Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use

Anxiety Clinical Trial

— TLC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689179
• Other study ID #: 1R01AG061946-01 (Utz)
• Secondary ID: R01AG061946
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: May 1, 2024
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Burden, Dependency
• Caregiver
• Dementia

Intervention

Behavioral:
• Time for Living and Caring (TLC)
"Time for Living & Caring" (TLC) is an online, self-administered intervention. It includes three types of modules: 1) "virtual coaching" module (defined as a series of prompts, reminders, and suggestions that guide caregivers through assessment, goal setting, and goal review activities) to monitor respite time-use and time-use goals, 2) an interactive calendar that can be used to schedule and track respite time, 3) resource pages (including links, printable forms, video guides) that provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"	Self-report multi-item index (8-items, additive), with higher scores indicating greater presence and frequency of depressive symptoms; scores are standardized to a distribution of depression-related symptoms on a population-distribution with a mean of 50 and standard deviation of 10 (T-score). Participants self-reported to the following survey questions: "During the past 7 days, I felt worthless, helpless, depressed, hopeless, like a failure, unhappy, that I had nothing to look forward to, that nothing could cheer me up," each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of depressive symptoms.	Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Primary	Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form	Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.	Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Primary	Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"	Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.	Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Secondary	Respite Time-Use (in Hours Per Week)	Participants were asked to self-report number of hours they typically receive respite in a typical week. The following survey question and description were asked to all participants "On average, how many hours of respite do you get in a typical week? These would be hours that you can completely turn-off your caregiving responsibilities, while the needs and safety of your family member are not your primary responsibility."	Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
Secondary	Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"	Self-report single item measure, assessing partcipants' perceived level of satisfaction with their respite time and time use. Respondents were asked about their level of agreement with the following statement: "I am happy with what I choose to do during my respite time". Responses were recorded on a five-point Likert scale with strongly disagree=1 and strongly agree 5. This variable is dichotomized, showing the count (and percentage) of the sample that responded with "agree" or "stongly agree." This self-report assessment was only collected at baseline (pre-intervention) and at time 16 (post-intervention)	Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B