Clinical trial NCT03267537: Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
Official title: Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Sleep
Telemedicine
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2017-08-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Medically ill patients with recent hospitalization who are being discharged to home.
* ISI score of \> 10 (chronic insomnia)
* Age \> 18 years
* Ability to provide informed consent
* Willingness to undergo sleep study

Exclusion Criteria:

* Presence of untreated sleep disorder that requires treatment independent of insomnia (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)
* Patients with severe debilitating neurological disease (end-stage Alzheimer's, large stroke, or other debilitating neurological disease) or any other condition that renders patients incapable of providing informed consent
* History of Bipolar disease; current or past (\< 6 months) history of suicidality or suicidal ideation
* Active substance abuse or alcoholism
* Pregnancy or lactation

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline and after receiving CBT-I (~6 weeks)
Secondary outcomes:
measure: Consumer Assessment of Health Plans Survey (CAHPS v4.0) item
timeFrame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
Other outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
measure: Sleep Onset Latency (SOL)
timeFrame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
measure: SF-36 Health Survey
timeFrame: Administered at baseline, at the end of receiving CBT-I (~6 weeks), at 2 weeks following treatment, and at 12 weeks following treatment
measure: Re-hospitalizations
timeFrame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
measure: Healthcare utilization
timeFrame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
Locations:
city: Tucson
country: United States
facility: University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South)
state: Arizona
Study officials:
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