End Stage Renal DiseasePhase 2HOPENCT04571619
HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
A Phase 2 study testing Pain Coping Skills Training (PCST) and Buprenorphine in people with End Stage Renal Disease and Chronic Pain, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Pain, Opioid Dependence
- What is being tested?
- Pain Coping Skills Training (PCST) and Buprenorphine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 16 sitesUnited States
- Study dates
- 3 Jan 2021to 31 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing in-center maintenance hemodialysis for ≥90 days
- English- or Spanish-speaking
- 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
- Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4
- Willing to provide informed consent
- Willing to allow research team to obtain opioid pharmacy refill data
- Willing to allow research team to contact and work with their opioid prescriber
Who cannot join
- Current opioid use disorder
- Current use of heroin
- Current non-opioid substance use disorder with the exception of tobacco use disorder
- Current use of methadone, buprenorphine, or naltrexone for opioid use disorder
- Current receipt of hospice care
- Cognitive impairment that, in the judgement of the research team, precludes trial participation
Show all 13Show fewer
- Active suicidal intent
- Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder
- Life expectancy < 6 months
- Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months
- Current incarceration
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Illinois at Chicago
Chicago, Illinois, 60612
Dallas VA Medical Center
Dallas, Texas, 75216
Durham VA Healthcare System
Durham, North Carolina, 27705
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
West Virginia University
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University
New York, New York, 10010
VA NY Harbor Healthcare System
New York, New York, 10010
Rogosin Institute
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
VA Portland Healthcare System
Portland, Oregon, 97239
University of Washington
Seattle, Washington, 98104
West Haven VA Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis
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.
- Conditions
- End Stage Renal Disease, Chronic Pain, Opioid Dependence
- Being tested
- Pain Coping Skills Training (PCST), Buprenorphine
- Keywords
- hemodialysis, pain, opioids, pain coping skills
- Medical subject headings
- Kidney Failure, Chronic, Chronic Pain, Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Coping Skills Training (PCST)Behavioural
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.
BuprenorphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain Coping Skills Training | Active comparator | 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. Receives: Behavioral: Pain Coping Skills Training (PCST); Drug: Buprenorphine |
| Usual Care | Other | Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
Secondary outcomes (25)
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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
Measured: Weeks 12, 24, and 36
Number of Falls
Number of fall events per arm.
Measured: Throughout the 36-week follow-up
Rate of Falls
Event rate as calculated by number of falls/patient years
Measured: Though Week 36 follow-up
Number of Hospitalizations
Number of hospitalizations per arm.
Measured: Through 36-week follow-up
Rate of Hospitalizations
Event rate as calculated by number of hospitalizations/patient years
Measured: Through Week 36 follow-up
Number of Deaths
The number of deaths per arms.
Measured: Through the 36-week follow-up
Rate of Deaths
Rate of deaths as calculated by number of events/patient years
Measured: Through Week 36 follow-up
Buprenorphine Acceptability
The proportion of participants who initiate buprenorphine from among those offered buprenorphine.
Measured: Through Week 36
Buprenorphine Tolerability
The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance.
Measured: Through Week 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
Depression
Depression will be measured using the Patient Health Questionnaire (PHQ)-9. Lowest score - 0; Highest score - 27; Lower score equals better outcome.
Measured: Weeks 12, 24, and 36
Anxiety
Anxiety will be measured using the Generalized Anxiety Disorder (GAD)-7 questionnaire. Lowest score - 0; Highest score - 21; Lower score equals better outcome.
Measured: Weeks 12, 24, and 36
Coping
Coping will be measured using the 1-Item Coping Strategies Questionnaire (CSQ). Lowest score - 0; Highest score - 6; Lower score equals better outcome.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Weeks 12, 24, and 36
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.
Measured: Week 12, 24, 36
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.
Measured: Baseline, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start3 Jan 2021
- Primary completion21 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential multiple assignment design with a randomized component followed by a non-randomized component
- Masking
- None (open label)
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hennepin Health Care, New York University, Massachusetts General Hospital, University of Illinois 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
- Responsible party
- Sponsor
- Investigators
- Laura Dember, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571619
- Sponsor's protocol ID
- HOPE
- Other IDs
- U01DK123813, U01DK123786, U01DK123787, U01DK123812, U01DK123814, U01DK123816, U01DK123817, U01DK123818
- Acronym
- HOPE
- Status last verified
- Jun 2024
- First submitted
- 15 Sep 2020
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK) Central Repository after the trial has been completed.
Publications
Steel JL, Lockwood MB, Yabes JG, Hsu JY, Cavanaugh KL, Liebschutz JM, Unruh ML, Howell H, Brintz CE, Heapy A, Keefe F, Dember LM, Kimmel PL, Doorenbos A, Cheatle M, McNeil DW, Cukor D, Jhamb M; HOPE Consortium. Social determinants of health as predictors of latent symptom clusters in patients undergoing maintenance hemodialysis: A secondary analysis of the HOPE consortium randomized trial. J Pain. 2026 Jul 29;48:106313. doi: 10.1016/j.jpain.2026.106313. Online ahead of print.
PubMed 42526778Dember LM, Hsu JY, Mehrotra R, Cavanaugh KL, Kalim S, Charytan DM, Fischer MJ, Jhamb M, Johansen KL, Becker WC, Pellegrino B, Eneanya ND, Schrauben SJ, Pun PH, Unruh ML, Morasco BJ, Mehta M, Miyawaki N, Penfield J, Bernardo L, Brintz CE, Cheatle MD, Doorenbos AZ, Heapy AA, Keefe FJ, Krebs EE, Kuzla N, Nigwekar SU, Schmidt RJ, Steel JL, Wetmore JB, White DM, Kimmel PL, Cukor D; HOPE Consortium. Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140.
PubMed 39786400Steel JL, Brintz CE, Heapy AA, Keefe F, Cheatle MD, Jhamb M, McNeil DW, Shallcross AJ, Kimmel PL, Dember LM, White DM, Williams J, Cukor D. Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease. J Behav Med. 2025 Apr;48(2):298-307. doi: 10.1007/s10865-024-00534-x. Epub 2024 Dec 3.
PubMed 39627496Dember LM, Hsu JY, Bernardo L, Cavanaugh KL, Charytan DM, Crowley ST, Cukor D, Doorenbos AZ, Edwards DA, Esserman D, Fischer MJ, Jhamb M, Joffe S, Johansen KL, Kalim S, Keefe FJ, Kimmel PL, Krebs EE, Kuzla N, Mehrotra R, Mishra P, Pellegrino B, Steel JL, Unruh ML, White DM, Yabes JG, Becker WC; HOPE Consortium. The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis. Contemp Clin Trials. 2024 Jan;136:107409. doi: 10.1016/j.cct.2023.107409. Epub 2023 Dec 10.
PubMed 38086444
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT04571619
- Acronym / sponsor ID
- HOPE / HOPE
- Conditions
- End Stage Renal Disease, Chronic Pain, Opioid Dependence
- Keywords
- hemodialysis, pain, opioids, pain coping skills
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Hennepin Health Care, New York University, Massachusetts General Hospital, University of Illinois 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
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential multiple assignment design with a randomized component followed by a non-randomized component
| Arm | Type | Receives |
|---|---|---|
| Pain Coping Skills Training | Active comparator | Behavioral: Pain Coping Skills Training (PCST), Drug: BuprenorphineThe 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. |
| Usual Care | Other | Drug: BuprenorphineParticipants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Undergoing in-center maintenance hemodialysis for ≥90 days
- English- or Spanish-speaking
- 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
- Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4
Key exclusion criteria (13 listed)
- Current opioid use disorder
- Current use of heroin
- Current non-opioid substance use disorder with the exception of tobacco use disorder
- Current use of methadone, buprenorphine, or naltrexone for opioid use disorder
- Current receipt of hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pain Coping Skills Training |
| BuprenorphineAt 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. | Drug | Pain Coping Skills Training, Usual Care |
Primary outcome
Pain Interference
Time frame: 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.
25 secondary outcomes
Pain Intensity
Time frame: Weeks 12, 24, and 36
Pain Catastrophizing
Time frame: Weeks 12, 24, and 36
Opioid Use
Time frame: Weeks 12, 24, and 36
Number of Falls
Time frame: Throughout the 36-week follow-up
Rate of Falls
Time frame: Though Week 36 follow-up
Number of Hospitalizations
Time frame: Through 36-week follow-up
Rate of Hospitalizations
Time frame: Through Week 36 follow-up
Number of Deaths
Time frame: Through the 36-week follow-up
Rate of Deaths
Time frame: Through Week 36 follow-up
Buprenorphine Acceptability
Time frame: Through Week 36
Buprenorphine Tolerability
Time frame: Through Week 36
Overall Sense of Quality of Life
Time frame: Weeks 12, 24, and 36
Physical Functioning
Time frame: Weeks 12, 24, and 36
Depression
Time frame: Weeks 12, 24, and 36
Anxiety
Time frame: Weeks 12, 24, and 36
Coping
Time frame: Weeks 12, 24, and 36
Sleep Quality
Time frame: Weeks 12, 24, and 36
Fatigue
Time frame: Weeks 12, 24, and 36
Satisfaction With Treatment
Time frame: Weeks 12, 24, and 36
Social Support
Time frame: Weeks 12, 24, and 36
Family Intrusion
Time frame: Weeks 12, 24, and 36
Self-Efficacy
Time frame: Weeks 12, 24, and 36
Presence of Other Symptoms
Time frame: Weeks 12, 24, and 36
Severity of Other Symptoms
Time frame: Week 12, 24, 36
Discrimination
Time frame: Baseline, Week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42526778Steel JL, Lockwood MB, Yabes JG, Hsu JY, Cavanaugh KL, Liebschutz JM, Unruh ML, Howell H, Brintz CE, Heapy A, Keefe F, Dember LM, Kimmel PL, Doorenbos A, Cheatle M, McNeil DW, Cukor D, Jhamb M; HOPE Consortium. Social determinants of health as predictors of latent symptom clusters in patients undergoing maintenance hemodialysis: A secondary analysis of the HOPE consortium randomized trial. J Pain. 2026 Jul 29;48:106313. doi: 10.1016/j.jpain.2026.106313. Online ahead of print.
- Derived from this study: PubMed 39786400Dember LM, Hsu JY, Mehrotra R, Cavanaugh KL, Kalim S, Charytan DM, Fischer MJ, Jhamb M, Johansen KL, Becker WC, Pellegrino B, Eneanya ND, Schrauben SJ, Pun PH, Unruh ML, Morasco BJ, Mehta M, Miyawaki N, Penfield J, Bernardo L, Brintz CE, Cheatle MD, Doorenbos AZ, Heapy AA, Keefe FJ, Krebs EE, Kuzla N, Nigwekar SU, Schmidt RJ, Steel JL, Wetmore JB, White DM, Kimmel PL, Cukor D; HOPE Consortium. Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140.
- Derived from this study: PubMed 39627496Steel JL, Brintz CE, Heapy AA, Keefe F, Cheatle MD, Jhamb M, McNeil DW, Shallcross AJ, Kimmel PL, Dember LM, White DM, Williams J, Cukor D. Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease. J Behav Med. 2025 Apr;48(2):298-307. doi: 10.1007/s10865-024-00534-x. Epub 2024 Dec 3.
- Derived from this study: PubMed 38086444Dember LM, Hsu JY, Bernardo L, Cavanaugh KL, Charytan DM, Crowley ST, Cukor D, Doorenbos AZ, Edwards DA, Esserman D, Fischer MJ, Jhamb M, Joffe S, Johansen KL, Kalim S, Keefe FJ, Kimmel PL, Krebs EE, Kuzla N, Mehrotra R, Mishra P, Pellegrino B, Steel JL, Unruh ML, White DM, Yabes JG, Becker WC; HOPE Consortium. The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis. Contemp Clin Trials. 2024 Jan;136:107409. doi: 10.1016/j.cct.2023.107409. Epub 2023 Dec 10.
- Individual participant dataSharing planned: Yes. De-identified participant-level data will be transferred to the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK) Central Repository after the trial has been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dember, MD principal investigator
University of Pennsylvania
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pain Coping Skills Training (PCST) and Buprenorphine in people with End Stage Renal Disease and Chronic Pain, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Interference (time frame: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571619, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.