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

August 31, 2017 updated by: Sairam Parthasarathy, University of Arizona
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional office-based CBT-I
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.
Behavioral: Conventional office-based CBT-I
Conventional office-based CBT-I
EXPERIMENTAL: Telemedicine based CBT-I
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: Baseline and after receiving CBT-I (~6 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consumer Assessment of Health Plans Survey (CAHPS v4.0) item
Time Frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wake After Sleep Onset (WASO)
Time Frame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
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)
Sleep Onset Latency (SOL)
Time Frame: Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)
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)
Time Frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
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
Time Frame: Administered at baseline, at the end of receiving CBT-I (~6 weeks), at 2 weeks following treatment, and at 12 weeks following treatment
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
Time Frame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
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
Time Frame: Administered at the time of hospital discharge and at the end of receiving CBT-I (~6 weeks)
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)
Time Frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
A measure of sleepiness. Change in ESS score will be assessed
Administered at baseline and at the end of receiving CBT-I (~6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

American Academy of Sleep Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 13, 2017

Primary Completion (ANTICIPATED)

May 31, 2019

Study Completion (ANTICIPATED)

May 31, 2019

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (ACTUAL)

August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1545864655443n/a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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