COMMunication and Education for the New CPAP Experience (COMMENCE)
29 septembre 2017 mis à jour par: Faith Luyster, University of Pittsburgh
COMMENCE Study: COMMunication and Education for the New CPAP Experience
The purpose of this research study is to examine the effect of a couple-oriented education and support intervention on patient- and partner -reported outcomes (positive airway pressure (PAP) adherence) in patients newly diagnosed with obstructive sleep apnea (OSA).
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea (OSA), but adherence is poor.
CPAP adherence interventions to date have been met with limited success.
Intervention strategies would be optimized by added support for patients and alternative strategies for intervention delivery.
Significant others (SO) are likely to exert positive and negative effects on the patient's adoption and use of positive airway pressure (PAP) therapy and are frequently described as the greatest source of social support for patients with chronic illness.
Beginning the intervention before PAP initiation would capitalize on the teachable moment shortly following diagnosis when education and social support may be most essential.
The aims of the research plan are to examine the effects of a couple-oriented education and support intervention on patient- and partner-reported outcomes as compared to a patient-oriented education and support intervention and usual care and to examine the relationship between PAP adherence and patients' and partners' sleep quality and daytime functioning.
Patients in the pilot study will be randomized to the couple-oriented intervention, patient-oriented intervention, or standard clinical care group.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15261
- University of Pittsburgh
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Patient:
- Age is 21 years of age and older
- Have spouse or partner
- Polysomnographically (PSG) diagnosed OSA (AHI ≥ 5)
- Choice of continuous positive airway pressure (CPAP) as preferred treatment
Partner:
- Age is 18 years of age and older
- Have spouse or partner who has been diagnosed with OSA and has chosen CPAP as preferred treatment
Exclusion Criteria:
Patient:
- AHI < 5 on the diagnostic PSG
- Have a spouse or partner with OSA diagnosis and on OSA treatment
- Past treatment for OSA
- Diagnosis of a sleep disorder other than OSA that cause arousals from sleep (e.g., central sleep apnea, periodic limb movement disorder, insomnia)
- Diagnosis of a serious medical condition (e.g., end stage renal failure, severe chronic obstructive lung disease, severe asthma)
- History of or current diagnosis of a major psychiatric illness except depression (e.g., schizophrenia, bipolar disorder) partner:
- Have been diagnosed with OSA and using CPAP
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Patients in the Couple-oriented intervention
Patients randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with their partner and participate in an individual telephone follow-up session.
|
The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours.
This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise.
The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours.
The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise.
The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes.
This session will review CPAP usage and explore barriers and facilitators of CPAP use.
CPAP is treatment for obstructive sleep apnea.
CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
|
|
Autre: Patients in Usual Care
Patients will not attend any intervention sessions.
|
CPAP is treatment for obstructive sleep apnea.
CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
|
|
Expérimental: Patients in the Patient-oriented intervention
Patients randomly assigned to the patient-oriented (PT) group will attend two face to face sessions and participate in a telephone follow-up session.
|
CPAP is treatment for obstructive sleep apnea.
CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours.
This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise.
The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes.
The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise.
The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes.
This session will review CPAP usage and explore barriers and facilitators of CPAP use.
|
|
Expérimental: Partners in the Couple-oriented intervention
Partners randomly assigned to the couple-oriented (CO) group will attend two face to face sessions with the patient and participate in an individual telephone follow-up session.
|
The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours.
This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise.
The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours.
The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise.
The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes.
This session will review CPAP usage and explore barriers and facilitators of CPAP use.
|
|
Autre: Partners in Usual Care
Partners will not attend any intervention sessions.
|
No intervention will be received.
|
|
Expérimental: Partners in the Patient-oriented intervention
Partners randomly assigned to the patient-oriented (PT) group will not attend any intervention sessions.
|
The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours.
This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise.
The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes.
The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise.
The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes.
This session will review CPAP usage and explore barriers and facilitators of CPAP use.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Daytime Sleepiness
Délai: baseline and 3 months after CPAP initiation
|
The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24.
A score of > 10 indicates excessive daytime sleepiness.
|
baseline and 3 months after CPAP initiation
|
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Sleep-related Functional Outcomes
Délai: baseline and 3 months after CPAP initiation
|
The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living.
Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained.
Each domain score ranges from 1 to 4 (1 indicating more difficulty).
The total score is derived by calculating the mean of the domain scores and multiplying by five.
