NCT02783365

Brief Summary

There are an estimated 100 million Americans with chronic pain. The enormity of the problem at the societal level is staggering, not simply in terms of its sheer prevalence but also the societal costs, including health care expenditures, disability compensation, lost productivity, and lost employment potential. The pharmacological focus in treatment tends to give patients with chronic pain a negative stereotype as many are viewed as drug seeking, or worse, they are perceived to have an imaginary illness. It is argued that these stigmas not only negatively affect the patients' healthcare experience, but also perpetuate maladaptive coping. In addition, it is suggested that reliance on pharmacological approaches have contributed to the rate of overdoses from prescribed opioids. In order to address this burden facing society, patients need opportunities to foster a sense of self-efficacy to manage their pain, as well as improve their healthcare experience by allowing them to dialogue with their clinician openly and freely about their chronic pain, and coping strategies. This study is designed to explore the impact of an intervention using photo-elicitation (based on Photovoice) and online group support (via Facebook) on participants' overall experience of chronic pain and patient-identified areas of function. Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them. This method serves as an empowering tool to connect participants to key stakeholders in the community, facilitates change and opportunities that otherwise would not be available to marginalized groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

3.2 years

First QC Date

May 17, 2016

Last Update Submit

September 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the score on the 3-item measure of chronic pain (PEG)

    The PEG asks 3 questions about (1) severity of pain on average in the past week, (2) how much has pain interfered with your life during the past week, and (3) how much has pain interfered with your general activity.

    Change from baseline to 12 months after enrollment

Secondary Outcomes (3)

  • Change in the score on the Pain Self-Efficacy Questionnaire (PSEQ)

    Change from baseline to 12 months after enrollment

  • Change in the score on the Chronic Pain Acceptance Questionnaire (CPAQ)

    Change from baseline to 12 months after enrollment

  • Change in score on a scale measuring the patient-centeredness of an office visit (Stewart et al., 2004)

    Change from baseline to 12 months after enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention uses photo-elicitation and online group support (via Facebook) to improve patients' overall experience of chronic pain and patient-identified areas of function. This intervention was informed by the Photovoice methodology developed by Wang and Burris (1994). Photovoice participants will utilize cameras that enable them to record issues related to their experiences, and subsequently display them in office visits with their physician or mid-level clinician.

Behavioral: Photo-elicitation and online group support

Control

NO INTERVENTION

Patients in the control practices will receive usual care and will be eligible to participate in the intervention after their participation in the study is completed at 12 months.

Interventions

See above information.

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will need to meet the following criteria in order to participate in the study:
  • they must be between the ages of 18-75
  • they must have an established care relationship with the practitioner (having had at least two previous visits for chronic pain of at least 6 months' duration)
  • they must read and understand English
  • they must be willing to sign a consent. Patients must have a device to take pictures (e.g., camera, phone, or tablet) and access to the internet in order to complete REDcap (the online data collection tool we will use to capture quantitative data in order to assess intervention impact), and participate in the online discussions via Facebook.

You may not qualify if:

  • No terminal illness, and/or a life expectancy of \< 1yr.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri, Dept. of Family and Community Medicine

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin H Crenshaw, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Family and Community Medicine

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 26, 2016

Study Start

July 1, 2016

Primary Completion

September 2, 2019

Study Completion

September 2, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

We will post de-identified data on an open-access website when the study is completed.

Locations