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Pain Self-management Program for Older Adults

U

University of Regina

Status

Completed

Conditions

Chronic Pain
Depression
Anxiety

Treatments

Behavioral: Online Group
Behavioral: Workbook Group

Study type

Interventional

Funder types

Other

Identifiers

NCT03512522
2018-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

121 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 3 patient groups

Online Group
Experimental group
Description:
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.
Treatment:
Behavioral: Online Group
Workbook Group
Experimental group
Description:
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.
Treatment:
Behavioral: Workbook Group
Wait List Control Group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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