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STUDY TITLE

• Formal Project Title: Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers
• Informal Project Title: SHUTi CARE - Sleep Healthy Using the Internet Caregiver Acceptability Research

OBJECTIVE

The long-term goal of this research is to improve the quality and impact of digital health interventions for caregivers, while reducing intervention development inefficiency – a goal identified as a high priority for current caregiver research. Towards that aim, the overall objective of this study is to determine what tailoring is necessary and sufficient to achieve optimal engagement with and efficacy of SHUTi for caregivers.

STUDY INFORMATION

Further study details may be found here:

• ClinicalTrials.gov Study Record (NCT04986904)
• IRB approvals:
  • UVA IRB HSR210255
  • Pitt ORP-IRB STUDY21080076

STUDY PUBLICATIONS

Published (peer-reviewed)

• Published study protocol
  • Citation: 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;11(1):e34792
  • Available online here; pdf file here

• Primary quantitative analysis

  • Citation: 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; https://doi.org/10.1093/abm/kaae031
  • Supplementary tables
  • Supplementary file

• Primary qualitative analysis

  • Citation: 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; https://doi.org/10.1093/abm/kaae041
  • Supplementary tables:
    • Supp Table 1
    • Supp Table 2
    • Supp Table 3
    • Supp Table 4
    • Supp Table 5

• Secondary qualitative analysis

  • Citation: Perepezko K, Gallagher V, Glazer J, Donovan H, Mattos M, Klinger J, Buysse D, Ritterband L, Shaffer K. "Better Sleep Means I'm Better Able to Provide Care": Caregivers' Perceived Impacts of an Internet-Delivered Insomnia Intervention. Int J Behav Med 2026; online here; pdf file here
  • Supplementary tables

STUDY MATERIALS

• Blank informed consent form
• Baseline Qualtrics Survey
• Post-assessment (Non-User) Qualtrics Survey
• Post-assessment (User) Qualtrics Survey
• Table of items and measures collected by study timepoint: SHUTi-CARE Assessment Table
• Study syntax files
  • Data Formatting (R), Sleep Diary Outcome Computation (R), and Primary Quantitative Manuscript (Stata) Syntax files available at study GitHub page
  • Qualtrics Data Formatting syntax PDF
  • Sleep Diary syntax PDF

• Qualitative analysis materials

  • Qualtrics coding form
  • Code book for matrix coding
  • Systematic member checking summary provided to participants for review

• Data files will be accessible with a Data Use Agreement via iTHRIV Data Commons

FUNDING

This trial is funded by the National Institutes of Health (NIH)–National Center for Advancing Translational Sciences (R21TR003522; principal investigator: Kelly Shaffer).