Delayed Neurocognitive Recovery, Insomnia, Postoperative Delirium, Postoperative Neurocognitive Disorder
Conditions
Brief summary
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).
Detailed description
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).
Interventions
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.
BEHAVIORALSleep Health Education
Sleep Health Education materials provided
Sponsors
Massachusetts General Hospital
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 65 years old 2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) 3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire) 5\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.
Exclusion criteria
1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study 2. Rapidly progressive illnesses/life expectancy \<6 months 3. Active psychosis/suicidal ideation 4. Irregular shift work/sleep patterns 5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review 6. Sleep disorders other than insomnia or apnea 7. Cognitive impairment (diagnosis of dementia) 8. Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review) 9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence: CBT-I | After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. | 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) |
| Adherence: Sleep Diary/Actigraphy | Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery. | The number of days of completed sleep diaries and actigraphy will be recorded. |
| Adherence: Homework Completion | After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. | The amount of time spent on CBT-I homework will be recorded. |
| Insomnia Severity | At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery | The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to assess subjective sleep quality in patients (range 0 to 21; higher scores indicate worse sleep quality). |
| Utility | After dCBT-I intervention during Review session ~1 day to 1 week before surgery. | A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility) |
| Satisfaction with intervention | After dCBT-I intervention during Review session ~1 days to 1 week before surgery. | 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. |
| Cognition | At baseline and 2 weeks, 1- and 3-months after surgery | Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition |
| Pain severity and Function | At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity |
| Mood/Anxiety | At baseline and 1- and 3-months after surgery | The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms). Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms) |
| Postoperative Delirium Incidence | From postoperative day 1 to postoperative day 3 | The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients. |
| Postoperative Delirium Severity | From postoperative day 1 to postoperative day 3 | The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients. |
| Delayed Neurocognitive Recovery | At 1-months after surgery | Using cognitive change from baseline (1 standard deviation from the mean). |
| Postoperative Neurocognitive Disorders (NCD) | At 3-months after surgery | Using cognitive change from baseline (1 standard deviation from the mean). |
Countries
United States
Contacts
CONTACTAndrea Castillo, BS
CONTACTElesha McGrath, BS
STUDY_CHAIRLei Gao, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORKun Hu, PhD
Massachusetts General Hospital
Outcome results
None listed