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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.
Participants with chronic pain will be randomized in this pilot study to an intervention group that receives a User Guide and weekly prompts to use an Online Pain-Management Resource or an active-control group that receives access to the Online Pain-Management Resource, but no User Guide or prompts. Outcomes of interest include:
i. Changes in activity and sleep over time when online resources are paired with using a wearable activity tracker (Fitbit Inspire 3®); ii. Self-reported pain and pain-related measures; and iii. Level of use of the online pain-management resource. All participants will also be asked to provide feedback on the online pain-management resource. The information collected throughout the study will inform the development team on the website's usefulness and whether guided use is superior to unguided self-directed use of the online pain resource.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will receive a User Guide and weekly prompts with access to an Online Pain-Management Resource |
|
| Active-control | Active Comparator | The active-control group receives access to the Online Pain-Management Resource, but no User Guide or prompts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| User guide with prompts | Behavioral | A user guide and prompts to assist use of an Online Pain-Management Resource |
|
| Measure | Description | Time Frame |
|---|---|---|
| Activity | Changes in activity as recorded on wearable activity tracker (Fitbit Inspire 3®) | 8 weeks |
| Sleep | Changes in sleep as recorded on wearable activity tracker (Fitbit Inspire 3®) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Patient reported outcomes measurement information system (PROMIS) Pain Intensity measures 1a and 3A where higher value means worse pain (1-5 rating). | 8 weeks |
| Pain Interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University College of Nursing | Spokane | Washington | 99201 | United States | ||
| Washington State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ruehlman, L.S., Bindler, R.J., Rangel, T.L. et al. Perspectives of Adults with Pain Regarding Online Pain Self-Management Resources. J. technol. behav. sci. (2024). https://doi.org/10.1007/s41347-024-00433-7 |
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Interested persons can contact the PI for deidentified data
After study ends for 3 years
People with a scientific rationale for requesting the information
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patient reported outcomes measurement information system (PROMIS) Pain Interference 8 item measure where higher value means worse pain (1-5 rating)
| 8 weeks |
| Chronic Pain Acceptance | Chronic Pain Acceptance Questionnaire is 14 items where 0=never true and 6=always true and higher scores indicate greater acceptance. | 8 weeks |
| Kinesiophobia | Tampa Scale of Kinesiophobia 17 items measures fear of movement and pain where 1=strongly disagree and 4=strongly agree. Higher scores indicate greater fear of movement and pain. A score of 37 or higher is often considered indicative of clinically significant kinesiophobia. | 8 weeks |
| Sleep disturbance | Patient reported outcome measurement information system (PROMIS) Sleep Disturbance Short Form 4a where 5= Very poor or not at all and 1= very good or very much. Higher scores indicate increased sleep disturbance. | 8 weeks |
| System Usability | Pain hub system usability scale 10 items rating 1-5 about the ease of system use. Higher scores are more favorable usability ratings. | 8 weeks |
| Client Satisfaction | Pain hub client satisfaction 8-item questionnaire rating items 1-4 where higher scores indicate greater satisfaction. | 8 weeks |
| Spokane |
| Washington |
| 99202 |
| United States |
| D001519 | Behavior |