The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).
CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested CBT-I mobile application paired with a wearable device (wrist actigraphy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs.
Sleep Health Education materials provided
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGAdherence
A Patient Adherence Form developed by the Veterans Affairs CBT-I Training Program will be used to assess adherence to the protocol. A mean adherence score across six domains showing good psychometric properties will be derived (0-24; higher represents more adherent)
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
Insomnia Severity
The Insomnia Severity Index (ISI) questionnaire will be used to determine the quality of sleep for patients (0 to 28; higher represents more severe insomnia symptoms)
Time frame: At screening, baseline, during dCBT-I/control, 2 weeks, 1- and 3-months after surgery
Sleep Diary Completion
The number of days of completed sleep diaries will be recorded.
Time frame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.
Homework Completion
The amount of time spent on CBT-I homework will be recorded.
Time frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
Utility
A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility)
Time frame: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.
Satisfaction with intervention
A 9-item survey will be used to assess which elements of the app were most helpful and the likelihood the patient would recommend it to family/friends.
Time frame: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.
Cognition
Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition
Time frame: At baseline and 2 weeks, 1- and 3-months after surgery
Pain severity
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity
Time frame: At baseline and 2 weeks, 1- and 3-months after surgery
Mood
The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms)
Time frame: At baseline and 1- and 3-months after surgery
Anxiety
Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms)
Time frame: At baseline and 1- and 3-months after surgery
Function
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function
Time frame: At baseline and 2 weeks, 1- and 3-months after surgery
Postoperative Delirium Incidence
The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients.
Time frame: From postoperative day 1 to postoperative day 3
Postoperative Delirium Severity
The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients.
Time frame: From postoperative day 1 to postoperative day 3
Delayed Neurocognitive Recovery
Using cognitive change from baseline (1 standard deviation from the mean).
Time frame: At 1-months after surgery
Postoperative Neurocognitive Disorders (NCD)
Using cognitive change from baseline (1 standard deviation from the mean).
Time frame: At 3-months after surgery
Sleep Efficiency
Actigraphy and diary-derived
Time frame: At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery
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