The Use of a Digital Application for Reporting Pain and Pain Management in Home Hospice

NCT04869085 | Completed Results DMC

• 5 other identifiers: NCT048690855R21NR018952310245310244310243
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Poor adherence to pain management and high pain intensity associated with serious, advanced illness is a major public health concern. This randomized clinical trial will test the efficacy of a newly enhanced digital pain and pain management application (e-PainSupport) for use in a home hospice setting. The e-PainSupport application delivers an education module about pain management to patients and caregivers, expedites pain reporting to nurses, and facilitates adherence to pain management. The overall goal of the e-PainSupport application is to improve pain management and reduce patient pain intensity in the home hospice setting.

Conditions

Pain

Keywords

Pain, Pain management, Analgesics, Adherence; Hospice, End-of-Life Care; Caregiver; m-Health, digital interventions

Outcome Measures

Primary Outcomes (3)

• Minimally Important Clinical Change in Worst Pain Intensity

  At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: Worst pain and average pain in past 7 days scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.

  Baseline to 2-weeks post baseline

• Minimally Important Clinical Change in Average Pain Intensity

  At Least 20 Percent Change on the PROMIS Average Pain Scale. Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: Average pain in past 7 days, and current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain, summed for a range of 3 to 15. Higher scores indicates higher pain intensity.

  Baseline to 2-weeks post baseline

• Minimally Important Clinical Change in Current Pain Intensity

  At least 20 percent change on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-Short Form 3a v1.0: 3 items: current pain, scored from 1 = no pain, 2= mild, 3 = moderate, 4= severe, 5 = very severe pain. Higher scores indicates higher pain intensity.

  Baseline to 2-weeks post baseline

Secondary Outcomes (1)

• Change in the Continuous Score of the Pain Intensity Scale

  Baseline to 2-weeks post baseline

Other Outcomes (3)

• Caregiver Self-efficacy: Difference in Self-efficacy Scores From Baseline to 14 Days

  Baseline to 2-weeks post baseline

• Adherence to Pain Management: Difference in Change Scores From Baseline to 14 Days

  Baseline to 2-weeks post baseline

• Family Caregiver Knowledge: Difference in Change Scores From Baseline to 14 Days

  Baseline to 2-weeks post baseline

Study Arms (2)

e-PainSupport Condition

EXPERIMENTAL

e-PainSupport is a self-administered, digital pain application. Over the course of the two weeks, caregivers and patients will record the severity of patient's pain and how much pain medicine they use to control patient's pain in the e-PainSupport application.

Behavioral: e-PainSupport

Standard Care Condition

NO INTERVENTION

Patients and caregivers will be given a paper copy of the same list of resources for pain management included in the Education Module of the e-PainSupport condition at baseline.

Interventions

e-PainSupport BEHAVIORAL

Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.

e-PainSupport Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prior enrollment of their hospice nurse
• receives analgesics for pain
• speaks and reads English
• age 18 or older
• has a primary informal caregiver who is available for the 2 weeks of the study
• expected survival of at least 2 weeks
• can verbalize pain.
• speaks and reads English
• age 18 or older
• cares for an enrolled patient
• available for the 2 weeks of the study.
• registered nurse (RN)
• provides direct care to patients
• has not had a prior patient enrolled in the study

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

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  PMID: 17363323 RESULT

• Mayahara M, Wilbur J, Fogg L, Paice JA, Miller AM. e-PainSupport: A Digital Pain Management Application for Home Hospice Care. Am J Hosp Palliat Care. 2024 Oct;41(10):1120-1126. doi: 10.1177/10499091231211493. Epub 2023 Oct 28.

  PMID: 37897444 RESULT

• Mayahara M, Wilbur J, Fogg L, Houlihan MC, Oliver DP, Benson JJ, Miller AM. The e-PainSupport Digital Application for Assessing Pain and Pain Management in Home Hospice: A Randomized Controlled Trial. West J Nurs Res. 2025 Aug;47(8):708-719. doi: 10.1177/01939459251338392. Epub 2025 Jun 10.

  PMID: 40495339 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Masako Mayahara
• Organization: Washington University in St. Louis

masakom@wustl.edu

847-738-0951

Study Officials

• Masako Mayahara, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Collectors will be blinded to the intervention. Study participants will be asked to not disclose their treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: May 3, 2021
• Study Start: April 21, 2021
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)