- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116621
N-of-1 Trials Using mHealth in Chronic Pain (PREEMPT)
N-of-1 Trials Using mHealth in Chronic Pain Aka PREEMPT (Personalized Research for Monitoring Pain Treatment)
Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a "trial and error" fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment.
The purpose of the PREEMPT Study is to test whether using a mobile phone application ("Trialist app") that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Mather, California, United States, 95655
- Veteran's Administration-Northern California Health Care System
-
Sacramento, California, United States, 95816
- University of California, Davis Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale
- Age 18-75 years
- Own web-enabled Android or iOS phone with data plan
- In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments
- Ability to speak and read English
Exclusion Criteria:
- Treated with surgery, radiation or chemotherapy for cancer in past 5 years
- Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety
- Pregnant or breastfeeding
- Dementia, bipolar disorder, schizophrenia, active suicidality
- Current alcohol or prescription drug abuse; history of disruptive behavior
- Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Trialist Intervention
Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain.
Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial.
After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.
|
Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
Other Names:
|
NO_INTERVENTION: Control-Usual Care
Receive usual care from clinician for chronic pain, do not use Trialist smartphone app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Time Frame: baseline, 26 weeks
|
Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain interference scores range from 0 - 100.
For pain interference, higher scores indicate greater pain interference.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
|
baseline, 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain interference scores range from 0 - 100.
For pain interference, higher scores indicate greater pain interference.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain intensity scores range from 0 - 100.
For pain intensity, higher scores indicate greater pain intensity.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components.
Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems.
The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components.
Global physical health measures overall physical health, physical function, pain and fatigue.
The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire
Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks.
Two questions comprised a subscale assessing overuse of medications.
Overuse scores range from 0 - 100.
Higher scores indicate greater adherence and less overuse of medications.
Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
|
Baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks.
Two questions comprised a subscale assessing underuse of medications.
Underuse scores range from 0-100.
Higher scores indicate greater adherence and less underuse of medication.
Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale
Time Frame: baseline, 13 weeks, 26 weeks, 52 weeks
|
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship.
Trust in physician scores range from 0 - 100.
Higher scores indicate greater patient trust in the clinician providing pain treatment.
Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
|
baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information
Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales.
Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment.
Satisfaction with pain information range from 0-100.
Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
|
Baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care
Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales.
Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain.
Satisfaction with medical care scores range from 0 - 100.
Higher scores indicate greater patient satisfaction with medical care.
Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
|
Baseline, 13 weeks, 26 weeks, 52 weeks
|
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication
Time Frame: Baseline, 13 weeks, 26 weeks, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales.
Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications.
Satisfaction with pain medication scores range from 0-100.
Higher scores indicate greater patient satisfaction with current pain medications.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
|
Baseline, 13 weeks, 26 weeks, 52 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain intensity scores range from 0 - 100.
For pain intensity, higher scores indicate greater pain intensity.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
|
Baseline, 26 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components.
Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems.
The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
|
Baseline, 26 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components.
Global physical health measures overall physical health, physical function, pain and fatigue.
The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
|
Baseline, 26 weeks
|
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks.
Two questions comprised a subscale assessing overuse of medications.
Overuse scores range from 0 - 100.
Higher scores indicate greater adherence and less overuse of medications.
Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
|
Baseline, 26 weeks
|
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks.
Two questions comprised a subscale assessing underuse of medications.
Underuse scores range from 0-100.
Higher scores indicate greater adherence and less underuse of medication.
Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
|
Baseline, 26 weeks
|
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks
Time Frame: Baseline, 26 weeks
|
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship.
Trust in physician scores range from 0 - 100.
Higher scores indicate greater patient trust in the clinician providing pain treatment.
Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
|
Baseline, 26 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks
Time Frame: Baseline, 26 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales.
Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment.
Satisfaction with pain information range from 0-100.
Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
|
Baseline, 26 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks
Time Frame: Baseline, 26 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales.
Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain.
Satisfaction with medical care scores range from 0 - 100.
Higher scores indicate greater patient satisfaction with medical care.
Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
|
Baseline, 26 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks
Time Frame: Baseline, 26 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales.
Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications.
Satisfaction with pain medication scores range from 0-100.
Higher scores indicate greater patient satisfaction with current pain medications.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
|
Baseline, 26 weeks
|
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks
Time Frame: 26 weeks
|
Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making.
Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months.
Medication related shared decision making scores range from 0-100.
Higher scores indicate more shared decision making.
|
26 weeks
|
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain interference scores range from 0 - 100.
For pain interference, higher scores indicate greater pain interference.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
|
Baseline, 13 weeks
|
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain intensity scores range from 0 - 100.
For pain intensity, higher scores indicate greater pain intensity.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
|
Baseline, 13 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components.
Global physical health measures overall physical health, physical function, pain and fatigue.
The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
|
Baseline, 13 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components.
Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems.
The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
|
Baseline, 13 weeks
|
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks.
Two questions comprised a subscale assessing overuse of medications.
Overuse scores range from 0 - 100.
Higher scores indicate greater adherence and less overuse of medications.
Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
|
Baseline, 13 weeks
|
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks.
Two questions comprised a subscale assessing underuse of medications.
Underuse scores range from 0-100.
Higher scores indicate greater adherence and less underuse of medication.
Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
|
Baseline, 13 weeks
|
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks
Time Frame: Baseline, 13 weeks
|
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship.
Trust in physician scores range from 0 - 100.
Higher scores indicate greater patient trust in the clinician providing pain treatment.
Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
|
Baseline, 13 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks
Time Frame: Baseline, 13 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales.
Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment.
Satisfaction with pain information range from 0-100.
Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
|
Baseline, 13 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks
Time Frame: Baseline, 13 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales.
Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain.
Satisfaction with medical care scores range from 0 - 100.
Higher scores indicate greater patient satisfaction with medical care.
Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
|
Baseline, 13 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks
Time Frame: Baseline, 13 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales.
Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications.
Satisfaction with pain medication scores range from 0-100.
Higher scores indicate greater patient satisfaction with current pain medications.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
|
Baseline, 13 weeks
|
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain interference scores range from 0 - 100.
For pain interference, higher scores indicate greater pain interference.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
|
Baseline, 52 weeks
|
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts.
The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Pain intensity scores range from 0 - 100.
For pain intensity, higher scores indicate greater pain intensity.
Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
|
Baseline, 52 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components.
Global physical health measures overall physical health, physical function, pain and fatigue.
The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
|
Baseline, 52 weeks
|
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components.
Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems.
The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10.
Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
|
Baseline, 52 weeks
|
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks.
Two questions comprised a subscale assessing overuse of medications.
Overuse scores range from 0 - 100.
Higher scores indicate greater adherence and less overuse of medications.
Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
|
Baseline, 52 weeks
|
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks.
Two questions comprised a subscale assessing underuse of medications.
Underuse scores range from 0-100.
Higher scores indicate greater adherence and less underuse of medication.
Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
|
Baseline, 52 weeks
|
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship.
Trust in physician scores range from 0 - 100.
Higher scores indicate greater patient trust in the clinician providing pain treatment.
Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
|
Baseline, 52 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks
Time Frame: Baseline, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales.
Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment.
Satisfaction with pain information range from 0-100.
Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
|
Baseline, 52 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks
Time Frame: Baseline, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales.
Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain.
Satisfaction with medical care scores range from 0 - 100.
Higher scores indicate greater patient satisfaction with medical care.
Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
|
Baseline, 52 weeks
|
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks
Time Frame: Baseline, 52 weeks
|
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales.
Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications.
Satisfaction with pain medication scores range from 0-100.
