure evaluates the likeability of the intervention (e.g. I like the intervention; I welcome the intervention; the intervention meets my approval; the intervention is appealing to me). Items are rated on a scale of agreement (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20, with higher scores indicating higher levels of acceptability.

  Phase II at 6 months

• Feasibility of Intervention

  Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.

  Phase I at 1 month

• Feasibility of Intervention

  Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.

  Phase I at 3 months

• Feasibility of Intervention

  Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.

  Phase II at 3 months

• Feasibility of Intervention

  Feasibility of Intervention Measure - 4 item scale evaluating program feasibility; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems implementable; the intervention seems doable; the intervention seems possible; the intervention seems easy to use). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater feasibility.

  Phase II at 6 months

• Intervention Appropriateness

  Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.

  Phase I at 1 month

• Intervention Appropriateness

  Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.

  Phase I at 3 months

• Intervention Appropriateness

  Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.

  Phase II at 3 months

• Intervention Appropriateness

  Intervention Appropriateness Measure - 4 item scale evaluating program appropriateness; The measure includes four statements about the feasibility of intervention implementation (ex. the intervention seems fitting; the intervention seems suitable; the intervention seems applicable; the intervention seems liked a good match). Items are rated on a five-point scale (completely disagree, disagree, neither agree or disagree, agree, completely agree). Scores range from 4-20. Higher scores indicate greater appropriateness.

  Phase II at 6 months

• Intervention Treatment Receipt

  Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.

  Phase I at 1 month

• Intervention Treatment Receipt

  Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.

  Phase I at 3 months

• Intervention Treatment Receipt

  Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.

  Phase II at 3 months

• Intervention Treatment Receipt

  Intervention Treatment Receipt Checklist Measure - Eleven item checklist designed for study, measuring whether the coach delivered key aspects of the intervention. The measure includes 10 Likert scale items and one open-ended question on the appropriateness and acceptability of Home Alone and the extent to which Home Alone helps participants with CI modify their environment, engage in pleasant activities, and access social and other resources. The 10 items are scored on a 5 point Likert scale with a total score ranging from 0-50, where higher scores indicate greater treatment fidelity and acceptability of the intervention.

  Phase II at 6 months

Secondary Outcomes (60)

• Social Well-being/Loneliness (Social contact and Support)

  Phase I at baseline

• Social Well-being/Loneliness (Social contact and Support)

  Phase I at 1 month

• Social Well-being/Loneliness (Social contact and Support)

  Phase I at 3 months

• Social Well-being/Loneliness (Social contact and Support)

  Phase II at baseline

• Social Well-being/Loneliness (Social contact and Support)

  Phase II at 3 months

Study Arms (1)

Home Alone Intervention

EXPERIMENTAL

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.

Behavioral: Home Alone

Interventions

Home Alone BEHAVIORAL

See Home Alone description.

Home Alone Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Memory Disorders

Interventions

Home Environment

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Residence Characteristics; Demography; Population Characteristics; Family Characteristics; Socioeconomic Factors; Environment; Environment and Public Health; Epidemiologic Measurements; Public Health

Study Officials

• Joseph Gaugler, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 27, 2023
• Study Start: April 15, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Data and supporting documents/materials will be deposited in the NACDA repository.

Locations

US (1)