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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.
The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting. Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique. The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible. If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. Wake Baptist may also develop its own web-based CBT for commercial use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Contact (Nurse) | Active Comparator | 6 regular telephone contacts by nurses who will use a motivational interviewing technique |
|
| E-mail contact | Active Comparator | 6 computer generated email reminders (control arm) over an 8-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-guided Web-based Cognitive Behavioral Therapy | Behavioral | nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome | Up to Week 16 |
| PROMIS Pain Interference | PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population. | Up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Completed Phone Calls | The number of completed phone calls by the nurse will be recorded. | Up to Week 16 |
| Completed Learning Modules Per Treatment Arm | The number of completed learning modules per treatment arm will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Interest in Pain Self-management | This refers to the acceptability a subject has to pain self management. This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?" |
Inclusion Criteria: -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Ang, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | United States |
If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. With assistance from Wake Forest Innovation, Wake Baptist may also develop its own web-based CBT that can be commercialize in the future.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nurse Support | Participants received phone-based coaching |
| FG001 | Control | No contact with the research team |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurse Support | Participants received phone-based coaching |
| BG001 | Control | No contact with the research team |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome | Posted | Mean | Standard Error | score on a scale | Up to Week 16 |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nurse Support | Participants received phone-based coaching | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis Ang, Primary Investigator | Wake Forest Health Sciences | 336-705-8701 | dang@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2020 | Jun 1, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2021 | May 5, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2020 | May 5, 2021 | ICF_002.pdf |
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Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique.
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Study coordinator will be blinded to randomization
| Week 16 |
| Up to Week 16 |
| Proportion of Patients Who Viewed Educational Video | This refers to the acceptability a subject has to watching the educational video on web-based CBT. This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (EMMI) divided by the number of patients who received the video from EMMI. | Up to Week 16 |
| Proportion of Subjects Who Called the Research Coordinator to Participate in the Study. | This refers to the acceptability a subject has to participating in the study. This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video. | Up to Week 16 |
| Ratings of Perceived Disruption | This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures | Up to Week 16 |
| Uptake Rates | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. For the uptake rate, the number of times participants log in to web-based CBT will be recorded. | Up to Week 16 |
| Self-report Frequency of Practicing Pain Coping Skills | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5. Higher scores denote better outcomes. | Up to Week 16 |
| Participant Overall Satisfaction on Web-based CBT Program | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Recorded in a question - scale 0-5. Higher scores denote better outcomes. | Up to Week 16 |
| Nurse's Time | This refers to the feasibility of the web-based CBT program. The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded. | Up to Week 16 |
| Perceived Work Rating | This refers to the feasibility of the web-based CBT program. Nurses will rate perceived additional work load. Recorded using sing a scale 1-5, higher scores denotes worse outcomes. | Up to Week 16 |
| Motivational Interviewing Treatment Integrity (MITI) Scale | This refers to the feasibility of the web-based CBT program. This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI). | Up to Week 16 |
| Mean Opioid Daily Dose | This refers to the burden or utilization of health care in relation to the web-based CBT program. The mean daily dose of opioids will be recorded for all participants. | Up to Week 16 |
| Non-study Phone Calls | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of pain relevant phone calls will be recorded. | Up to Week 16 |
| New Referrals to Other Musculoskeletal-related Specialties | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of new referrals to other musculoskeletal-related specialties will be recorded. | Up to Week 16 |
| Number of Emergency Room Visits Related to Pain | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of ER visits per subject related to pain will be recorded. | Up to Week 16 |
| PROMIS Physical Health -Fatigue | This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue. | Up to Week 16 |
| PROMIS Physical Health - Physical Function | This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment. | Up to Week 16 |
| PROMIS Physical Health - Sleep-related Impairment | This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment. | Up to Week 16 |
| PROMIS Physical Health- Pain Behavior | This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior. | Up to Week 16 |
| PROMIS Social Health | This is a questionnaire that pertains to subject social health. Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions. | Up to Week 16 |
| Brief Pain Inventory (BPI) Pain Severity | This is a pain severity questionnaire. BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score. | Up to Week 16 |
| BPI Pain Interference | This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items. | Up to Week 16 |
| Pain Catastrophizing Score (PCS) | This questionnaire shows the subject's perceived pain. The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome. | Up to Week 16 |
