Clinical trial NCT03689179: Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use
Official title: Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Burden, Dependency
Caregiver
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-09-28
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
timeFrame: 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
measure: Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
timeFrame: 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 outcomes:
measure: Respite Time-Use (in Hours Per Week)
timeFrame: Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
measure: Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"
timeFrame: Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B
Other outcomes:
measure: Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"
timeFrame: 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
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: rebecca utz, PhD
role: PRINCIPAL_INVESTIGATOR
References: