Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia

Insomnia Clinical Trial

Official title:

Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03267537
• Other study ID #: 1545864655443n/a
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2017
• Last updated: August 31, 2017
• Start date: June 13, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2017
• Source: University of Arizona
• Contact: Sairam Parthasarathy, MD
• Phone: (520) 626-6109
• Email: sparthasarathy[@]deptofmed.arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Telemedicine CBT-I
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
• Conventional office-based CBT-I
Conventional office-based CBT-I

Locations

Country	Name	City	State
United States	University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South)	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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)
Other	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)
Other	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)
Primary	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)
Secondary	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)