| Global Rating of Change (GRoC) | This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed. The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome. | Up to Week 16 |
| Patient Health Questionnaire Depression Scale (PHQ-8) | A questionnaire that shows patient's level of depression. Scores can be 0-24, with 0 being the best outcome and 24 being the worst. A score of 10 or greater is considered major depression. A score of 20 or more is severe major depression. | Up to Week 16 |
| Generalized Anxiety Disorder (GAD-7) | A questionnaire that shows how much anxiety a subject has. Scores can be 0-18. A score of 5-9 means mild anxiety. A score of 10-14 means moderate anxiety. A score of 15-18 means severe anxiety. | Up to Week 16 |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| PROMIS pain intensity | Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome | Mean | Standard Deviation | units on a scale |
|
| PROMIS pain interference | PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population. | Mean | Standard Deviation | T-Score |
|
| Participants |
|
|
| Primary | PROMIS Pain Interference | PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population. | Posted | Mean | Standard Error | T-score | Up to Week 16 |
|
|
|
| Secondary | Completed Phone Calls | The number of completed phone calls by the nurse will be recorded. | Posted | Median | Inter-Quartile Range | number of phone calls | Up to Week 16 |
|
|
|
| Secondary | Completed Learning Modules Per Treatment Arm | The number of completed learning modules per treatment arm will be recorded. | Posted | Median | Inter-Quartile Range | number of learning modules | Week 16 |
|
|
|
| Other Pre-specified | Proportion of Subjects With Interest in Pain Self-management | This refers to the acceptability a subject has to pain self management. This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?" | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Proportion of Patients Who Viewed Educational Video | This refers to the acceptability a subject has to watching the educational video on web-based CBT. This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (EMMI) divided by the number of patients who received the video from EMMI. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Proportion of Subjects Who Called the Research Coordinator to Participate in the Study. | This refers to the acceptability a subject has to participating in the study. This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Ratings of Perceived Disruption | This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Uptake Rates | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. For the uptake rate, the number of times participants log in to web-based CBT will be recorded. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Self-report Frequency of Practicing Pain Coping Skills | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5. Higher scores denote better outcomes. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Participant Overall Satisfaction on Web-based CBT Program | This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Recorded in a question - scale 0-5. Higher scores denote better outcomes. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Nurse's Time | This refers to the feasibility of the web-based CBT program. The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Perceived Work Rating | This refers to the feasibility of the web-based CBT program. Nurses will rate perceived additional work load. Recorded using sing a scale 1-5, higher scores denotes worse outcomes. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Motivational Interviewing Treatment Integrity (MITI) Scale | This refers to the feasibility of the web-based CBT program. This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI). | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Mean Opioid Daily Dose | This refers to the burden or utilization of health care in relation to the web-based CBT program. The mean daily dose of opioids will be recorded for all participants. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Non-study Phone Calls | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of pain relevant phone calls will be recorded. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | New Referrals to Other Musculoskeletal-related Specialties | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of new referrals to other musculoskeletal-related specialties will be recorded. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Number of Emergency Room Visits Related to Pain | This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of ER visits per subject related to pain will be recorded. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | PROMIS Physical Health -Fatigue | This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | PROMIS Physical Health - Physical Function | This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | PROMIS Physical Health - Sleep-related Impairment | This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | PROMIS Physical Health- Pain Behavior | This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | PROMIS Social Health | This is a questionnaire that pertains to subject social health. Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Brief Pain Inventory (BPI) Pain Severity | This is a pain severity questionnaire. BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | BPI Pain Interference | This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items. | Posted | Mean | Standard Error | score on a scale | Up to Week 16 |
|
|
|
| Other Pre-specified | Pain Catastrophizing Score (PCS) | This questionnaire shows the subject's perceived pain. The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Global Rating of Change (GRoC) | This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed. The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Patient Health Questionnaire Depression Scale (PHQ-8) | A questionnaire that shows patient's level of depression. Scores can be 0-24, with 0 being the best outcome and 24 being the worst. A score of 10 or greater is considered major depression. A score of 20 or more is severe major depression. | Not Posted | Up to Week 16 | Participants |
| Other Pre-specified | Generalized Anxiety Disorder (GAD-7) | A questionnaire that shows how much anxiety a subject has. Scores can be 0-18. A score of 5-9 means mild anxiety. A score of 10-14 means moderate anxiety. A score of 15-18 means severe anxiety. | Not Posted | Up to Week 16 | Participants |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control | No contact with the research team | 0 | 30 | 0 | 30 | 0 | 30 |
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