Dementia Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 65 |
Est. completion date | February 15, 2025 |
Est. primary completion date | February 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |