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

Home Alone: Developing a Home-Based Intervention for People With Cognitive Impairment Who Live Alone

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

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Dementia; Memory Loss
• Intervention / Treatment: Behavioral: Home Alone

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.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Gaugler, PhD; Phone Number: 612-626-2485; Email: gaug0015@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Joseph Gaugler, PhD; Phone Number: 612-626-2485; Email: gaug0015@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home Alone 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: increasing or maintaining home safety and comfort; 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; See Home Alone description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase I at baseline
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase I at 1 month
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase I at 3 months
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase II at baseline
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase II at 3 months
Social Well-being/Loneliness (Social contact and Support)	Lubben Social Network Scale-6 6 item scale evaluating social engagement; Items assess social contact and support including family and friends; Scores range from 0 to 30, with higher scores representing more social engagement.	Phase II at 6 months
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase I at baseline
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase I at 1 month
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase I at 3 months
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase II at baseline
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase II at 3 months
Social Well-being/Loneliness (Loneliness)	De Jong Gierveld Loneliness Scale (Short - 6 items) will measure emotional and social loneliness; Scores range from 1-6. Higher scores indicate greater levels of loneliness.	Phase II at 6 months
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase I at baseline
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase I at 1 month
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase I at 3 months
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase II at baseline
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase II at 3 months
Social Well-being/Loneliness (Well-being)	Geriatric Depression Scale-Short Form -15 items measuring emotional well-being; scores range from 0-15; Scores under 5 indicate that depression is unlikely, scores of 5 or more suggest depression.	Phase II at 6 months
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase I at baseline
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase I at 1 month
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase I at 3 months
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase II at baseline
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase II at 3 months
Activity/Engagement	Pleasant Events Schedule: Alzheimer's Disease (AD) short form - 20 activity items measured on a scale divided into two parts. The first part of the scale measures frequency of participation and availability of the event (ltems are rated from 0 to 2; total scores can range from 0 to 40). The second part of the scale assesses current and/or past enjoyment of those activities (ltems are rated from 0 to 1; total scores can range from 0 to 20). Higher scores indicate higher levels of activity on both subscales.	Phase II at 6 months
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.	Phase I at screening
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.	Phase I at 3 months
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.	Phase II at screening
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.	Phase II at 3 months
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest mild cognitive dysfunction.	Phase II at 6 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase I at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase I at 1 month
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase I at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase II at baseline
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase II at 3 months
Functional Dependence - Activities of Daily Living (ADL)/Independent Activities of Daily Living (IADL)	Fifteen item scale created from Katz Activities of Daily Living- 6 item scale measuring ability to perform activities of daily living, 8 items from the Lawton Independent Activities of Daily Living scale assessing 8 domains of independent living skills (including shopping and taking medications) and 1 item on hygiene from the Routine Task Inventory; Scores range from 0-30 with higher scores needing more help with ADL/IADLs.	Phase II at 6 months
Cognition	Telephone Montreal Cognitive Assessment (T-MoCA) - measure assessing 8 areas of cognition used over the phone to screen for Mild Cognitive Impairment; scores range from 0-22; with higher scores indicating better cognitive functioning. Scores 18 or below suggest cognitive dysfunction.	Phase I at 1 month
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase I at baseline.
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase I at 1 month
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase I at 3 months
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase II at baseline
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase II at 3 months
Functional Dependence (Physical functioning)	US Health Interview Survey - assesses engagement in physical activities in the prior two weeks. A composite index of physical activity is computed by summing the products of the number of minutes in each activity (9 are listed and there is an open response "other" option) and how many times in the past two weeks the engaged in the activity for the 9 activities and any open response activities, the total number of minutes during the past 2 weeks is divided by 60 minutes, and then by 2, to determine the number of hours of physical activity per week. The minimum composite index is 0. A higher composite index indicates more physical activity.	Phase II at 6 months
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase I at baseline.
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase I at 1 month.
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase I at 3 months.
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase II at baseline.
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase II at 3 months.
Behavioral Activation Scale	8 items based on Kanter et al., 2007 behavioral activation for depression scale. 1 item developed and added per researcher discretion. Responses range from 0 (meaning not at all) to 6 (meaning completely). Two items are reverse coded. Scores at each time point will be averaged.	Phase II at 6 months.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase I at baseline.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase I at one month.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase I at three months.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase II at baseline.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase II at 3 months.
Utilization of Unpaid Social Support Care Resources	10-item yes or no checklist developed based on Kasper et al., 2015. 1 additional open-ended item is added to ask about other forms of unpaid social support. The total number of yes responses for each participant will be summed at each time point.	Phase II at 6 months.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase I at baseline.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase I at one month.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase I at three months.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase II at baseline.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase II at 3 months.
Paid Service Use	12-item measure assessing the utilization of paid community-based, residential, or other services. Response options include "I use this service," "I would like to use this service," and "I don't need to use this service." The number of services used will be summed at each time point for each participant.	Phase II at 6 months.

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Joseph Gaugler, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 15, 2025

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Memory Disorders
• Other Study ID Numbers: STUDY00017313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data and appropriate study materials/documentation will be deposited and made available through the National Archive of Computerized Data on Aging (NACDA), a NIA/NIH funded repository.
• IPD Sharing Access Criteria: Data and supporting documents/materials will be deposited in the NACDA repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No