Chronic Pain, End Stage Renal Disease, Opioid Dependence
Conditions
Keywords
hemodialysis, pain, opioids, pain coping skills
Brief summary
HOPE is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. The hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.
Interventions
BEHAVIORALPain Coping Skills Training (PCST)
The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.
DRUGBuprenorphine
At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Sponsors
Hennepin Health Care
New York University
Massachusetts General Hospital
University of Illinois at Chicago
University of Pittsburgh
University of Washington
University of New Mexico
Rogosin Institute
Vanderbilt University Medical Center
West Virginia University
Yale University
Durham VA Health Care System
VA Portland Healthcare System
West Haven VA Medical Center
University of Pennsylvania
Dallas VA Medical Center
VA New York Harbor Healthcare System
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential multiple assignment design with a randomized component followed by a non-randomized component
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Undergoing in-center maintenance hemodialysis for ≥90 days 3. English- or Spanish-speaking 4. Chronic pain defined as a response of Most days or Every day to the following question: In the past 3 months, how often have you had pain? Answer options: Never, Some days, Most days, Every day 5. Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4 6. Willing to provide informed consent 7. Willing to allow research team to obtain opioid pharmacy refill data 8. Willing to allow research team to contact and work with their opioid prescriber
Exclusion criteria
1. Current opioid use disorder 2. Current use of heroin 3. Current non-opioid substance use disorder with the exception of tobacco use disorder 4. Current use of methadone, buprenorphine, or naltrexone for opioid use disorder 5. Current receipt of hospice care 6. Cognitive impairment that, in the judgement of the research team, precludes trial participation 7. Active suicidal intent 8. Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder 9. Life expectancy \< 6 months 10. Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months 11. Current incarceration 12. Any other condition that the investigator considers precludes participation in the clinical trial Subgroup with Current or Recent Opioid Use During eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. The trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. The number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. If the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions. | Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support | Weeks 12, 24, and 36 | Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported. |
| Pain Intensity | Weeks 12, 24, and 36 | Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse. |
| Pain Catastrophizing | Weeks 12, 24, and 36 | Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse. |
| Opioid Use | Weeks 12, 24, and 36 | Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A |
| Number of Falls | Throughout the 36-week follow-up | Number of fall events per arm. |
| Rate of Falls | Though Week 36 follow-up | Event rate as calculated by number of falls/patient years |
| Number of Hospitalizations | Through 36-week follow-up | Number of hospitalizations per arm. |
| Rate of Hospitalizations | Through Week 36 follow-up | Event rate as calculated by number of hospitalizations/patient years |
| Number of Deaths | Through the 36-week follow-up | The number of deaths per arms. |
| Rate of Deaths | Through Week 36 follow-up | Rate of deaths as calculated by number of events/patient years |
| Buprenorphine Acceptability | Through Week 36 | The proportion of participants who initiate buprenorphine from among those offered buprenorphine. |
| Buprenorphine Tolerability | Through Week 36 | The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance. |
| Family Intrusion | Weeks 12, 24, and 36 | Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. |
| Physical Functioning | Weeks 12, 24, and 36 | Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome. |
| Depression | Weeks 12, 24, and 36 | Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome. |
| Anxiety | Weeks 12, 24, and 36 | Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome. |
| Coping | Weeks 12, 24, and 36 | Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome. |
| Sleep Quality | Weeks 12, 24, and 36 | Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. |
| Fatigue | Weeks 12, 24, and 36 | Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome. |
| Satisfaction With Treatment | Weeks 12, 24, and 36 | Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome. |
| Self-Efficacy | Weeks 12, 24, and 36 | Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Normalized score reported. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome. |
| Presence of Other Symptoms | Weeks 12, 24, and 36 | Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome. |
| Severity of Other Symptoms | Week 12, 24, 36 | Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome. |
| Discrimination | Baseline, Week 36 | Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome. |
| Overall Sense of Quality of Life | Weeks 12, 24, and 36 | Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome. |
Countries
United States
Participant flow
Recruitment details
643 participants were randomized across 16 recruitment sites.
Pre-assignment details
The original enrollment target was 640 participants. Permission to over-enroll was granted by the single IRB of record due to the nature of 16 recruitment sites enrolling simultaneously. The study teams did not want to have to exclude participants who had been consented and were in the screening process when the original target of 640 was reached. Therefore, 3 extra participants were enrolled as they had already been consented when the 640th participant was randomized.
Participants by arm
| Arm | Count |
|---|---|
| Pain Coping Skills Training Pain Coping Skills Training (PCST): The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish. | 319 |
| Usual Care Usual Care: Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. | 324 |
| Total | 643 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 | Death | 22 | 18 |
| Phase 1 | Withdrawal by Subject | 7 | 2 |
| Phase 2 | Death | 13 | 16 |
| Phase 2 | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | Pain Coping Skills Training | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 126 Participants | 130 Participants | 256 Participants |
| Age, Categorical Between 18 and 65 years | 193 Participants | 194 Participants | 387 Participants |
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12.6 | 60.4 years STANDARD_DEVIATION 12.5 | 60.3 years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 57 Participants | 119 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 256 Participants | 261 Participants | 517 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 12 Participants | 22 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 160 Participants | 148 Participants | 308 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 39 Participants | 41 Participants | 80 Participants |
| Race (NIH/OMB) White | 99 Participants | 111 Participants | 210 Participants |
| Region of Enrollment United States | 319 participants | 324 participants | 643 participants |
| Sex: Female, Male Female | 155 Participants | 138 Participants | 293 Participants |
| Sex: Female, Male Male | 164 Participants | 186 Participants | 350 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 35 / 319 | 34 / 324 |
| other Total, other adverse events | 102 / 319 | 115 / 324 |
| serious Total, serious adverse events | 169 / 319 | 167 / 324 |
Outcome results
Primary
Pain Interference
Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse.
Time frame: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
Population: Participants withdrew at various points during the trial. Some participants were not able to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Pain Interference | Baseline | 6.26 score on a scale | Standard Deviation 2.02 |
| Pain Coping Skills Training | Pain Interference | Week 12 | 5.09 score on a scale | Standard Deviation 2.37 |
| Usual Care | Pain Interference | Baseline | 6.45 score on a scale | Standard Deviation 2.13 |
| Usual Care | Pain Interference | Week 12 | 5.75 score on a scale | Standard Deviation 2.55 |
Secondary
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Anxiety | Baseline | 6.76 score on a scale | Standard Deviation 5.84 |
| Pain Coping Skills Training | Anxiety | Week 12 | 5.63 score on a scale | Standard Deviation 5.48 |
| Pain Coping Skills Training | Anxiety | Week 24 | 6.18 score on a scale | Standard Deviation 5.83 |
| Pain Coping Skills Training | Anxiety | Week 36 | 6.22 score on a scale | Standard Deviation 5.75 |
| Usual Care | Anxiety | Week 36 | 6.96 score on a scale | Standard Deviation 6.09 |
| Usual Care | Anxiety | Baseline | 7.38 score on a scale | Standard Deviation 6.14 |
| Usual Care | Anxiety | Week 24 | 7.48 score on a scale | Standard Deviation 5.89 |
| Usual Care | Anxiety | Week 12 | 7.04 score on a scale | Standard Deviation 6.03 |
Secondary
Buprenorphine Acceptability
The proportion of participants who initiate buprenorphine from among those offered buprenorphine.
Time frame: Through Week 36
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Buprenorphine Acceptability | .27 proportion of participants |
| Usual Care | Buprenorphine Acceptability | .50 proportion of participants |
Secondary
Buprenorphine Tolerability
The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance.
Time frame: Through Week 36
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Buprenorphine Tolerability | 1.00 proportion of participants |
| Usual Care | Buprenorphine Tolerability | .33 proportion of participants |
Secondary
Coping
Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points throughout the trial, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Coping | Baseline | 3.19 score on a scale | Standard Deviation 2.19 |
| Pain Coping Skills Training | Coping | Week 12 | 2.56 score on a scale | Standard Deviation 2.07 |
| Pain Coping Skills Training | Coping | Week 24 | 2.50 score on a scale | Standard Deviation 2.16 |
| Pain Coping Skills Training | Coping | Week 36 | 2.41 score on a scale | Standard Deviation 2.15 |
| Usual Care | Coping | Week 36 | 2.62 score on a scale | Standard Deviation 2.06 |
| Usual Care | Coping | Baseline | 3.50 score on a scale | Standard Deviation 2.29 |
| Usual Care | Coping | Week 24 | 2.86 score on a scale | Standard Deviation 2.11 |
| Usual Care | Coping | Week 12 | 2.90 score on a scale | Standard Deviation 2.11 |
Secondary
Depression
Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Depression | Baseline | 8.78 score on a scale | Standard Deviation 5.77 |
| Pain Coping Skills Training | Depression | Week 12 | 7.29 score on a scale | Standard Deviation 5.22 |
| Pain Coping Skills Training | Depression | Week 24 | 7.47 score on a scale | Standard Deviation 5.9 |
| Pain Coping Skills Training | Depression | Week 36 | 8.29 score on a scale | Standard Deviation 6.04 |
| Usual Care | Depression | Week 36 | 8.75 score on a scale | Standard Deviation 6.09 |
| Usual Care | Depression | Baseline | 9.51 score on a scale | Standard Deviation 6.11 |
| Usual Care | Depression | Week 24 | 8.96 score on a scale | Standard Deviation 5.72 |
| Usual Care | Depression | Week 12 | 8.92 score on a scale | Standard Deviation 5.83 |
Secondary
Discrimination
Discrimination will be measured using the Everyday Discrimination Scale Short Version (EDS-S). Lowest score - 0; Highest score - 5; Lower score equals better outcome.
Time frame: Baseline, Week 36
Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Discrimination | Baseline | 4.75 score on a scale | Standard Error 4.7 |
| Pain Coping Skills Training | Discrimination | Week 36 | 3.86 score on a scale | Standard Error 4.7 |
| Usual Care | Discrimination | Baseline | 4.76 score on a scale | Standard Error 4.95 |
| Usual Care | Discrimination | Week 36 | 4.18 score on a scale | Standard Error 5.23 |
Secondary
Family Intrusion
Family intrusion will be measured using the PROMIS Satisfaction with Social Roles and Activities. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Family Intrusion | Baseline | 42.8 T-score | Standard Deviation 9.29 |
| Pain Coping Skills Training | Family Intrusion | Week 12 | 44.4 T-score | Standard Deviation 9.71 |
| Pain Coping Skills Training | Family Intrusion | Week 24 | 45.1 T-score | Standard Deviation 9.67 |
| Pain Coping Skills Training | Family Intrusion | Week 36 | 44.5 T-score | Standard Deviation 10.3 |
| Usual Care | Family Intrusion | Week 36 | 42.9 T-score | Standard Deviation 9.77 |
| Usual Care | Family Intrusion | Baseline | 43.3 T-score | Standard Deviation 9.57 |
| Usual Care | Family Intrusion | Week 24 | 43.9 T-score | Standard Deviation 9.27 |
| Usual Care | Family Intrusion | Week 12 | 43.8 T-score | Standard Deviation 9.22 |
Secondary
Fatigue
Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Fatigue | Baseline | 59.0 t-score | Standard Deviation 10 |
| Pain Coping Skills Training | Fatigue | Week 12 | 56.2 t-score | Standard Deviation 11.4 |
| Pain Coping Skills Training | Fatigue | Week 24 | 56.6 t-score | Standard Deviation 12 |
| Pain Coping Skills Training | Fatigue | Week 36 | 57.0 t-score | Standard Deviation 11.1 |
| Usual Care | Fatigue | Week 36 | 57.5 t-score | Standard Deviation 10.8 |
| Usual Care | Fatigue | Baseline | 59.4 t-score | Standard Deviation 9.82 |
| Usual Care | Fatigue | Week 24 | 58.4 t-score | Standard Deviation 10.7 |
| Usual Care | Fatigue | Week 12 | 58.4 t-score | Standard Deviation 10.7 |
Secondary
Number of Deaths
The number of deaths per arms.
Time frame: Through the 36-week follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Number of Deaths | 35 deaths |
| Usual Care | Number of Deaths | 34 deaths |
Secondary
Number of Falls
Number of fall events per arm.
Time frame: Throughout the 36-week follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Number of Falls | 138 number of falls |
| Usual Care | Number of Falls | 155 number of falls |
Secondary
Number of Hospitalizations
Number of hospitalizations per arm.
Time frame: Through 36-week follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Number of Hospitalizations | 349 hospitalizations |
| Usual Care | Number of Hospitalizations | 313 hospitalizations |
Secondary
Opioid Use
Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A
Time frame: Weeks 12, 24, and 36
Population: Not all participants reported opioid use, as this was not an inclusion criterion but rather a subset of the study population. This outcome was assessed only for those participants reporting opioid use at the time of enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Opioid Use | Baseline | 45 morphine milliequivalents | Standard Deviation 148 |
| Pain Coping Skills Training | Opioid Use | Week 12 | 47 morphine milliequivalents | Standard Deviation 163 |
| Pain Coping Skills Training | Opioid Use | Week 24 | 48 morphine milliequivalents | Standard Deviation 165 |
| Pain Coping Skills Training | Opioid Use | Week 36 | 49 morphine milliequivalents | Standard Deviation 173 |
| Usual Care | Opioid Use | Week 36 | 27 morphine milliequivalents | Standard Deviation 43 |
| Usual Care | Opioid Use | Baseline | 24 morphine milliequivalents | Standard Deviation 36 |
| Usual Care | Opioid Use | Week 24 | 29 morphine milliequivalents | Standard Deviation 44 |
| Usual Care | Opioid Use | Week 12 | 32 morphine milliequivalents | Standard Deviation 53 |
Secondary
Overall Sense of Quality of Life
Quality of life will be measured using the Single-Item Quality of Life (QOL) Scale (SIS) from McGill Quality of Life (MQOL) questionnaire. Lowest score - 0; highest score - 10; Higher score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Overall Sense of Quality of Life | Baseline | 6.08 score on a scale | Standard Deviation 2.61 |
| Pain Coping Skills Training | Overall Sense of Quality of Life | Week 12 | 6.66 score on a scale | Standard Deviation 2.53 |
| Pain Coping Skills Training | Overall Sense of Quality of Life | Week 24 | 6.70 score on a scale | Standard Deviation 2.43 |
| Pain Coping Skills Training | Overall Sense of Quality of Life | Week 36 | 6.27 score on a scale | Standard Deviation 2.7 |
| Usual Care | Overall Sense of Quality of Life | Week 36 | 6.19 score on a scale | Standard Deviation 2.52 |
| Usual Care | Overall Sense of Quality of Life | Baseline | 5.82 score on a scale | Standard Deviation 2.68 |
| Usual Care | Overall Sense of Quality of Life | Week 24 | 6.09 score on a scale | Standard Deviation 2.46 |
| Usual Care | Overall Sense of Quality of Life | Week 12 | 5.88 score on a scale | Standard Deviation 2.54 |
Secondary
Pain Catastrophizing
Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Pain Catastrophizing | Baseline | 15.5 score on a scale | Standard Deviation 5.61 |
| Pain Coping Skills Training | Pain Catastrophizing | Week 12 | 13.3 score on a scale | Standard Deviation 6.14 |
| Pain Coping Skills Training | Pain Catastrophizing | Week 24 | 12.8 score on a scale | Standard Deviation 6.93 |
| Pain Coping Skills Training | Pain Catastrophizing | Week 36 | 12.8 score on a scale | Standard Deviation 6.68 |
| Usual Care | Pain Catastrophizing | Week 36 | 13.7 score on a scale | Standard Deviation 6.85 |
| Usual Care | Pain Catastrophizing | Baseline | 15.5 score on a scale | Standard Deviation 5.68 |
| Usual Care | Pain Catastrophizing | Week 24 | 14.2 score on a scale | Standard Deviation 6.37 |
| Usual Care | Pain Catastrophizing | Week 12 | 14.3 score on a scale | Standard Deviation 6.32 |
Secondary
Pain Intensity
Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points during the study. Some participants were not able to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Pain Intensity | Baseline | 5.83 score on a scale | Standard Deviation 2.05 |
| Pain Coping Skills Training | Pain Intensity | Week 12 | 4.95 score on a scale | Standard Deviation 2.32 |
| Pain Coping Skills Training | Pain Intensity | Week 24 | 4.64 score on a scale | Standard Deviation 2.44 |
| Pain Coping Skills Training | Pain Intensity | Week 36 | 4.74 score on a scale | Standard Deviation 2.49 |
| Usual Care | Pain Intensity | Week 36 | 5.10 score on a scale | Standard Deviation 2.46 |
| Usual Care | Pain Intensity | Baseline | 5.98 score on a scale | Standard Deviation 2.13 |
| Usual Care | Pain Intensity | Week 24 | 5.21 score on a scale | Standard Deviation 2.31 |
| Usual Care | Pain Intensity | Week 12 | 5.38 score on a scale | Standard Deviation 2.24 |
Secondary
Physical Functioning
Physical functioning will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form (SF)-6b questionnaire. Normalized score reported as t-values. The full range of possible scores is 21-59. 50 indicates the population mean with a standard deviation of 10. A higher score represents a better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Physical Functioning | Week 24 | 35.0 T-score | Standard Deviation 8.4 |
| Pain Coping Skills Training | Physical Functioning | Baseline | 33.5 T-score | Standard Deviation 7.6 |
| Pain Coping Skills Training | Physical Functioning | Week 36 | 34.9 T-score | Standard Deviation 7.89 |
| Pain Coping Skills Training | Physical Functioning | Week 12 | 35.5 T-score | Standard Deviation 8.08 |
| Usual Care | Physical Functioning | Week 36 | 34.5 T-score | Standard Deviation 8.47 |
| Usual Care | Physical Functioning | Week 12 | 33.9 T-score | Standard Deviation 7.59 |
| Usual Care | Physical Functioning | Baseline | 33.3 T-score | Standard Deviation 7.68 |
| Usual Care | Physical Functioning | Week 24 | 34.2 T-score | Standard Deviation 8.09 |
Secondary
Presence of Other Symptoms
Presence of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 30; Lower score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points during the study. Not all participants were able to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Presence of Other Symptoms | Baseline | 15.8 score on a scale | Standard Deviation 6.39 |
| Pain Coping Skills Training | Presence of Other Symptoms | Week 12 | 14.3 score on a scale | Standard Deviation 6.8 |
| Pain Coping Skills Training | Presence of Other Symptoms | Week 24 | 14.2 score on a scale | Standard Deviation 6.8 |
| Pain Coping Skills Training | Presence of Other Symptoms | Week 36 | 14.3 score on a scale | Standard Deviation 7.03 |
| Usual Care | Presence of Other Symptoms | Week 36 | 15.0 score on a scale | Standard Deviation 7.01 |
| Usual Care | Presence of Other Symptoms | Baseline | 16.5 score on a scale | Standard Deviation 6.45 |
| Usual Care | Presence of Other Symptoms | Week 24 | 15.8 score on a scale | Standard Deviation 6.68 |
| Usual Care | Presence of Other Symptoms | Week 12 | 15.8 score on a scale | Standard Deviation 6.38 |
Secondary
Rate of Deaths
Rate of deaths as calculated by number of events/patient years
Time frame: Through Week 36 follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Rate of Deaths | 0.17 deaths/patient year |
| Usual Care | Rate of Deaths | 0.15 deaths/patient year |
Secondary
Rate of Falls
Event rate as calculated by number of falls/patient years
Time frame: Though Week 36 follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Rate of Falls | 0.66 falls/patient year |
| Usual Care | Rate of Falls | 0.70 falls/patient year |
Secondary
Rate of Hospitalizations
Event rate as calculated by number of hospitalizations/patient years
Time frame: Through Week 36 follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pain Coping Skills Training | Rate of Hospitalizations | 1.67 hospitalizations/patient year |
| Usual Care | Rate of Hospitalizations | 1.42 hospitalizations/patient year |
Secondary
Satisfaction With Treatment
Satisfaction will be measured using the Patient Global Impression of Change (PGIC). Lowest score - 1; Highest score - 7; Lower score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various times throughout the trial, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Satisfaction With Treatment | Week 12 | 3.10 score on a scale | Standard Deviation 1.28 |
| Pain Coping Skills Training | Satisfaction With Treatment | Week 24 | 3.16 score on a scale | Standard Deviation 1.42 |
| Pain Coping Skills Training | Satisfaction With Treatment | Week 36 | 3.16 score on a scale | Standard Deviation 1.38 |
| Usual Care | Satisfaction With Treatment | Week 12 | 4.02 score on a scale | Standard Deviation 1.37 |
| Usual Care | Satisfaction With Treatment | Week 24 | 3.69 score on a scale | Standard Deviation 1.36 |
| Usual Care | Satisfaction With Treatment | Week 36 | 3.63 score on a scale | Standard Deviation 1.47 |
Secondary
Self-Efficacy
Self-efficacy will be measured using the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A and the Single item targeting self-efficacy for pain. PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8A: Lowest score - 8; Highest score - 40; Higher score equals better outcome. Normalized score reported. Single item targeting self-efficacy for pain: Lowest score - 0; Highest score - 100; Higher score equals better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various times during the study. Some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Self-Efficacy | Baseline | 45.4 score on a scale | Standard Deviation 8.11 |
| Pain Coping Skills Training | Self-Efficacy | Week 12 | 48.1 score on a scale | Standard Deviation 8.75 |
| Pain Coping Skills Training | Self-Efficacy | Week 24 | 48.3 score on a scale | Standard Deviation 9.17 |
| Pain Coping Skills Training | Self-Efficacy | Week 36 | 48.1 score on a scale | Standard Deviation 9.1 |
| Usual Care | Self-Efficacy | Week 36 | 47.2 score on a scale | Standard Deviation 8.75 |
| Usual Care | Self-Efficacy | Baseline | 45.1 score on a scale | Standard Deviation 8.32 |
| Usual Care | Self-Efficacy | Week 24 | 46.6 score on a scale | Standard Deviation 8.79 |
| Usual Care | Self-Efficacy | Week 12 | 46.2 score on a scale | Standard Deviation 7.55 |
Secondary
Severity of Other Symptoms
Severity of symptoms will be measured using the Dialysis Symptom Index (DSI) Symptom Subscale. Lowest score - 0; Highest score - 150; Lower score equals better outcome.
Time frame: Week 12, 24, 36
Population: Participants withdrew at various times during the trial. Not all participants were able to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Severity of Other Symptoms | Baseline | 55.2 score on a scale | Standard Deviation 27.5 |
| Pain Coping Skills Training | Severity of Other Symptoms | Week 12 | 48.4 score on a scale | Standard Deviation 28.3 |
| Pain Coping Skills Training | Severity of Other Symptoms | Week 24 | 48.9 score on a scale | Standard Deviation 28.9 |
| Pain Coping Skills Training | Severity of Other Symptoms | Week 36 | 48.7 score on a scale | Standard Deviation 28 |
| Usual Care | Severity of Other Symptoms | Week 36 | 51.9 score on a scale | Standard Deviation 29.1 |
| Usual Care | Severity of Other Symptoms | Baseline | 58.2 score on a scale | Standard Deviation 27.3 |
| Usual Care | Severity of Other Symptoms | Week 24 | 54.8 score on a scale | Standard Deviation 28 |
| Usual Care | Severity of Other Symptoms | Week 12 | 55.9 score on a scale | Standard Deviation 28.7 |
Secondary
Sleep Quality
Sleep quality will be measure using the PROMIS Sleep Disturbance Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 31.7 - 76.1. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various times during the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Sleep Quality | Baseline | 57.3 t-score | Standard Deviation 9.95 |
| Pain Coping Skills Training | Sleep Quality | Week 12 | 54.3 t-score | Standard Deviation 11.5 |
| Pain Coping Skills Training | Sleep Quality | Week 24 | 54.2 t-score | Standard Deviation 10.9 |
| Pain Coping Skills Training | Sleep Quality | Week 36 | 54.3 t-score | Standard Deviation 11.2 |
| Usual Care | Sleep Quality | Week 36 | 55.9 t-score | Standard Deviation 11.1 |
| Usual Care | Sleep Quality | Baseline | 58.2 t-score | Standard Deviation 10.3 |
| Usual Care | Sleep Quality | Week 24 | 56.8 t-score | Standard Deviation 10.3 |
| Usual Care | Sleep Quality | Week 12 | 57.4 t-score | Standard Deviation 9.94 |
Secondary
Social Support
Social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS). Lowest score - 1; Highest score - 7; Higher score is better and equals more support. Total score reported.
Time frame: Weeks 12, 24, and 36
Population: Participants withdrew at various points during the study, and some participants were unable to complete the PRO assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pain Coping Skills Training | Social Support | Baseline | 5.29 score on a scale | Standard Deviation 1.46 |
| Pain Coping Skills Training | Social Support | Week 12 | 5.37 score on a scale | Standard Deviation 1.41 |
| Pain Coping Skills Training | Social Support | Week 36 | 5.38 score on a scale | Standard Deviation 1.35 |
| Pain Coping Skills Training | Social Support | Week 24 | 5.43 score on a scale | Standard Deviation 1.33 |
| Usual Care | Social Support | Week 36 | 5.20 score on a scale | Standard Deviation 1.39 |
| Usual Care | Social Support | Week 12 | 5.18 score on a scale | Standard Deviation 1.42 |
| Usual Care | Social Support | Week 24 | 5.26 score on a scale | Standard Deviation 1.28 |
| Usual Care | Social Support | Baseline | 5.02 score on a scale | Standard Deviation 1.54 |