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- Essai clinique NCT00333619
Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting.
This project will be conducted in a VA post-acute rehabilitation site. Older veterans (>= 60 years) who were previously community-dwelling (N = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. Data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. Follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. The main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. Data will be analyzed for all randomized participants in an intention to treat analysis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Sepulveda, California, États-Unis, 91343
- VA Greater Los Angeles Healthcare System, Sepulveda, CA
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged > or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation
Exclusion Criteria:
- severe sleep apnea
- severe cognitive impairment
- not enrolled within one week of admission to rehabilitation unit
- too ill to participate
- and planned discharge to a nursing home for total nursing care
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Nonpharmacological sleep intervention
The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
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The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies
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Comparateur actif: Active control
Daily 15-minute social visit from a research assistant.
The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
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Daily 15-minute social visit from a research assistant.
The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pittsburgh Sleep Quality Index
Délai: 3-month follow-up
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The PSQI is a 18-item questionnaire that measures subjective sleep quality and sleep disturbances (total score ranging from 0 - 21; score > 8 indicates poor sleep quality).
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3-month follow-up
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Sleep Efficiency
Délai: 3-month follow-up
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Average sleep efficiency calculated from 7 days of actigraphy.
Sleep efficiency for each night is calculated as the number of hours asleep divided by the number of hours in bed.
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3-month follow-up
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Cathy A. Alessi, MD, VA Greater Los Angeles Healthcare System, Sepulveda, CA
Publications et liens utiles
Publications générales
- Martin JL, Jouldjian S, Mitchell MN, Josephson KR, Alessi CA. A longitudinal study of poor sleep after inpatient post-acute rehabilitation: the role of depression and pre-illness sleep quality. Am J Geriatr Psychiatry. 2012 Jun;20(6):477-84. doi: 10.1097/JGP.0b013e31824877c1.
- Skibitsky M, Edelen MO, Martin JL, Harker J, Alessi C, Saliba D. Can standardized sleep questionnaires be used to identify excessive daytime sleeping in older post-acute rehabilitation patients? J Am Med Dir Assoc. 2012 Feb;13(2):127-35. doi: 10.1016/j.jamda.2010.05.004. Epub 2010 Oct 2.
- Martin JL, Dzierzewski JM, Mitchell M, Fung CH, Jouldjian S, Alessi CA. Patterns of sleep quality during and after postacute rehabilitation in older adults: a latent class analysis approach. J Sleep Res. 2013 Dec;22(6):640-7. doi: 10.1111/jsr.12066. Epub 2013 Jul 8.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIR 04-321
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