Study Summary
This study is evaluating whether a new digital pain management application may help improve pain management for individuals in hospice care.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 2-weeks post baseline
2-weeks post baseline
Adherence to pain management
Pain
Knowledge
Pain
Self-Efficacy
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard Care Condition
1 of 2
e-PainSupport Condition
1 of 2
Active Control
Experimental Treatment
396 Total Participants · 2 Treatment Groups
Primary Treatment: e-PainSupport · No Placebo Group · N/A
e-PainSupport Condition
Behavioral
Experimental Group · 1 Intervention: e-PainSupport · Intervention Types: BehavioralStandard Care ConditionNoIntervention Group · 1 Intervention: Standard Care Condition · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2-weeks post baseline
Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
529 Previous Clinical Trials
10,287,173 Total Patients Enrolled
17 Trials studying Pain
2,949 Patients Enrolled for Pain
Rush University Medical CenterLead Sponsor
390 Previous Clinical Trials
153,138 Total Patients Enrolled
3 Trials studying Pain
227 Patients Enrolled for Pain
Masako Mayahara, PhDPrincipal Investigator - Rush University Medical Center
Rush University Medical Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. A systematic evaluation of content, structure, and efficacy of interventions to improve patients' self-management of cancer pain. J Pain Symptom Manage. 2012 Aug;44(2):264-84. doi: 10.1016/j.jpainsymman.2011.08.015. Review.
- Kumar, SenthilP. 2011. “Utilization of Brief Pain Inventory as an Assessment Tool for Pain in Patients with Cancer: A Focused Review”. Indian Journal of Palliative Care. Scientific Scholar. doi:10.4103/0973-1075.84531.
- Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
- Bellg, Albert J., Treatment Fidelity Workgroup of the NIH Behavior Change Consortium, Belinda Borrelli, Barbara Resnick, Jacki Hecht, Daryl Sharp Minicucci, Marcia Ory, et al.. 2004. “Enhancing Treatment Fidelity in Health Behavior Change Studies: Best Practices and Recommendations from the NIH Behavior Change Consortium.”. Health Psychology. American Psychological Association (APA). doi:10.1037/0278-6133.23.5.443.
- Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74.
- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88.
- Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. Review.
- Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
- Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Letizia M, Creech S, Norton E, Shanahan M, Hedges L. Barriers to caregiver administration of pain medication in hospice care. J Pain Symptom Manage. 2004 Feb;27(2):114-24. doi: 10.1016/j.jpainsymman.2003.06.008.
- Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.
- Keefe FJ, Ahles TA, Porter LS, Sutton LM, McBride CM, Pope MS, McKinstry ET, Furstenberg CP, Dalton J, Baucom DH. The self-efficacy of family caregivers for helping cancer patients manage pain at end-of-life. Pain. 2003 May;103(1-2):157-62. doi: 10.1016/s0304-3959(02)00448-7.
- Dawson R, Sellers DE, Spross JA, Jablonski ES, Hoyer DR, Solomon MZ. Do patients' beliefs act as barriers to effective pain management behaviors and outcomes in patients with cancer-related or noncancer-related pain? Oncol Nurs Forum. 2005 Mar 5;32(2):363-74. doi: 10.1188/05.ONF.363-374.
- Kehl KA, Kowalkowski JA. A systematic review of the prevalence of signs of impending death and symptoms in the last 2 weeks of life. Am J Hosp Palliat Care. 2013 Sep;30(6):601-16. doi: 10.1177/1049909112468222. Epub 2012 Dec 12.
- Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019.
- Lind L, Karlsson D, Fridlund B. Patients' use of digital pens for pain assessment in advanced palliative home healthcare. Int J Med Inform. 2008 Feb;77(2):129-36. doi: 10.1016/j.ijmedinf.2007.01.013. Epub 2007 Mar 23.
- Bee PE, Barnes P, Luker KA. A systematic review of informal caregivers' needs in providing home-based end-of-life care to people with cancer. J Clin Nurs. 2009 May;18(10):1379-93. doi: 10.1111/j.1365-2702.2008.02405.x. Epub 2009 Apr 8.
- Chi NC, Demiris G. Family Caregivers' Pain Management in End-of-Life Care: A Systematic Review. Am J Hosp Palliat Care. 2017 Jun;34(5):470-485. doi: 10.1177/1049909116637359. Epub 2016 Mar 14.
- Kutner JS, Kassner CT, Nowels DE. Symptom burden at the end of life: hospice providers' perceptions. J Pain Symptom Manage. 2001 Jun;21(6):473-80. doi: 10.1016/s0885-3924(01)00281-0.
- Gunnarsdottir S, Serlin RC, Ward S. Patient-related barriers to pain management: the Icelandic Barriers Questionnaire II. J Pain Symptom Manage. 2005 Mar;29(3):273-85. doi: 10.1016/j.jpainsymman.2004.06.015.
- McMillan SC, Moody LE. Hospice patient and caregiver congruence in reporting patients' symptom intensity. Cancer Nurs. 2003 Apr;26(2):113-8. doi: 10.1097/00002820-200304000-00004.
- Lind L, Karlsson D. A system for symptom assessment in advanced palliative home healthcare using digital pens. Med Inform Internet Med. 2004 Sep-Dec;29(3-4):199-210. doi: 10.1080/14639230400005966.
- Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in patients with non-malignant terminal disease admitted to a hospice. Palliat Med. 2001 May;15(3):243-6. doi: 10.1191/026921601678576220.
- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Wilkie DJ, Judge MK, Berry DL, Dell J, Zong S, Gilespie R. Usability of a computerized PAINReportIt in the general public with pain and people with cancer pain. J Pain Symptom Manage. 2003 Mar;25(3):213-24. doi: 10.1016/s0885-3924(02)00638-3.
- Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006 Oct;29(5):489-97. doi: 10.1002/nur.20147.
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
- Koller A, Miaskowski C, De Geest S, Opitz O, Spichiger E. A systematic evaluation of content, structure, and efficacy of interventions to improve patients' self-management of cancer pain. J Pain Symptom Manage. 2012 Aug;44(2):264-84. doi: 10.1016/j.jpainsymman.2011.08.015.
- Masako Mayahara 2021. "The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04869085.
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