Pain Self-management Program for Older Adults

NCT ID: NCT03512522

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-23

Study Completion Date

2019-04-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A patient preference randomized controlled trial (RCT) will be used for this study. 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Online Group

Intervention Type BEHAVIORAL

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.

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.

Group Type EXPERIMENTAL

Workbook Group

Intervention Type BEHAVIORAL

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online Group

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.

Intervention Type BEHAVIORAL

Workbook Group

An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Regina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Hadjistavropoulos

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Heather Hadjistavropoulos

Role: PRINCIPAL_INVESTIGATOR

University of Regina

Locations

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University of Regina

Regina, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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2018-004

Identifier Type: -

Identifier Source: org_study_id

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