Tailoring a Sleep Health Enhancement Intervention for Older Adults to Address Frailty
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- semi-standardized qualitative interview
Study Overview
Brief Summary
The objective of the proposed study is to tailor a sleep health enhancement intervention to older adults and assess preliminary efficacy on reducing frailty in older adults. This pilot study will be conducted in two stages. In the treatment development stage, we will recruit n=10 older individuals age ≥65 with poor sleep health (≤ 7 on the Ru-SATED self-report questionnaire) to assess acceptability and tailor the sleep health enhancement intervention for older adults. In the pilot study stage to assess preliminary efficacy of the tailored sleep health enhancement intervention, n=30 older adults with poor sleep health will be randomly assigned to a 4-week 1x/week, telehealth-delivered sleep health enhancement intervention or to a wait-list control condition. Participants will wear wrist-worn actigraphy, complete sleep, frailty, and quality of life questionnaires at baseline and reassessments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •≥65 years old
- •≤ 7 on the RU-SATED self-report questionnaire
- •MMSE ≥25 and AD8 <3
Exclusion Criteria
- •Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- •>3 on the STOP BANG indicating increased risk of sleep apnea
- •Evidence of restless legs syndrome on RLS-Diagnosis Index
- •Evidence of circadian rhythm sleep-wake disorder
- •Evidence of parasomnia
- •Regular use (>2x/week) of prescription or over-the-counter medications to improve sleep
- •Score of ≥15 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorse any suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
- •Score of ≥10 on the Generalized Anxiety Disorder (GAD-7) indicating moderate to severe anxiety
- •Self-report of current or history (up to 2 years) of drug or alcohol abuse based on the DSM-V criteria
- •History of nervous system disorder such as stroke or Parkinson's disease
- •Severe mental illness such as schizophrenia or bipolar disorder
- •Current or history (within 5 years) of shift work including hours of midnight-4am
- •Is currently receiving a behavioral sleep health intervention
Arms & Interventions
Wait-List Control Group
The wait-list control group will be encouraged to continue with their usual activities and sleep habits during the wait period between baseline and reassessment and will undergo the sleep health enhancement intervention following the initial reassessment.
Sleep Health Enhancement Intervention
The sleep health enhancement intervention is a 4-week, 1x/week one-one-one program with a graduate research assistant who will be trained and supervised by the PI in provision of the sleep health enhancement intervention.
Intervention: Sleep Health Enhancement Intervention (Behavioral)
Outcomes
Primary Outcomes
semi-standardized qualitative interview
Time Frame: 6 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
6-item Acceptability Scale
Time Frame: 6 week
5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
WHOQOL-BREF
Time Frame: baseline, 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.
Ru_SATED sleep health composite
Time Frame: baseline, 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.
Tilburg Frailty Indicator
Time Frame: baseline, 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.
Secondary Outcomes
- Pittsburgh Sleep Quality Index(baseline, 6 week and 12 week reassessments)
- Epworth Sleepiness Scale(baseline, 6 week and 12 week reassessments)
- Dysfunctional Beliefs About Sleep(baseline, 6 week and 12 week reassessments)
- Actigraphy(baseline, 6 week and 12 week reassessments)
- Sleep Self-Efficacy(baseline, 6 week and 12 week reassessments)
Investigators
Catherine Siengsukon, PT, PhD
Professor
University of Kansas Medical Center