The total score ranges from 5 to 20, with higher scores indicating greater functioning.
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baseline and 3 months after CPAP initiation
|
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Sleep Quality
Délai: baseline and 3 months after CPAP initiation
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period.
The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
A global PSQI score is obtained by summing the 7 component scores (range = 0-21).
A PSQI global score > 5 indicates a poor sleeper.
|
baseline and 3 months after CPAP initiation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Continuous Positive Airway Pressure (CPAP) Adherence
Délai: one week, one month, and 3 months after CPAP initiation
|
Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure.
The latter number represents the amount of time power is on and the mask is positioned properly on the face.
All patients will be using a CPAP machine with remote monitoring capabilities.
Adherence reports are automatically uploaded to a secure data center daily.
Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.
|
one week, one month, and 3 months after CPAP initiation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Faith S Luyster, PhD, University of Pittsburgh
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Weaver TE, Maislin G, Dinges DF, Bloxham T, George CF, Greenberg H, Kader G, Mahowald M, Younger J, Pack AI. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007 Jun;30(6):711-9. doi: 10.1093/sleep/30.6.711.
- Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3.
- Weaver TE, Kribbs NB, Pack AI, Kline LR, Chugh DK, Maislin G, Smith PL, Schwartz AR, Schubert NM, Gillen KA, Dinges DF. Night-to-night variability in CPAP use over the first three months of treatment. Sleep. 1997 Apr;20(4):278-83. doi: 10.1093/sleep/20.4.278.
- Weaver TE, Laizner AM, Evans LK, Maislin G, Chugh DK, Lyon K, Smith PL, Schwartz AR, Redline S, Pack AI, Dinges DF. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep. 1997 Oct;20(10):835-43.
- Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007 Nov;133(6):920-54. doi: 10.1037/0033-2909.133.6.920.
- Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1096-100. doi: 10.1164/ajrccm.159.4.9808008.
- Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med. 2005 Oct 15;1(4):346-53.
- Stepnowsky CJ Jr, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med. 2002 May;3(3):239-47. doi: 10.1016/s1389-9457(01)00162-9.
- Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
- Cartwright R. Sleeping together: a pilot study of the effects of shared sleeping on adherence to CPAP treatment in obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):123-7.
- Baron KG, Smith TW, Berg CA, Czajkowski LA, Gunn H, Jones CR. Spousal involvement in CPAP adherence among patients with obstructive sleep apnea. Sleep Breath. 2011 Sep;15(3):525-34. doi: 10.1007/s11325-010-0374-z. Epub 2010 Jun 15.
- Baron KG, Smith TW, Czajkowski LA, Gunn HE, Jones CR. Relationship quality and CPAP adherence in patients with obstructive sleep apnea. Behav Sleep Med. 2009;7(1):22-36. doi: 10.1080/15402000802577751.
- Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4.
- Campos-Rodriguez F, Pena-Grinan N, Reyes-Nunez N, De la Cruz-Moron I, Perez-Ronchel J, De la Vega-Gallardo F, Fernandez-Palacin A. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005 Aug;128(2):624-33. doi: 10.1378/chest.128.2.624.
- Aloia MS, Di Dio L, Ilniczky N, Perlis ML, Greenblatt DW, Giles DE. Improving compliance with nasal CPAP and vigilance in older adults with OAHS. Sleep Breath. 2001;5(1):13-21. doi: 10.1007/s11325-001-0013-9.
- Aloia MS, Arnedt JT, Stanchina M, Millman RP. How early in treatment is PAP adherence established? Revisiting night-to-night variability. Behav Sleep Med. 2007;5(3):229-40. doi: 10.1080/15402000701264005.
- Engleman HM, Martin SE, Douglas NJ. Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Thorax. 1994 Mar;49(3):263-6. doi: 10.1136/thx.49.3.263.
- Pierce GR, Sarason IG, Sarason BR. General and relationship-based perceptions of social support: are two constructs better than one? J Pers Soc Psychol. 1991 Dec;61(6):1028-39. doi: 10.1037//0022-3514.61.6.1028.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2014
Achèvement primaire (Réel)
1 juillet 2016
Achèvement de l'étude (Réel)
1 juillet 2016
Dates d'inscription aux études
Première soumission
17 juin 2011
Première soumission répondant aux critères de contrôle qualité
17 juin 2011
Première publication (Estimation)
21 juin 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 septembre 2017
Dernière vérification
1 septembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1K23HL105887-01A1 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .