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| Name | Class |
|---|---|
| Essentia Health | OTHER |
| Georgia State University | OTHER |
| Duke University | OTHER |
| Northwestern University |
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The RESOLVE study is a multicenter comparative effectiveness trial of two cognitive behavioral therapy-based chronic pain (CBT-CP) treatments delivered via telehealth modalities: 1) online program and 2) live, health coach-led, virtual sessions (telephone and/or video conference).
Specific Aims Aim #1: Determine the effectiveness of an online, CBT-based pain management program and virtual coach-led (telephonic/video) CBT-CP on achieving clinically meaningful improvements in patients' pain severity (pain intensity + pain-related interference) relative to those receiving usual care at 3 months.
1a. Examine the impact of the active interventions on secondary pain outcomes and related quality of life outcomes (social role functioning, physical functioning, and patient global impression of change); as well as exploratory outcomes, which include long-term opioid use; comorbid symptomology (depression, anxiety, and sleep disturbance); and high impact chronic pain and graded chronic pain.
1b. Conduct subgroup analyses to determine the impact of the active interventions on specific populations and explore for potential heterogeneity of treatment effects by sex; rural/medically underserved residency; multiple pain conditions; mental health mood disorders; and negative social determinants of health.
1c. Examine the role of theory-based mediators, pain catastrophizing, pain-related self-efficacy, and perceived support, on pain-severity.
Aim #2: Assess the cost and incremental cost-effectiveness of the online and virtual coach-led CBT-CP interventions compared to each other and usual care.
Aim #3: Conduct a qualitative evaluation to understand: 1) patient experiences of the interventions, including how they relate to treatment response, variability by site, and rural/medically underserved residency status; and 2) health system issues, including adaptations and contextual factors at the site and external levels, barriers and facilitators to intervention success and potential for adoption, sustainability and dissemination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online CBT-CP based program | Active Comparator | Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted) |
|
| Virtual health coach-led CBT-CP based program | Active Comparator | Live, health coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills (no usual care services restricted) |
|
| Usual Care plus information | No Intervention | Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online CBT-CP based program | Behavioral | Self-completed, online program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| MCID in Pain Severity at 6 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary) Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. |
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INCLUSION CRITERIA
Electronic Health Record-based inclusion criteria:
Patient-reported inclusion criteria:
EXCLUSION CRITERIA (patient-reported):
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| Name | Affiliation | Role |
|---|---|---|
| Lynn L DeBar, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Georgia, Center for Research and Evaluation | Atlanta | Georgia | 30309 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40699570 | Background | DeBar LL, Mayhew M, Wellman RD, Balderson BH, Dickerson JF, Elder CR, Justice M, Keefe FJ, McMullen CK, Owen-Smith AA, Rini C, Von Korff M, Waring S, Yarava A, Shen Z, Thompson RE, Clark AE, Casper TC, Cook AJ. Telehealth and Online Cognitive Behavioral Therapy-Based Treatments for High-Impact Chronic Pain: A Randomized Clinical Trial. JAMA. 2025 Jul 23;334(7):592-605. doi: 10.1001/jama.2025.11178. Online ahead of print. | |
| 36927459 |
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A releasable database containing underlying Individual Participant Data (IPD) from the primary outcomes manuscript and all National Institutes of Health (NIH) HEAL (Helping to End Addiction Long-term) Initiative common data elements will be produced and made broadly available through the NIH HEAL Initiative-designated central data repository. The database will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA) and in accordance to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects. Namely, all identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional or healthcare system identifiers.
The database will be released at the time of publication of the primary manuscript, or within 12 months of last patient procedure, whichever comes first. The duration of availability will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).
Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NIA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Online CBT-CP Based Program | Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| FG001 | Health Coach-led CBT-CP Based Program | Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| FG002 | Usual Care Plus Information | Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 2 individuals randomized in error are not reported/included in the Baseline Analysis Population as they were not eligible (i.e., 779 in the Usual Care Plus in the Participant Flow vs. 777 in Baseline Analysis Population).
The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were withdrawn immediately after randomization when the error was identified. That is why the Baseline Analytic Population = 2,331.
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| ID | Title | Description |
|---|---|---|
| BG000 | Online CBT-CP Based Program | Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| BG001 |
| 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 | Minimal Clinically Important Difference (MCID) in Pain Severity at 3 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. | Posted | Number | 95% Confidence Interval | Adjusted percentage of participants | Baseline to 3 months |
|
12-month study participation period
Severe Adverse Events, including death and hospitalizations, were systematically monitored.
Other Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
These events were monitored for the 2,331 eligible randomized participants. The 2 individuals who were randomized in error (i.e., totaling 2,333 in the Participant Flow) were not monitored for these events as they were withdrawn immediately after randomization when the error was identified.
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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 | Online CBT-CP Based Program | Self-completed, online cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant-reported adverse event | General disorders | Non-systematic Assessment | Non-serious adverse events (AEs) were not systematically collected and only ascertained via patient-initiated report, biasing collection to the intervention groups which had more staff contact. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan Mayhew | Kaiser Permanente | (564) 248-6303 | meghan.h.mayhew@kpchr.org |
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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 | Nov 10, 2022 | Apr 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2024 | Apr 29, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
The study uses a 3-arm, parallel intervention design; both intervention arms will be compared to usual care services.
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Primary and secondary outcome assessors will be masked to treatment assignment. It is not feasible for participants to be masked to treatment arm assignment due to the type of intervention. The PI and select Co-Investigators and study staff who are involved in the oversight and delivery of the interventions will also be aware of treatment assignment.
| Virtual health coach-led CBT-CP based program | Behavioral | Live, health coach-led program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based pain coping skills |
|
| Baseline to 6 months |
| MCID in Pain Severity at 12 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. | Baseline to 12 months |
| Pain Severity Score | Modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity | Baseline to 3, 6 and 12 months |
| Pain Intensity Score | 4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity | Baseline to 3, 6, and 12 months |
| Pain-related Interference Score | 7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference | Baseline to 3, 6 and 12 months |
| Social Role Functioning | PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in ability to participate. | Baseline to 3, 6 and 12 months |
| Physical Functioning | PROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in physical functioning. | Baseline to 3, 6 and 12 months |
| Patient Global Impression of Change (PGIC) - Pain | One item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain | Primary: Baseline to 3, 6 and 12 months |
| Patient Global Impression of Change (PGIC) - General | One item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status | Baseline to 3, 6 and 12 months |
| Essentia Institute of Rural Health |
| Duluth |
| Minnesota |
| 55805 |
| United States |
| Kaiser Permanente Northwest Center for Health Research | Portland | Oregon | 97227 | United States |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
| Background |
| Mayhew M, Balderson BH, Cook AJ, Dickerson JF, Elder CR, Firemark AJ, Haller IV, Justice M, Keefe FJ, McMullen CK, O'Keeffe-Rosetti MC, Owen-Smith AA, Rini C, Schneider JL, Von Korff M, Wandner LD, DeBar LL. Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Trials. 2023 Mar 16;24(1):196. doi: 10.1186/s13063-023-07165-8. |
| 42013134 | Derived | Cook AJ, Wellman RD, Mayhew M, Balderson BH, Justice M, Owen-Smith AA, Keefe FJ, Rini C, Von Korff M, DeBar LL. Predictors of patient treatment adherence and moderators of response for a randomized clinical trial comparing remote cognitive behavioral therapy approaches for high-impact chronic musculoskeletal pain. Pain. 2026 Jul 1;167(7):1657-1668. doi: 10.1097/j.pain.0000000000003971. Epub 2026 Apr 15. |
| Randomized in error |
|
| Health Coach-led CBT-CP Based Program |
Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| BG002 | Usual Care Plus Information | Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Rural/medically underserved residency | Count of Participants | Participants |
|
| OG001 | Health Coach-led CBT-CP Based Program | Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) |
| OG002 | Usual Care Plus Information | Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction |
|
|
|
| Secondary | MCID in Pain Severity at 6 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% decrease in score on modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF) from baseline (consistent with IMMPACT guidelines) (binary) Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. | Posted | Number | 95% Confidence Interval | Adjusted percentage of participants | Baseline to 6 months |
|
|
|
|
| Secondary | MCID in Pain Severity at 12 Months (Yes / No) | Minimal clinically important difference (MCID) in pain severity is defined as a 30% or greater improvement in pain severity score. [Pain severity score assessed via modified 11-item version of the BPI-SF from baseline (consistent with IMMPACT guidelines). The BPI-SF range= 0 to 10; higher score = worse pain severity.] MCID outcome is binary; reported as the adjusted percentage of participants with MCID (> or =30% improvement) in pain severity. | Posted | Number | 95% Confidence Interval | Adjusted percentage of participants | Baseline to 12 months |
|
|
|
|
| Secondary | Pain Severity Score | Modified 11-item version of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 11 items; range 0-10 with a higher score = worse pain severity | Posted | Mean | 95% Confidence Interval | Adjusted mean change (score on a scale) | Baseline to 3, 6 and 12 months |
|
|
|
|
| Secondary | Pain Intensity Score | 4-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of all 4 items; range 0-10 with a higher score = worse pain intensity | Posted | Mean | 95% Confidence Interval | Adjusted mean change (score on a scale) | Baseline to 3, 6, and 12 months |
|
|
|
|
| Secondary | Pain-related Interference Score | 7-item subscale of the Brief Pain Inventory - Short Form (BPI-SF). Score is calculated mean of 7 items; range 0-10 with a higher score = worse pain-related interference | Posted | Mean | 95% Confidence Interval | Adjusted mean change (score on a scale) | Baseline to 3, 6 and 12 months |
|
|
|
|
| Secondary | Social Role Functioning | PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a: Score by summing the 4 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better ability to participate in social roles and activities. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in ability to participate. | Posted | Mean | 95% Confidence Interval | Adjusted mean change (score on a scale) | Baseline to 3, 6 and 12 months |
|
|
|
|
| Secondary | Physical Functioning | PROMIS Physical Function - Short Form 6b: Score by summing the 6 items (each item response 1-5) and then converting raw score to standardized T-score, using the HealthMeasures Scoring Service, with mean of 50 and standard deviation of 10. Higher T-score= better physical functioning. Score ≤40 indicates moderate (40-30) to severe (< 30) limitations in physical functioning. | Posted | Mean | 95% Confidence Interval | Adjusted mean change (score on a scale) | Baseline to 3, 6 and 12 months |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) - Pain | One item assessing participant's perception of change in pain since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of pain | Posted | Mean | 95% Confidence Interval | Adjusted mean (score on a scale) | Primary: Baseline to 3, 6 and 12 months |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) - General | One item assessing participant's perception of change in overall status since start of study; range 1-7 (1=much better, 2=moderately better, 3=a little better, 4=No change, 5=a little worse, 6=moderately worse, 7=much worse). Higher score = worsening of overall status | Posted | Mean | 95% Confidence Interval | Adjusted mean (score on a scale) | Baseline to 3, 6 and 12 months |
|
|
|
|
| 3 |
| 776 |
| 55 |
| 776 |
| 1 |
| 776 |
| EG001 | Health Coach-led CBT-CP Based Program | Live, coach-led cognitive behavioral therapy for chronic pain (CBT-CP)-based skills training program delivered by telephone or videoconference in which participants complete eight, interactive sessions (approximately one per week) focused on training in one or more evidence-based CBT-CP skills (no usual care services restricted) | 7 | 778 | 65 | 778 | 16 | 778 |
| EG002 | Usual Care Plus Information | Receipt of a bound copy of the 2020 edition of the American Chronic Pain Association Resource Guide to Chronic Pain Management and any pharmacologic and nonpharmacologic treatments available to them without restriction | 7 | 777 | 63 | 777 | 0 | 777 |
|
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| Modified Poisson Regression |
Imputation, weighting and adjustment (see SAP) |
| <0.001 |
A priori threshold for statistical significance <0.05 |
| Relative Risk |
| 1.62 |
| 2-Sided |
| 95 |
| 1.39 |
| 1.90 |
| Superiority |
| Modified Poisson Regression | Imputation, weighting and adjustment (see SAP) | <0.001 | A priori threshold for statistical significance <0.05 | Relative Risk | 1.13 | 2-Sided | 95 | 0.98 | 1.30 | Superiority |
| Modified Poisson Regression |
Imputation, weighting and adjustment (see SAP) |
| <0.001 |
A priori threshold for statistical significance <0.05 |
| Relative Risk |
| 1.41 |
| 2-Sided |
| 95 |
| 1.25 |
| 1.59 |
| Superiority |
| Modified Poisson Regression | Imputation, weighting and adjustment | <0.001 | A priori threshold for statistical significance <0.05 | Relative Risk | 1.07 | 2-Sided | 95 | 0.96 | 1.19 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| <0.05 |
| Mean Difference (Final Values) |
| -0.4 |
| 2-Sided |
| 95 |
| -0.6 |
| -0.3 |
| Superiority |
| Baseline to 3 months | GEE, linear | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | <0.05 | Median Difference (Final Values) | -0.0 | 2-Sided | 95 | -0.2 | 0.1 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.6 | -0.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.7 | -0.4 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.3 | 0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.6 | -0.2 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.6 | -0.2 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.2 | 0.2 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -0.5 |
| -0.2 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.0 | 2-Sided | 95 | -0.2 | 0.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | -0.1 | Superiority | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.5 | -0.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.3 | 0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | -0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | -0.1 | Superiority | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.2 | 0.2 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| -0.5 |
| 2-Sided |
| 95 |
| -0.7 |
| -0.3 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.3 | 0.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.7 | -0.3 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -0.8 | -0.4 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.4 | 0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.7 | -0.3 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.7 | -0.3 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.2 | 0.2 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| 1.5 |
| 2-Sided |
| 95 |
| 0.8 |
| 2.2 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.7 | 2-Sided | 95 | 0.0 | 1.4 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 1.2 | 2-Sided | 95 | 0.4 | 1.9 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 1.5 | 2-Sided | 95 | 0.8 | 2.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.3 | 2-Sided | 95 | -0.4 | 1.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 1.3 | 2-Sided | 95 | 0.5 | 2.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 1.4 | 2-Sided | 95 | 0.6 | 2.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.7 | 0.9 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| 0.7 |
| 2-Sided |
| 95 |
| 0.2 |
| 1.2 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | 0.3 | 2-Sided | 95 | -0.2 | 0.8 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | 0.6 | 2-Sided | 95 | 0.1 | 1.2 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | 0.4 | 2-Sided | 95 | -0.1 | 0.9 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | -0.3 | 2-Sided | 95 | -0.8 | 0.3 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | 0.9 | 2-Sided | 95 | 0.3 | 1.5 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | 0.8 | 2-Sided | 95 | 0.2 | 1.4 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equation (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.7 | 0.5 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| -0.9 |
| 2-Sided |
| 95 |
| -1.0 |
| -0.8 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.3 | -0.1 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -0.8 | -0.5 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -0.8 | -0.5 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.2 | 0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -0.8 | -0.5 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -0.7 | -0.4 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.1 | 0.2 | Superiority |
|
| 12 months |
|
Baseline to 3 months
| GEE, linear |
| <0.05 |
Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -1.2 |
| -1.0 |
| Superiority |
| Baseline to 3 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.5 | -0.3 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.6 | -0.3 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -0.9 | -0.6 | Superiority |
| Baseline to 6 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | -0.1 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -0.7 | -0.4 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -0.8 | -0.5 | Superiority |
| Baseline to 12 months | GEE, linear | <0.05 | Imputation, weighting and adjustment (see SAP). Generalized estimating equations (GEE) | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.3 | 0.0 | Superiority |