Patient-Empowered Mobile Technology in Hospitalized Patients (TRU-PAIN)

NCT02895841 | Completed DMC

• 1 other identifier: Pro00068979
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about the ways in which mobile technology can be integrated into inpatient care to help better track pain levels using mobile technology of patients with sickle cell disease, oncology patients, and bone marrow transplant patients. The study will assess whether or not daily mobile monitoring with wearable accelerometers (devices that detect movement as well as heart-rate) to monitor and manage medical treatments can have a lasting positive impact on outcomes in patients with chronic diseases. The investigator hopes to learn more about the ways in which mobile technology can be integrated into inpatient care. Specifically, the investigator is looking to help patients better track their pain, use wearable technology to track physiological measures (for example, heart rate, sleep quantity and quality), and integrate these data points into the medical care of patients by providing the information to providers. This study will first gather information regarding the feasibility and acceptability of the use of technology on the inpatient unit. This will help the study team to refine the technology of the mobile app and logistics of integration. Following this, the investigator will complete a second phase of the study, during which select patients will pilot the intervention. This will be followed by the third and final phase, during which patients will be randomly assigned to the active intervention or standard of care. This phase approach will enable the study team to refine the intervention, relying on the feedback from patients and providers, and subsequently test its utility compared to standard of care through random assignment.

Conditions

Pain

Keywords

oncology; bone marrow transplant; sickle cell disease

Outcome Measures

Primary Outcomes (1)

• time to discontinuation of the IV PCA with opioid medication

  7 days

Secondary Outcomes (3)

• time of movement during hospitalization

  7 days

• magnitude of change in pain scores

  7 days

• patient/family satisfaction scores as measured by feasibility survey

  7 days

Study Arms (2)

Standard of Care

NO INTERVENTION

Patients will continue with their normal Standard of Care for their condition

SMART app wearable device

EXPERIMENTAL

Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a "wearable device" will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths').

Other: SMART app wearable

Interventions

SMART app wearable OTHER

Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a "wearable device" will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths').

SMART app wearable device

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient 8-80 years old with a past medical history for a chronic disease (such as sickle cell disease), cancer (solid tumor, lymphoma, brain tumor), or currently undergoing bone marrow transplant
• Currently admitted to the hospital
• Have a current diagnosis which includes pain for which they are being treated

You may not qualify if:

• Must be enrolled within 48 hours of admission
• Due to the possibility of a choking hazard, only patients who are at least 8 years of age will be enrolled in the study
• Patients in the Intensive Care Units will not be eligible
• Must be able to understand and operate the mobile device independently; therefore the investigators will exclude those the provider team considers unable to do so

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Vaughn J, Gollarahalli S, Shaw RJ, Docherty S, Yang Q, Malhotra C, Summers-Goeckerman E, Shah N. Mobile Health Technology for Pediatric Symptom Monitoring: A Feasibility Study. Nurs Res. 2020 Mar/Apr;69(2):142-148. doi: 10.1097/NNR.0000000000000403.

  PMID: 31972852 DERIVED

MeSH Terms

Conditions

Pain; Neoplasms; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nirmish Shah

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)