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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services is an important area of future research.
Insomnia is a common and distressing medical condition that affects nearly 20% of U.S. adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a community-based prospective observational study, preliminary data suggests that insomnia is associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy, stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators found a high prevalence of insomnia (80%) and were able to administer CBT-I in the participants' home via iPADs with wireless connectivity and secure video-chat software. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I without the added expense of an iPAD. The investigators are proposing to perform a non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based CBT-I that is performed in patients with insomnia who have been recently discharged from the hospital. The investigators will measure the following outcomes: insomnia severity index (primary outcome) and patient satisfaction. In the future, the investigators' program of research aims to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services.
Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on insomnia severity in recently hospitalized patients.
Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 3-points less than that in patients treated by conventional office-based CBT-I.
Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on patient satisfaction.
Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 1-point less than that in patients treated by conventional office-based CBT-I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional office-based CBT-I | Active Comparator | CBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist. |
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| Telemedicine based CBT-I | Experimental | The treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine CBT-I | Behavioral | Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem & 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period. | Baseline and after receiving CBT-I (~6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Consumer Assessment of Health Plans Survey (CAHPS v4.0) item | Health plan member's satisfaction with care on 0 to 10 scale (0 is the "worst " and 10 is the "best health plan possible"). Change in CAHPS score will be measured | Administered at baseline and at the end of receiving CBT-I (~6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Wake After Sleep Onset (WASO) | WASO is defined as the number of minutes spent awake after sleep onset. This is going to be measured by wrist actigraphy and sleep diaries. Change in WASO will be assessed over the intervention period | Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sairam Parthasarathy, MD | Contact | (520) 626-6109 | sparthasarathy@deptofmed.arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South) | Recruiting | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23423416 | Background | Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193. | |
| 19962922 | Background | Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Randomized Controlled Trial
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Observers will be blinded to subjects group assignment
| Conventional office-based CBT-I | Behavioral | Conventional office-based CBT-I |
|
| Sleep Onset Latency (SOL) |
SOL is the number of minutes that it takes to fall asleep. This is going to be measured by wrist actigraphy and sleep diaries. Change in SOL will be assessed over the intervention period |
| Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks) |
| Pittsburgh Sleep Quality Index (PSQI) | Provides a subjective assessment of sleep quality. Change in PSQI score will be assessed between baseline and 6-week follow-up. | Administered at baseline and at the end of receiving CBT-I (~6 weeks) |
| SF-36 Health Survey | A 36 item health status assessment tool, which measures general health and quality of life. Change in various dimensions of the SF-36 will be assessed over the 6-week period. | Administered at baseline, at the end of receiving CBT-I (~6 weeks), at 2 weeks following treatment, and at 12 weeks following treatment |
| Re-hospitalizations | Composite number of hospital readmissions over 6 weeks. | Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks) |
| Healthcare utilization | Composite number of visits to any of the following locations of healthcare service for care delivery: Emergency room, urgent care, as well as unscheduled and scheduled clinic visits. | Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks) |
| Epworth Sleepiness Scale (ESS) | A measure of sleepiness. Change in ESS score will be assessed | Administered at baseline and at the end of receiving CBT-I (~6 weeks) |
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| D001523 |
| Mental Disorders |