Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use

Study Overview
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Brief Summary
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The Time for Living & Caring (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (n=150) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.

Detailed Description
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The purpose of this study is to redevelop the Time for Living and Caring (TLC) intervention, in which dementia caregivers are taught strategies to assess and identify ways to spend upcoming periods of respite time, to a fully online, self-administered virtual coaching format, and then to pilot-test the new TLC intervention for feasibility and efficacy. Aim 1 is to modify, adapt, and refine the existing intervention modules, utilizing a community-engaged design process where stakeholders (i.e., current or former caregivers, diverse community leaders, and respite providers) will work as consultants alongside the research, technical, and creative teams to develop and provide feedback on the TLC prototypes. The primary endpoint of this phase of the study is a fully-developed, tested, and ready-to-launch web-based intervention. Aim 2 is to conduct a pilot test with dementia caregivers who are currently using respite, using a full powered pilot sample and a randomized waitlist-control experimental design where participants are exposed to the redeveloped TLC intervention for 8 weeks and will provide assessments of daily respite use, respite time-use satisfaction, and wellbeing. These pilot data will be used to assess feasibility and to explore hypotheses regarding the potential efficacy of the intervention as well as the mechanism - time-use satisfaction -underlying the intervention's effect on wellbeing. **Aim 2 uses a clinical trial methodology, and is therefore the part of the study that is described in detail here ** Aim 3 is intended to explore future implementation with respite providers, as yet another assessment of the intervention's feasibility. We will host webinars to demonstrate the features and functionality of the TLC intervention. We will then ask providers for feedback on their likelihood of implementation and barriers to using TLC with their clients. Together, these three aims represent a comprehensive approach to Stage 1 behavioral intervention research activities, with the overall goal of (re)developing an intervention that is useful to dementia caregivers and is scalable to real world applications. Each aim has a separate sample and study design. Aim 1 Sample & Design: a dozen community stakeholders, consisting of current and former AD/ADRD caregivers, respite providers, and community leaders that represent diverse local populations. These participants will be considered consultants (not human subjects), per IRB. They are providing feedback and advice to the research team and technical designers in the creation and translation of the TLC intervention tools to a self-administered, app-delivered intervention. Aim 2 Sample & Design: a total of 150 respite-using AD/ADRD caregivers. This is the sample that is participating in the clinical trial. ** eligibility, measures, study design for this phase of the overall project are described in greater detail here ** Aim 3 Sample & Design: a minimum of 100 respite providers, located anywhere in the US, such as staff from home health agencies, adult day care centers, area agencies on aging, long term care communities, hospices, hospitals, etc. Eligibility is based on their interest and willingness to learn more about the TLC intervention. This sample will provide feedback on the features and functionality of the TLC intervention, as well as specific advice on how it could serve their clients and be disseminated in the future. This is human subjects research, but is not part of the clinical trial.

Official Title
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Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy

Conditions
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Anxiety, Burden, Dependency, Caregiver

Intervention / Treatment
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* Behavioral: Time for Living and Caring (TLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: caregivers to persons with Alzheimer's Disease or Related Dementia (AD/ADRD) (self-identified) use formal or informal respite for at least 4 hours per week. primary caregiver (self-identified) co-residing with the care recipient 18 years or older AND able to read and write in English. Exclusion Criteria: caregivers to persons with disability or chronic condition, and not Alzheimer's Disease and Related Dementia (AD/ADRD) caregivers who do not use respite for at least 4 hours per week noncoresidential caregivers younger than 18 years not able to read and write in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study uses a full-powered pilot sample (n=150) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention. After an initial orientation/control period (4 weeks), group A will receive access to the TLC intervention for 8 weeks, followed by an optional 8-week control period where they can continue to use the TLC intervention if they choose. After the initial 4-week orientation period, Group B will receive 8 weeks of waitlist (no treatment) control, followed by access to the TLC intervention for 8 weeks. Primary outcomes (defined as anxiety, caregiver burden) will be assessed by electronically delivered surveys every 4 weeks; respite time-use and time-use satisfaction will be assessed using ecological momentary analysis for each respite period taken during the 20-week study period; feasibility will be assessed using fixed-choice and open-ended survey questions collected post-intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Follow-up (Group A)<br>After an initial orientation/control period (4 weeks), group A will receive access to the Time for Living & Caring (TLC) intervention for 8 weeks, followed by an optional 8-week control period where they can continue to use the TLC intervention if they choose. | Behavioral: Time for Living and Caring (TLC)<br>* Time for Living & Caring (TLC) is an online, self-administered intervention. It includes three types of modules: a virtual coaching module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?. Optional modules include interactive online forum, peer-to-peer chat functions, and videos or messages to provide daily affirmation, inspiration, and humor for caregivers.<br>|
| Experimental: Wait-List Control w/Treatment (Group B)<br>After the initial 4-week orientation period, Group B will receive 8 weeks of waitlist (no treatment) control, followed by access to the Time for Living & Caring (TLC) intervention for 8 weeks. | Behavioral: Time for Living and Caring (TLC)<br>* Time for Living & Caring (TLC) is an online, self-administered intervention. It includes three types of modules: a virtual coaching module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?. Optional modules include interactive online forum, peer-to-peer chat functions, and videos or messages to provide daily affirmation, inspiration, and humor for caregivers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Anxiety symptoms, as measured by Anxiety Scale of Hospital Anxiety & Depression Scale | Self-report multi-item index (7 items; range 0-21, with higher score indicating higher anxiety) | Baseline (week 1, pre-intervention) & Post-intervention (week-12 for Group A and week-20 for Group B) | 
| Decrease in caregiver burden score, as measured by Caregiver Burden Inventory | Self-report multi-item index (24 items; range 0-96, with lower scores indicating lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks). | Baseline (week 1, pre-intervention) & Post-intervention (week-12 for Group A and week-20 for Group B) | 
| Feasibility: How comprehensive are the Time for Living & Caring (TLC) intervention materials, as measured with post-intervention surveys with participants | Open-ended questions regarding the comprehensibility of TLC intervention materials via e-survey | Post-intervention (week-12 for Group A and week-20 for Group B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respite Time-Use Satisfaction (experienced) | Self-report single-item measure to describe ones' experience with respite time-use. Collected via ecological momentary assessment (EMA), following each distinct respite period. If you had respite today, how satisfied were you with your respite time? (1, not at all satisfied to 5, very satisfied) . Higher scores indicate higher levels of time-use satisfaction. | Daily, up to 140 days, from date of randomization until the date of final data collection at week-20. Only reported for days in which respondent had respite. | 
| Respite Time-Use Satisfaction (evaluative) | Self-report single-item measure to describe ones' evaluation of their respite time-use. Collected via ecological momentary assessment (EMA), following each distinct respite period. If you had respite today, did your respite time make you feel positive/ negative about being caregiver? (1, not at all positive to 5, very positive). Higher numbers indicate higher levels of time-use satisfaction. | Daily, up to 140 days, from date of randomization until the date of final data collection at week-20. Only reported for days in which respondent had respite |