User Guide with Prompts for Chronic Pain

Overseen By Julie Postma, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Medical, psychological conditions, planned surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

100 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment User guide with prompts for chronic pain?

The research highlights the importance of effective communication between patients and providers in managing chronic pain, suggesting that tools improving this communication can enhance pain management. Additionally, continuous improvement methods, which involve patient education and regular pain assessment, have been shown to improve pain management and patient care quality. ^{1 2 3 4 5}

What safety data exists for treatments evaluated under different names, including 'User guide with prompts', for chronic pain?

Older adults taking pain relievers for chronic pain are at increased risk for adverse drug events (ADEs), which are unwanted side effects from medications. A study found that these individuals often experience ADEs and take various actions in response to them. ^{6 7 8 9 10}

How does the 'User Guide with Prompts' treatment for chronic pain differ from other treatments?

The 'User Guide with Prompts' treatment for chronic pain is unique because it likely involves using technology, such as voice assistants or electronic diaries, to help manage pain. This approach focuses on providing reminders and prompts to encourage self-management tasks, which can enhance accountability and independence, especially in older adults. ^{11 12 13 14 15}

What is the purpose of this trial?

A randomized controlled study will test whether adults with chronic pain have improved outcomes when receiving a User Guide and weekly prompts for a newly designed Online Pain-Management Resource when compared to an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include measures of activity, sleep, pain and level of use of the online pain-management resource.

Eligibility Criteria

This trial is for adults who suffer from chronic pain. Participants should be interested in managing their pain using online resources. There are no specific inclusion or exclusion criteria provided, but typically participants must meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

Interested in increasing activity level

Reside within the US

I have been experiencing chronic pain for at least 3 months.

Exclusion Criteria

Medical or psychological conditions that would prevent study participation

I have no upcoming surgeries that would stop me from joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a User Guide and weekly prompts to use an Online Pain-Management Resource or access to the resource without guidance

8 weeks

Weekly prompts (virtual)

Follow-up

Participants are monitored for changes in activity, sleep, and pain-related measures after treatment

4 weeks

Treatment Details

Interventions

• User guide with prompts

Trial Overview The study is testing if a User Guide with weekly prompts improves activity, sleep, and pain management for those using an Online Pain-Management Resource compared to those who just have access to the resource without additional guidance.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

The intervention group will receive a User Guide and weekly prompts with access to an Online Pain-Management Resource

Group II: Active-control Active Control 1 Intervention

The active-control group receives access to the Online Pain-Management Resource, but no User Guide or prompts.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Findings from Research

In a pilot survey of 22 older adults with chronic pain, gastrointestinal adverse drug events (ADEs) were the most commonly reported, with upset stomach being the most frequent issue, affecting 31.8% of participants.

Many older adults self-manage their analgesic-related ADEs without consulting their healthcare provider; 54.5% contacted their physician, while others changed their medication or stopped taking it altogether, highlighting the need for better communication about ADE management in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. McDonald, DD., Coughlin, S., Jin, C.[2019]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

In a 5-year study at a Finnish tertiary hospital, the Global Trigger Tool (GTT) identified 53 adverse drug events (ADEs) among 834 patient records, indicating a rate of 13 ADEs per 1000 patient-days and affecting 6% of patients.

The study found that as the number of medication-related triggers increased, so did the likelihood of experiencing an ADE, suggesting that the GTT medication module is useful for detecting potential risks, although modifications could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. Valkonen, V., Haatainen, K., Saano, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The chronic pain patient and functional assessment: use of the 6-Minute Walk Test in a multidisciplinary pain clinic. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Improving patient-provider communication about chronic pain: development and feasibility testing of a shared decision-making tool. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Core patient-reported outcome domains for routine clinical care in chronic pain management: patients' and healthcare professionals' perspective. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Exploratory factor analysis of the pain outcomes profile. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Refusing analgesics: using continuous improvement to improve pain management on a surgical ward. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Older Adults' Response to Analgesic Adverse Drug Reactions: A Pilot Study. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. [2023]

9. Brazil pubmed.ncbi.nlm.nih.gov

Proposal of a trigger tool to assess adverse events in dental care. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Standardized assessment of adverse events in rheumatology clinical trials: summary of the OMERACT 7 drug safety module update. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Voice Assistant Reminders for Pain Self-Management Tasks in Aging Adults. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Usability Study of the iACTwithPain Platform: An Online Acceptance and Commitment Therapy and Compassion-Based Intervention for Chronic Pain. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Frequent measurement of chronic pain: an electronic diary and empirical findings. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Design of a handheld electronic pain, treatment and activity diary. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Development of the Chronic Pain Coding System (CPCS) for Characterizing Patient-Clinician Discussions About Chronic Pain and Opioids. [2018]