Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04221009 |
| Other study ID # |
N3303-P |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in
Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk
of poor health outcomes including cognitive impairment, declining mental health, poor
physical health, and premature mortality. Positive airway pressure (PAP) is the frontline
treatment for OSA that effectively reduces the many negative health consequences of the
disease. However, adherence to PAP is required to reap the therapeutic benefit.
Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with
moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is part of
the standard of care for OSA treatment with PAP, but on its own is insufficient for improving
PAP adherence. Alternatives to the standard of care include evidence-based behavioral
interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT)
which have been shown to increase PAP use and improve PAP adherence in persons without TBI.
Unfortunately, these evidence-based interventions (designed for cognitively intact
individuals) have not been adapted to address PAP adherence in persons with
moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is
to test the feasibility of a novel 4-session manualized intervention, designed with cognitive
accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and
OSA.
Study Aims: Study Aim 1 will test the feasibility and acceptability of delivering the PAP
adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process
measures. To date, no treatment exists to ameliorate the adverse consequences of
moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI,
which is a leading cause of long-term disability.
Method: In this study, 19 Veterans will be recruited from inpatient and outpatient TBI and
sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe
TBI; nonadherent to PAP, able to provide informed consent) will be invited to participate in
the 4-session intervention followed by a qualitative interview to inquire about intervention
acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be
administered pre- and post-intervention. Adherence will be measured via objective data from
hospital software which monitors PAP use.
Description:
Obstructive sleep apnea (OSA) is condition. The frontline treatment is Positive Airway
Pressure (PAP) therapy. Adherence to PAP is essential to reap the therapeutic benefit of the
treatment. Psychoeducation is part of the standard of care for the treatment of OSA, but on
its own has been shown to be ineffective in improving PAP adherence. In persons without brain
injury, alternatives to standard education, such as Motivational Interviewing (MI) and
Cognitive Behavioral Therapy (CBT), have been shown to improve PAP adherence. To date, no
published studies have examined maximizing frontline PAP treatment for persons with brain
injury. Therefore, the objective of this study is to develop and test the feasibility of a
manualized intervention, derived from evidence-based MI and CBT, and adapted with cognitive
accommodations, to maximize PAP success in Veterans with OSA and TBI-related burden.
This is a 2-year mixed methods study using quantitative and qualitative inquiry to determine
the feasibility and acceptability of a novel 4-session PAP adherence intervention (Aim 1).
Feasibility is the ease to which the intervention can be delivered (e.g., eligibility rates,
recruitment rates), and acceptability is the extent to which persons receiving the
intervention consider it appropriate (e.g., satisfaction ratings). Feasibility of process and
the ultimate outcome measures (e.g., completeness, perceived value and burden) will also be
examined (Aim 2).
Participants will be recruited from clinics within the James A. Haley Veterans' Hospital
(JAHVH), a tertiary care facility and teaching hospital. Participants will be recruited from
three clinical settings: (1) inpatient TBI neurorehabilitation; (2) outpatient TBI clinics;
and (3) sleep medicine clinic. Inclusion criteria for this study are as follows: (1)
moderate-to-severe TBI; (2) diagnosed with OSA and prescribed PAP therapy; (3) are
nonadherent to PAP treatment; and (4) able to consent. The plan is to enroll 19 participants,
because -- using a conservative 75% retention estimate - it is expected that 14 will complete
the intervention, exceeding the minimum for data saturation.
Upon receipt of consent, the pre-intervention study measures will be administered. Veterans
will be scheduled for four treatment sessions. After the final session, participants will
complete post-intervention measures. The intervention will be delivered by a doctoral level
psychologist. Two independent evaluators will listen to 20% of audio-recorded sessions and
conduct intervention fidelity checks using a Fidelity Rating Checklist created for this study
by the PI, and adapted from other rating MI and CBT fidelity forms. Of the recordings, 10%
will be the same session to conduct interrater reliability checks of the ratings.
Participants will be contacted within 15 business days of their last intervention session for
the qualitative interview to gather information on acceptability of the intervention. The
project manager/research assistant will download objective PAP adherence data from the PAP
software program during study pre-screening and 30 days following the last intervention
session, to permit evaluation of adherence.
Analysis will include examination of persons enrolled and retained versus study eligible, and
reasons for non-enrollment. Attendance will be described. Acceptability will be examined via
the post-intervention interview. Identification of themes will be generated from the analysis
using a constant comparative approach. The qualitative team will independently read the data,
assign labels and codes to data segments, and develop initial themes, then meet to develop
consensus on initial themes and codes, revising them using an iterative process, confirming
evidence and consider rival explanations that contrast with findings and conclusions. Study
measures. Pre- and post-intervention measures which will be examined for completeness.
Descriptive data will be presented (e.g., central tendency, variability, change scores, and
effect sizes).
