Trial · NCT04571619
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | Number of Falls | Throughout the 36-week follow-up | Number of fall events per arm. |
| Secondary | Rate of Falls | Though Week 36 follow-up | Event rate as calculated by number of falls/patient years |
| Secondary | Number of Hospitalizations | Through 36-week follow-up | Number of hospitalizations per arm. |
| Secondary | Rate of Hospitalizations | Through Week 36 follow-up | Event rate as calculated by number of hospitalizations/patient years |
| Secondary | Number of Deaths | Through the 36-week follow-up | The number of deaths per arms. |
| Secondary | Rate of Deaths | Through Week 36 follow-up | Rate of deaths as calculated by number of events/patient years |
| Secondary | Buprenorphine Acceptability | Through Week 36 | The proportion of participants who initiate buprenorphine from among those offered buprenorphine. |
| Secondary | Buprenorphine Tolerability | Through Week 36 | The proportion of patients who started buprenorphine and did not discontinue buprenorphine due to adverse effects or intolerance. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04571619/registered