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Pain Self-management Program for Older Adults

19 novembre 2019 mis à jour par: University of Regina

A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery

It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services. The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance. Internet self-management programs have the potential to address pain undermanagement. As technology advances, the digital divide between the older and younger demographic continues to progress. Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats. The program was previously shown to be effective among younger persons but has not been tested with older adults.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.

A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.

Type d'étude

Interventionnel

Inscription (Réel)

121

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

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S 0A2
        • University of Regina

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

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • are residents of Canada
  • are 65 years of age or older
  • report experiencing pain for more than three months
  • are not experiencing very severe symptoms of depression or anxiety
  • have regular access to a computer and the internet
  • are proficient in writing and speaking the English language

Exclusion Criteria:

  • high suicide risk
  • concerns about online therapy
  • not present in the country during treatment
  • are younger than 65 years of age

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Online Group will receive access to the course on the computer (online). A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
Comportemental: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Expérimental: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Workbook Group will receive access to the course in a printed (workbook) format. A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
Comportemental: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
Aucune intervention: Wait List Control Group
Participants who are randomly allocated to the wait list control group will be provided access to the course after the twelve-week period has passed.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in the impact of pain in several areas of life
Délai: baseline, 8 weeks, 3 months
Measured by Pain Disability Index (PDI)
baseline, 8 weeks, 3 months
Change in depression
Délai: baseline, 8 weeks, 3 months
Measured by Geriatric Depression Scale-30 (GDS-30)
baseline, 8 weeks, 3 months
Change in anxiety
Délai: baseline, 8 weeks, 3 months
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
baseline, 8 weeks, 3 months
Change in chronic pain severity
Délai: baseline, 8 weeks, 3 months
Measured by Brief Pain Inventory (BPI)
baseline, 8 weeks, 3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Délai: baseline, 8 weeks, 3 months
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
baseline, 8 weeks, 3 months
Change in fear of movement or re-injury
Délai: baseline, 8 weeks, 3 months
Measured by TAMPA Scale of Kinesiophobia (TSK)
baseline, 8 weeks, 3 months
Change in acceptance of chronic pain
Délai: baseline, 8 weeks, 3 months
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
baseline, 8 weeks, 3 months
Change in tendency to amplify the threat value of constant pain
Délai: baseline, 8 weeks, 3 months
Measured by Pain Catastrophizing Scale (PCS)
baseline, 8 weeks, 3 months
Treatment satisfaction
Délai: 8 weeks
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
8 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Regina

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Les enquêteurs

  • Chercheur principal: Thomas Hadjistavropoulos, University of Regina
  • Chercheur principal: Heather Hadjistavropoulos, University of Regina

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 (Réel)

23 février 2018

Achèvement primaire (Réel)

20 avril 2019

Achèvement de l'étude (Réel)

20 avril 2019

Dates d'inscription aux études

Première soumission

18 avril 2018

Première soumission répondant aux critères de contrôle qualité

18 avril 2018

Première publication (Réel)

30 avril 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2018-004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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