Sleep Health Enhancement in Older Adults to Address Frailty
- Conditions
- Frailty
- Interventions
- Behavioral: Sleep Health Enhancement Intervention
- Registration Number
- NCT05968820
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- ≥65 years old
- ≤ 7 on the RU-SATED self-report questionnaire
- MMSE ≥25 and AD8 <3
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Health Enhancement Intervention 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.
- Primary Outcome Measures
Name Time Method semi-standardized qualitative interview 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 6 week 5-point Likert scale on ease of use, understandability, enjoyment, perceived helpfulness, time commitment, and overall satisfaction
WHOQOL-BREF 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 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 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 Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index baseline, 6 week and 12 week reassessments Scores range from 0-21 with a higher score indicating a lower quality of sleep. A global score of \>5 indicates poor sleep quality.
Epworth Sleepiness Scale baseline, 6 week and 12 week reassessments Consists 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.
Dysfunctional Beliefs About Sleep baseline, 6 week and 12 week reassessments This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
Actigraphy baseline, 6 week and 12 week reassessments Participants will wear an actigraph on their non-dominant wrist for 7 nights
Sleep Self-Efficacy baseline, 6 week and 12 week reassessments Sleep 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.
Trial Locations
- Locations (1)
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
🇺🇸Kansas City, Kansas, United States