AnxietyTLCNCT03689179
Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use
A study testing Time for Living and Caring (TLC) in people with Anxiety and Burden, Dependency, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Burden, Dependency, Caregiver
- What is being tested?
- Time for Living and Caring (TLC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy
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.
Read the 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.
- Conditions
- Anxiety, Burden, Dependency, Caregiver
- Being tested
- Time for Living and Caring (TLC)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time for Living and Caring (TLC)Behavioural
"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?.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Follow-up (Group A) | Experimental | Group A received access to the full "Time for Living \& Caring" (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants. Receives: Behavioral: Time for Living and Caring (TLC) |
| Wait-List Control w/Treatment (Group B) | Experimental | Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full "Time for Living \& Caring" (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants. Receives: Behavioral: Time for Living and Caring (TLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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 (2)
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."
Measured: Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
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)
Measured: Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start20 Oct 2020
- Primary completion5 Aug 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rebecca Utz, University of Utah
- Investigators
- rebecca utz, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689179
- Sponsor's protocol ID
- 1R01AG061946-01 (Utz)
- Other IDs
- R01AG061946
- Acronym
- TLC
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2018
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary data analyses by investigators outside of the original TLC study team. The PI agrees to make available data within one year of the completion of the funded project period. De-identified individual data will be available directly from the PI. The PI agrees to share data and resources in a manner that is fully consistent with NIH data and resource sharing policies and applicable laws and regulations.
Publications
Iacob E, Caserta M, Donaldson G, Sparks C, Terrill A, Thompson A, Wong B, Utz RL. Evaluating the Efficacy of Time for Living and Caring: An Online Intervention to Support Dementia Caregivers' Use of Respite. Innov Aging. 2024 Apr 26;8(5):igae043. doi: 10.1093/geroni/igae043. eCollection 2024.
PubMed 38803611
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Coaching to Maximize Dementia Caregivers' Respite Time-Use: A Stage 1 Pilot Test for Feasibility and Efficacy
- ClinicalTrials.gov ID
- NCT03689179
- Acronym / sponsor ID
- TLC / 1R01AG061946-01 (Utz)
- Conditions
- Anxiety, Burden, Dependency, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Follow-up (Group A) | Experimental | Behavioral: Time for Living and Caring (TLC)Group A received access to the full "Time for Living \& Caring" (TLC) intervention for 8 weeks (calendar + coaching + resources), followed by an 8-week maintenance period where they could continue to use the TLC intervention. The TLC intervention turned off after 16 weeks of exposure for all participants. |
| Wait-List Control w/Treatment (Group B) | Experimental | Behavioral: Time for Living and Caring (TLC)Group B received 8 weeks of waitlist control (minimal treatment - calendar only) , followed by access to the full "Time for Living \& Caring" (TLC) intervention for an additional 8 weeks (calendar + coaching + resources). The TLC intervention turned off after 16 weeks of exposure for all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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?. | Behavioural | Treatment with Follow-up (Group A), Wait-List Control w/Treatment (Group B) |
Primary outcome
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form
Time frame: 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
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.
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"
Time frame: 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
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.
2 secondary outcomes
Respite Time-Use (in Hours Per Week)
Time frame: Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"
Time frame: Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38803611Iacob E, Caserta M, Donaldson G, Sparks C, Terrill A, Thompson A, Wong B, Utz RL. Evaluating the Efficacy of Time for Living and Caring: An Online Intervention to Support Dementia Caregivers' Use of Respite. Innov Aging. 2024 Apr 26;8(5):igae043. doi: 10.1093/geroni/igae043. eCollection 2024.
- Individual participant dataSharing planned: Yes. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary data analyses by investigators outside of the original TLC study team. The PI agrees to make available data within one year of the completion of the funded project period. De-identified individual data will be available directly from the PI. The PI agrees to share data and resources in a manner that is fully consistent with NIH data and resource sharing policies and applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rebecca utz, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time for Living and Caring (TLC) in people with Anxiety and Burden, Dependency, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Symptoms, as Measured by PROMIS Anxiety Short Form (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.