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Trial · NCT05968820

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary6-item Acceptability Scale6 week5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
Primarysemi-standardized qualitative interview6 week
Feasibility and acceptability will be assessed via semi-structured interview with a trained graduate research assistant following standard qualitative methods to determine attitudes, perceptions and experiences of effectiveness, potential barriers, benefits, and likes/dislikes of the sleep health enhancement intervention. The interview will be recorded for analysis purposes
PrimaryTilburg Frailty Indicatorbaseline, 6 week and 12 week reassessments
The Tilburg Frailty Indicator consists of 15 questions with score ranging from 0-15 with a higher score indicating higher level of frailty. The physical, psychological, and social frailty sub scores range from 0-8, 0-4, and 0-3 respectively.
PrimaryWHOQOL-BREFbaseline, 6 week and 12 week reassessments
The WHOQOL-BREF consists of 26 items and 4 domains of quality of life (psychological, physical health, social relationships and environmental). Scores range from 4-20 for each domain and a higher score indicates higher quality of life.
PrimaryRu_SATED sleep health compositebaseline, 6 week and 12 week reassessments
Ru-SATED sleep health composite will be calculated using actigraphy data and self-report questionnaires. The domains will be summed to create the composite sleep health score ranging from 0-6 with a higher score indicating better sleep health.
SecondaryPittsburgh Sleep Quality Indexbaseline, 6 week and 12 week reassessmentsScores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of \>5 indicates poor sleep quality.
SecondaryEpworth Sleepiness Scalebaseline, 6 week and 12 week reassessmentsConsists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
SecondaryDysfunctional Beliefs About Sleepbaseline, 6 week and 12 week reassessmentsThis assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
SecondarySleep Self-Efficacybaseline, 6 week and 12 week reassessmentsSleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
SecondaryActigraphybaseline, 6 week and 12 week reassessmentsParticipants will wear an actigraph on their non-dominant wrist for 7 nights
OtherTimed Up and Gobaseline, 6 week and 12 week reassessments
Timed Up and Go measures functional mobility and consists of sitting in a chair, standing up, walking 3-m, turning around, returning to the chair, and sitting down. The outcome is the time in seconds it takes to complete the task.
Other15 ft walk testbaseline, 6 week and 12 week reassessmentsThe test is performed in a hallway or open space, and the time it takes to walk 15 ft is noted in seconds.
Other6-Minute Walk Test (6MWT)baseline, 6 week and 12 week reassessments
The test is performed in a hallway or open space with two cones marking the turn-around points. The participant walks between the two cones for six minutes. Distance is measured by number of laps completed.
OtherGrip strength of the dominant and nondominant handbaseline, 6 week and 12 week reassessments
Grip strength of the dominant and nondominant hand will be assessed using a dynamometer with the participant seated, elbow flexed to 90 degrees, and arm by their side. The participant will perform one practice submaximal effort for acclimation followed by one maximal effort squeeze.
OtherThe Continuous Performance Test (CPT)baseline, 6 week and 12 week reassessments
The Continuous Performance Test (CPT) requires participants to respond as quickly and accurately as possible to a series of stimuli that are delivered via computer. The participants will be instructed to tap the space bar for every letter except "X." The participants' scores will be determined by their scores in detectability (e.g., difficulty differentiating targets from non-targets), error type (e.g., omissions, commissions, perseverations) and reaction time statistics.
OtherThe Stroop Testbaseline, 6 week and 12 week reassessments
The Stroop Test requires participants to inhibit the natural response (reading a word) and replace it with another response (saying a color). Each participant is given a list of X's printed in colored ink and a list of words printed in colored ink. The participant is instructed to name the color of the ink. They are given 45 seconds to name as many colors as they can. The reported outcome measure of this test is an interference score that is the difference between the two conditions while normalizing for number of x's using the following formulae: x-words/x.
OtherCognitive Failures Questionnaire (CFQ)baseline, 6 week and 12 week reassessments
Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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