Pain Self-management Program for Older Adults
19. november 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
121
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- University of Regina
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
|
|
Eksperimentel: 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.
|
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the impact of pain in several areas of life
Tidsramme: baseline, 8 weeks, 3 months
|
Measured by Pain Disability Index (PDI)
|
baseline, 8 weeks, 3 months
|
|
Change in depression
Tidsramme: baseline, 8 weeks, 3 months
|
Measured by Geriatric Depression Scale-30 (GDS-30)
|
baseline, 8 weeks, 3 months
|
|
Change in anxiety
Tidsramme: 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
Tidsramme: baseline, 8 weeks, 3 months
|
Measured by Brief Pain Inventory (BPI)
|
baseline, 8 weeks, 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Tidsramme: 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
Tidsramme: baseline, 8 weeks, 3 months
|
Measured by TAMPA Scale of Kinesiophobia (TSK)
|
baseline, 8 weeks, 3 months
|
|
Change in acceptance of chronic pain
Tidsramme: 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
Tidsramme: baseline, 8 weeks, 3 months
|
Measured by Pain Catastrophizing Scale (PCS)
|
baseline, 8 weeks, 3 months
|
|
Treatment satisfaction
Tidsramme: 8 weeks
|
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
|
8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Hadjistavropoulos, University of Regina
- Ledende efterforsker: Heather Hadjistavropoulos, University of Regina
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. februar 2018
Primær færdiggørelse (Faktiske)
20. april 2019
Studieafslutning (Faktiske)
20. april 2019
Datoer for studieregistrering
Først indsendt
18. april 2018
Først indsendt, der opfyldte QC-kriterier
18. april 2018
Først opslået (Faktiske)
30. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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