Higher scores indicate greater patient satisfaction with current pain medications.
Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
|
Baseline, 52 weeks
|
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks
Time Frame: Baseline, 52 weeks
|
Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making.
Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months.
Medication related shared decision making scores range from 0-100.
Higher scores indicate more shared decision making.
|
Baseline, 52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Barr C, Marois M, Sim I, Schmid CH, Wilsey B, Ward D, Duan N, Hays RD, Selsky J, Servadio J, Schwartz M, Dsouza C, Dhammi N, Holt Z, Baquero V, MacDonald S, Jerant A, Sprinkle R, Kravitz RL. The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial. Trials. 2015 Feb 27;16:67. doi: 10.1186/s13063-015-0590-8.
- Kravitz RL, Marois M, Sim I, Ward D, Kanekar SS, Yu A, Dounias P, Yang J, Wang Y, Schmid CH. Chronic pain treatment preferences change following participation in N-of-1 trials, but not always in the expected direction. J Clin Epidemiol. 2021 Nov;139:167-176. doi: 10.1016/j.jclinepi.2021.08.007. Epub 2021 Aug 14.
- Odineal DD, Marois MT, Ward D, Schmid CH, Cabrera R, Sim I, Wang Y, Wilsey B, Duan N, Henry SG, Kravitz RL. Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain: Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):102-111. doi: 10.1007/s11606-019-05303-0. Epub 2019 Aug 28.
- Kravitz RL, Schmid CH, Marois M, Wilsey B, Ward D, Hays RD, Duan N, Wang Y, MacDonald S, Jerant A, Servadio JL, Haddad D, Sim I. Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1368-1377. doi: 10.1001/jamainternmed.2018.3981.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 496804
- R01NR001938 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Pain
-
Sykehuset i Vestfold HFActive, not recruitingBack Pain | Musculoskeletal Pain | Chronic Pain | Musculoskeletal Diseases or Conditions | Pain, Chronic | Musculoskeletal Disorder | Musculoskeletal Neck PainNorway
-
University of Missouri, Kansas CityTerminatedOrthopaedic Related Pain (Musculoskeletal Pain)United States
-
Uppsala UniversityDalarna County Council, Sweden; Center for Clinical Research Dalarna, Sweden; REHSAM, SwedenTerminatedMusculoskeletal Neck Pain | Musculoskeletal Shoulder PainSweden
-
NORCE Norwegian Research Centre ASHelse Sor-Ost; Sykehuset i Vestfold HFCompletedNeck Pain Musculoskeletal | Back Pain Lower BackNorway
-
Stanford UniversityNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingPain | Joint Pain | Pain, Chronic | Chronic Musculoskeletal PainUnited States
-
Massachusetts General HospitalOrthopaedic Trauma AssociationCompleted
-
University of North Carolina, Chapel HillYale University; Duke University; National Institute on Aging (NIA); Indiana University and other collaboratorsCompletedChronic Pain | Acute Musculoskeletal PainUnited States
-
Wayne State UniversityUniversity of Southern CaliforniaCompleted
-
Wayne State UniversityUniversity of MichiganCompleted
Clinical Trials on smartphone
-
University of OklahomaWithdrawnRisk Reduction Behavior
-
Jordan University of Science and TechnologyNot yet recruitingUrinary IncontinenceJordan
-
University of WashingtonCompletedDepression | AnxietyUnited States
-
Kibi International UniversityCompleted
-
University Hospital, MontpellierCompleted
-
Linkoeping UniversityCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnMalignant Solid Neoplasm | Sarcoma | Hodgkin Lymphoma | Non-Hodgkin Lymphoma | Central Nervous System NeoplasmUnited States
-
Goalspal LLCRecruitingParkinson DiseaseUnited States
-
NHS Greater Glasgow and ClydeNot yet recruitingMemory Impairment | Stroke (CVA) or TIA
-
Gunma UniversityCompletedSubthreshold DepressionJapan