NCT03430960

Brief Summary

  • Purpose The general purpose of this project is to assess the utility of the mCare application and MHCE (Mobile Healthcare Environment) system - a secure, mobile, smartphone app based platform - for same day surgery postoperative follow up of patients receiving peripheral nerve blocks.
  • Research Design Randomized open-label study, comparing the satisfaction of the two groups with the method of follow up, which is either over the phone or via a mCare application. A separate group made up of nurses and physicians will have the opportunity to take a short anonymous survey to rank their opinion on the use of the smartphone application for patient feedback.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

November 28, 2017

Last Update Submit

September 18, 2018

Conditions

Pain

Keywords

mCarepost surgerymobilehealthcareapplication

Outcome Measures

Primary Outcomes (1)

  • Clinical Burden of Contact Method

    This will be measured by comparing the proportion of patients who completed clinical measures at initial contact attempt and any contact attempt. The initial contact method is a phone call for the SOC group, and an initial text reminder for mCare group. Patients who do not respond to the initial contact attempt are subsequently re-contacted, which is a clinical burden.

    10 days

Secondary Outcomes (2)

  • Participant-Reported Contact-Method Evaluations

    10 days

  • Nurse Satisfaction and Preferences

    10 days

Study Arms (2)

Group A - Standard of Care

OTHER
Other: Phone Call

Group B - mCare group

EXPERIMENTAL
Other: Mobile App Survey

Interventions

Phone CallOTHER

Participants will be followed-up via phone call by Acute Pain Research Nurse

Group A - Standard of Care
Mobile App SurveyOTHER

Participants will be followed-up via mCare mobile app

Group B - mCare group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female military health care beneficiaries age 18 and 89 years old
  • Receive peripheral nerve block affecting their limb(s)
  • Same day surgery
  • