Contextual PGD for Pain Management in Older Adults

Overseen By Joshua D Judd, MBA BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Need legal representative

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve pain management for Veterans aged 65 and older who live with chronic pain. Researchers seek to determine how sharing personal health data, such as medication routines and home support, can help doctors create better care plans. Participants will share this information with their healthcare team either during their visit or at a later time. The goal is to determine if this data boosts patient satisfaction and adherence to treatment plans. Veterans dealing with ongoing pain who often rely on family or friends for daily help might be a good fit for this trial. As an unphased trial, this study offers Veterans a chance to contribute to innovative pain management strategies that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on understanding your pain management and care context rather than changing your medication.

What prior data suggests that this method is safe for pain management in older adults?

Research shows that using Contextual Patient Generated Data (PGHD) is generally safe for patients. PGHD involves collecting personal information about patients' daily lives and health management, helping doctors better understand a patient's situation. No reports of physical side effects exist because PGHD is not a drug or treatment; it is simply a method of gathering and sharing information.

Studies do not mention specific side effects because PGHD involves data collection, not medications or medical procedures. This simplicity makes participation easy, as it only requires sharing information about daily habits and routines.

Overall, PGHD is safe and enhances communication between patients and doctors, potentially leading to better pain management without direct health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Contextual Patient Generated Data for pain management in older adults because it offers a personalized approach that existing treatments like medications and physical therapy often lack. Unlike traditional treatments, this method involves patients contributing their own data about their pain experiences, which can lead to more tailored and effective pain management strategies. By integrating patient-generated data, healthcare providers can gain deeper insights into each individual's pain patterns, potentially leading to better outcomes. This innovative approach empowers patients and could transform how pain is understood and treated in older adults.

What evidence suggests that contextual patient generated data is effective for pain management in older adults?

Research has shown that using information from patients about their daily lives can greatly improve the management of chronic pain in older adults. In this trial, one group will contribute patient-generated health data (PGHD) available during study visits, while the control group may contribute PGHD available only to the provider in a subsequent visit. When patients share details about their everyday activities and support networks, doctors can create better care plans. This approach customizes treatments to fit each patient's specific needs, increasing satisfaction with care and adherence to plans. Early evidence suggests that including this kind of information in healthcare visits makes care more personal and effective, especially for managing pain. This method improves communication between patients and doctors, leading to better overall results. ^{1 2 4 6 7}

Who Is on the Research Team?

Jorie Butler, PhD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Are You a Good Fit for This Trial?

This trial is for Veterans aged 65 or older with chronic pain, their informal caregivers, and clinicians involved in their care. Participants must be within the Salt Lake City area. It's not suitable for Veterans who require a legal representative to consent.

Inclusion Criteria

I am 65 or older with chronic pain diagnosed by a doctor.

I am a healthcare provider for patients over 65 with chronic pain in the Salt Lake City area.

Veteran caregivers (including spouses, other relatives, or close friends involved in the daily life of the Veteran)

Exclusion Criteria

Veterans who need a legally authorized representative to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Usability Testing

Development of a prototype contextual PGHD profile display and evaluation of its usability through user-centered design sessions and simulation studies with clinicians.

6 months

Randomized Trial

Examine the impact of contextual PGHD profile displays on patient adherence, pain function, satisfaction, and shared decision making in a randomized trial.

2 years

Follow-up

Participants are monitored for adherence to the pain care plan and shared decision making outcomes.

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Contextual Patient Generated Data

Trial Overview The study tests how sharing contextual patient-generated data (like daily routines and support levels) affects satisfaction with care plans and adherence among elderly patients with chronic pain when this information is available during medical visits.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

This group will contribute PGHD and it will be available in the study visit.

Group II: Control Active Control 1 Intervention

This group may contribute PGHD but if so, it will not be available during a study visit, it will be available to the provider in a subsequent visit.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Citations

1. withpower.com withpower.com/trial/phase-9-2020-be6d6

Contextual PGD for Pain Management in Older Adults Trial Overview The study tests how sharing contextual patient-generated data (like daily routines and support levels) affects satisfaction with care plans and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10971637/

Patient-Generated Health Data (PGHD) - PubMed Central - NIH This article aims to thoroughly review and clarify PGHD by examining its origins, types, technological foundations, and the challenges it faces.

3. jmir.org jmir.org/2025/1/e57379/

Application of Patient-Generated Health Data Among Older ... Conclusions: This scoping review provides a comprehensive summary of the overall characteristics and use stages of PGHD in older adults with ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/20/NCT04560920/ICF_000.pdf

Enhancing Geriatric Pain Care with Contextual Patient ... Our study is about the use of Patient Generated Data (PGD) to enhance delivery of patient centered care to improve management of chronic pain in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985325/

Older Adult Perspectives on Integrative Pain Management ... Our objective was to explore older adult views on integrative pain management, specifically their educational needs and preferences, for patient-centered pain ...

6. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707434

IIR 19-265 – HSR Study - VA Health Systems Research The goal of this study is to refine and test an approach to create contextual Patient Generated Data (PGD) profiles to guide geriatric pain care.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0029655419300430

Patient generated health data use in clinical practice PGHD from self-tracking has been envisioned as a means to bridge a gap, supplementing data from clinical visits, with a rich picture of a person's daily ...