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Family CaregiversNCT04986904

Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers

A study testing SHUTi (Sleep Healthy Using the Internet) in people with Family Caregivers and Insomnia, run by University of Virginia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHUTi (Sleep Healthy Using the Internet)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited States
Study dates
11 Jan 2022to 19 Mar 2023
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-report providing high-intensity unpaid care (e.g., practical, medical, and/or emotional support) to a family member or "family-like" close individual, operationalized as a function of time spent caregiving and care task involvement.
  • Self-report expecting to continue provide high-intensity care for at least another 3 months.
  • Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study.
  • Insomnia severity index score >= 10
  • Residing in the United States or U.S. territory
  • English literacy

Who cannot join

  • Unusual average bed/wake times, including for shift work
  • Current behavioral/psych treatment for insomnia
  • Medical contraindication (Restless Leg Syndrome/Periodic Limb Movement Disorder, Obstructive Sleep Apnea, narcolepsy, parasomnia, dementia, Parkinson's, Huntington's, stroke, traumatic brain injury, brain infection/tumor, pregnancy/breastfeeding, hyperthyroidism, cancer, severe respiratory disease, epilepsy)
  • Psychiatric contraindications (mania/hypomania, alcohol or substance abuse/dependence)
  • Changes to prescription medications in the past 3 months (sleep, steroid, amphetamine, other wake-promoting)
  • Severe computer literacy challenges

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach

The overall objective of this mixed-methods proposal is to answer the focused research question: What tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of Sleep Healthy Using the Internet (SHUTi) for caregivers? The SHUTi program is a fully-automated Internet-delivered cognitive-behavioral therapy for insomnia (CBT-I) program. We will identify caregiving-related user- and environment characteristics that affect the use and impact of SHUTi, and other Internet interventions more broadly, for caregivers. We will recruit 100 high-intensity caregivers with insomnia to complete a baseline assessment of insomnia and caregiving context. Caregivers will then receive access to SHUTi in an open-label trial. At the end of the 9-week intervention period, caregivers will complete post-assessment and be categorized according to their level of engagement with the 6 SHUTi intervention lessons (or weekly "Cores"). We will test whether caregivers' engagement with SHUTi (i.e., being a non-user vs. incomplete user vs. complete user) is associated with their caregiving-related user characteristics (i.e., caregiving strain, self-efficacy, and guilt) and environment characteristics (i.e., proximity to care recipient; care recipient functional, cognitive, and behavioral status; caregiving tasks). Caregivers' barriers to and motivations for SHUTi engagement will be described from open-ended survey responses specific to participants' level of engagement as part of post-assessment. We will identify non-users' barriers to SHUTi adoption, the extent to which barriers were related to caregiving, and what modifications may have increased their motivation to try SHUTi. We will also identify users' (incomplete and complete) SHUTi usage barriers and motivations, the extent to which these were related to caregiving, and how tailoring may improve usage by increasing salience to caregivers. Thematic coding will also examine how caregivers' recommendations generalize to other evidence-based digital health interventions. Among caregivers using SHUTi, we will test whether the effects of SHUTi on cognitive mechanisms of change targeted by SHUTi (i.e., more adaptive sleep beliefs, internalized sleep locus of control) are associated with differences in caregiving-related user or environment characteristics.

Being tested
SHUTi (Sleep Healthy Using the Internet)
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHUTi (Sleep Healthy Using the Internet)Behavioural

    Also called Cognitive-behavioral therapy for insomnia, CBT-I

    Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

Study groups in NCT04986904
Study groupRoleWhat they receive
SHUTi (Sleep Healthy Using the Internet)ExperimentalParticipants will be assigned to the SHUTi (Sleep Healthy Using the Internet) online intervention. They will spend 1-2 hours each week for 6-9 weeks completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the intervention, they will receive automated, tailored instructions for how to improve their sleep.
Receives: Behavioral: SHUTi (Sleep Healthy Using the Internet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SHUTi Engagement

    Level of SHUTi engagement: Core completion (i.e., nonuser [no cores completed], incomplete user [1-3 Cores], or complete user [4-6 Cores])

    Measured: 9-week Post-assessment

Secondary outcomes (2)

  1. Sleep-related Cognitions

    Dysfunctional Beliefs and Attitudes about Sleep; 16 items; sum scores range from 0 to 160 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)

    Measured: Baseline Pre-assessment and 9-week Post-assessment

  2. Sleep Self-efficacy

    Sleep Locus of Control Scale with two subscales:

    1. a 5-item subscale for internal locus of control; summed scores per scale range from 5 to 30 (higher scores indicate higher belief in the locus of control measured; higher internal sleep locus of control is a better outcome)
    2. a 3-item subscale for external locus of control; summed scores per scale range from 3 to 18 (higher scores indicate higher belief in the locus of control measured; lower external sleep locus of control is a better outcome)

    Measured: Baseline Pre-assessment and 9-week Post-assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start11 Jan 2022
  3. Primary completion6 Mar 2023
  4. Study completion19 Mar 2023

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986904
Sponsor's protocol ID
HSR210255
Other IDs
R21TR003522
Status last verified
Sep 2024
First submitted
16 Jul 2021
Last updated
23 Oct 2024
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified row-level data are available via data use agreement with the University of Virginia per institutional requirements; contact the primary investigator to initiate the contracting process.

Publications

  • Shaffer KM, Ritterband LM, You W, Buysse DJ, Mattos MK, Camacho F, Glazer JV, Klinger J, Donovan H. Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study. JMIR Res Protoc. 2022 Jan 12;11(1):e34792. doi: 10.2196/34792.

    PubMed 35019846

  • Shaffer KM, Ritterband LM, You W, Mattos MK, Buysse DJ, Glazer JV, Klinger J, Donovan H. Caregivers' Internet-Delivered Insomnia Intervention Engagement and Benefit: SHUTi-CARE Trial Primary Quantitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):645-657. doi: 10.1093/abm/kaae031.

    PubMed 38982942

  • Shaffer KM, Perepezko K, Glazer JV, Mattos MK, Klinger J, Buysse DJ, Ritterband LM, Donovan H. Caregiver Experiences With an Internet-Delivered Insomnia Intervention: SHUTi-CARE Trial Primary Qualitative Analysis. Ann Behav Med. 2024 Oct 16;58(10):658-669. doi: 10.1093/abm/kaae041.

    PubMed 38990523

Questions about this trial

What is this clinical trial studying?

A study testing SHUTi (Sleep Healthy Using the Internet) in people with Family Caregivers and Insomnia, run by University of Virginia at 2 sites 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 6 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 23 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 2 sites 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 23 Oct 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?

SHUTi Engagement (time frame: 9-week Post-assessment). 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 NCT04986904, which also lists 3 linked publications.

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 23 Oct 2024.

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