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Effect of Self-Management on Improving Sleep Apnea Outcomes

22. mars 2017 oppdatert av: VA Office of Research and Development
Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background: Obstructive sleep apnea syndrome (OSA) is a common sleep disorder that is associated with serious medical and psychological complications. Nasal continuous positive airway pressure (CPAP) is the treatment of choice for this condition because it is highly effective in reducing the frequency of nocturnal respiratory events, improving sleep architecture, decreasing daytime sleepiness and improving blood pressure. Incomplete patient adherence, however, limits the effectiveness of CPAP therapy and results in sub-optimal patient outcomes. Previous efforts to enhance CPAP adherence have resulted in only modest improvements, have generally not been theory-driven, and have had minimal effects on key patient outcomes such as reduction in OSA symptoms or increase in health-related quality of life (HRQOL). The planned intervention in this proposal, the Sleep Apnea Self-Management Program (SASMP), is based on the rationale that sleep apnea is a chronic disease that requires significant self-care on the part of the patient. We draw on the extensive chronic disease self-management literature to provide a solid theoretical justification for this pragmatic intervention both to better manage key aspects of OSA and to increase CPAP adherence. Chronic disease management programs help reduce symptoms, improve HRQOL, improve treatment adherence, and decrease medical utilization. Objectives: The primary aim of this study is to compare the efficacy of the SASMP to Usual Care for improving OSA symptom status, HRQOL, and self-reported medical utilization. A second aim is to examine the extent to which changes in symptoms and HRQOL are mediated by changes in self-efficacy and CPAP adherence. Methods: We will evaluate the Sleep Apnea Self-Management Program (SASMP) by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group will attend 4 weekly educational sessions of 2.5 hours each. Two trained leaders facilitate the program from a scripted manual. Key topics covered in this program include 1) management of OSA symptoms, CPAP side effects, and weight loss; 2) maintaining social contacts and family relationships; and 3) dealing with symptoms of depression and worries about the future. Findings: No results at this time. Status: We are currently engaging in start-up activities. Impact: The results of this project can improve service delivery and improve health outcomes for sleep apnea patients at the Veterans Affairs San Diego Healthcare System, throughout the VA, as well as to any community based sleep clinic.

Studietype

Intervensjonell

Registrering (Faktiske)

240

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • California
      • San Diego, California, Forente stater, 92161
        • VA San Diego Healthcare System

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of obstructive sleep apnea
  • No previous use of CPAP
  • Must be a Veteran with residence within San Diego County

Exclusion Criteria:

  • Home oxygen therapy
  • Fatal comorbidities (i.e., life expectancy less than 6 mos)
  • Contraindications for CPAP use

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Usual Care
Usual sleep apnea and cpap care
Atferdsmessig: Usual care
Usual sleep apnea and cpap care
Eksperimentell: Self-Management
sleep apnea self-management program - 4 sessions, group-based
Atferdsmessig: Sleep Apnea Self-Management Program
Sleep apnea self-management program - 4 sessions, group-based.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CPAP Adherence
Tidsramme: 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.
1 month
CPAP Adherence
Tidsramme: 6 months
The investigators also examined the data obtained at the 6-month time point.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 1 Month

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.
1 Month
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 6 Months

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.
6 Months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sleep Apnea Quality of Life Index (SAQLI)
Tidsramme: 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
1 month
Quality of Well Being Scale (QWB-SA)
Tidsramme: 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).
1 month
Self-Efficacy
Tidsramme: 1 month

Social-cognitive theory (SCT) measure

1= Disagree Completely 5= Agree Completely 6= Not applicable
1 month
Outcome Expectation
Tidsramme: 1 month

Social-cognitive theory (SCT) measure

1= Not at all important 5= Extremely important 6= Not applicable
1 month
Center for Epidemiological Studies - Depression Scale (Short Form)
Tidsramme: 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.
1 month
Epworth Sleepiness Scale (ESS)
Tidsramme: 1 month
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.
1 month

Samarbeidspartnere og etterforskere

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Sponsor

VA Office of Research and Development

Etterforskere

  • Hovedetterforsker: Carl J Stepnowsky, PhD, San Diego Veterans Healthcare System

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2006

Primær fullføring (Faktiske)

1. mai 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

30. mars 2006

Først innsendt som oppfylte QC-kriteriene

30. mars 2006

Først lagt ut (Anslag)

3. april 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIR 02-275

Plan for individuelle deltakerdata (IPD)

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