Trial Outcomes & Findings for Effect of Self-Management on Improving Sleep Apnea Outcomes (NCT NCT00310310)

Results Overview

The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

240 participants

Primary outcome timeframe

1 month

Results posted on

2017-04-20

Participant Flow

Participants were recruited and screened from the Pulmonary Sleep/CPAP Clinic at the Veterans Affairs San Diego Healthcare System (VASDHS). Project offices were based at the VASDHS HSR\&D unit.

Participant milestones

Participant milestones
Measure	Usual Care Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Overall Study STARTED	120	120
Overall Study COMPLETED	90	100
Overall Study NOT COMPLETED	30	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Self-Management on Improving Sleep Apnea Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=120 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=120 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.	Total n=240 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 12.5 • n=93 Participants	56.3 years STANDARD_DEVIATION 11.9 • n=4 Participants	56.2 years STANDARD_DEVIATION 12.2 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	116 Participants n=93 Participants	118 Participants n=4 Participants	234 Participants n=27 Participants
Region of Enrollment United States	120 participants n=93 Participants	120 participants n=4 Participants	240 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 month

The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
CPAP Adherence	2.8 hours per night Standard Deviation 2.6	3.9 hours per night Standard Deviation 2.4

PRIMARY outcome

Timeframe: 6 months

The investigators also examined the data obtained at the 6-month time point.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
CPAP Adherence	2.3 hours per night Standard Deviation 2.5	3.1 hours per night Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 Month

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score \> 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Pittsburgh Sleep Quality Index (PSQI)	8.5 units on a scale Standard Deviation 2.9	8.4 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 6 Months

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities. We had a few Veterans who skipped this assessment when filling out the project assessment packet.

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score \> 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Outcome measures

Outcome measures
Measure	Usual Care n=78 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=89 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Pittsburgh Sleep Quality Index (PSQI)	8.4 units on a scale Standard Deviation 3.6	8.3 units on a scale Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects. 1. A very large, All the time 2. A large 3. A moderate to large 4. A moderate 5. A small to moderate 6. A small 7. No, None, Not at all

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Sleep Apnea Quality of Life Index (SAQLI)	4.9 units on a scale Standard Deviation 1.04	5.1 units on a scale Standard Deviation 0.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations. The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions. The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity. The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Quality of Well Being Scale (QWB-SA)	0.56 units on a scale Standard Deviation 0.13	0.59 units on a scale Standard Deviation 014

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Self-Efficacy	3.9 units on a scale Standard Deviation 1.04	4.3 units on a scale Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Outcome Expectation	4.1 units on a scale Standard Deviation 0.9	4.5 units on a scale Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity. The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Center for Epidemiological Studies - Depression Scale (Short Form)	7.8 units on a scale Standard Deviation 5.9	7.2 units on a scale Standard Deviation 5.777

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: The target population for this study is all Veterans with OSA. It was expected that most participants would be middle-aged and older men and women, from a variety of ethnic backgrounds and with a full range of medical co-morbidities.

ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings. Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely). The situations are designed to vary in sleep-inducing capacity. The ESS scoring range is 0-24, with higher scores reflecting greater daytime sleepiness.

Outcome measures

Outcome measures
Measure	Usual Care n=90 Participants Usual sleep apnea and cpap care Usual care: Usual sleep apnea and cpap care	Self-Management n=100 Participants sleep apnea self-management program - 4 sessions, group-based Sleep Apnea Self-Management Program: Sleep apnea self-management program - 4 sessions, group-based.
Epworth Sleepiness Scale (ESS)	9.2 units on a scale Standard Deviation 4.8	8.1 units on a scale Standard Deviation 4.8

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carl J. Stepnowsky,PhD

VA San Diego Healthcare System

Phone: 858-642-1240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place