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Pain Self-management Program for Older Adults

19 november 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

121

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Experimenteel: 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.
Gedragsmatig: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the impact of pain in several areas of life
Tijdsspanne: baseline, 8 weeks, 3 months
Measured by Pain Disability Index (PDI)
baseline, 8 weeks, 3 months
Change in depression
Tijdsspanne: baseline, 8 weeks, 3 months
Measured by Geriatric Depression Scale-30 (GDS-30)
baseline, 8 weeks, 3 months
Change in anxiety
Tijdsspanne: 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
Tijdsspanne: baseline, 8 weeks, 3 months
Measured by Brief Pain Inventory (BPI)
baseline, 8 weeks, 3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Tijdsspanne: 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
Tijdsspanne: baseline, 8 weeks, 3 months
Measured by TAMPA Scale of Kinesiophobia (TSK)
baseline, 8 weeks, 3 months
Change in acceptance of chronic pain
Tijdsspanne: 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
Tijdsspanne: baseline, 8 weeks, 3 months
Measured by Pain Catastrophizing Scale (PCS)
baseline, 8 weeks, 3 months
Treatment satisfaction
Tijdsspanne: 8 weeks
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Regina

Medewerkers

Canadian Institutes of Health Research (CIHR)

Onderzoekers

  • Hoofdonderzoeker: Thomas Hadjistavropoulos, University of Regina
  • Hoofdonderzoeker: Heather Hadjistavropoulos, University of Regina

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 februari 2018

Primaire voltooiing (Werkelijk)

20 april 2019

Studie voltooiing (Werkelijk)

20 april 2019

Studieregistratiedata

Eerst ingediend

18 april 2018

Eerst ingediend dat voldeed aan de QC-criteria

18 april 2018

Eerst geplaatst (Werkelijk)

30 april 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 november 2019

Laatste update ingediend die voldeed aan QC-criteria

19 november 2019

Laatst geverifieerd

1 november 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2018-004

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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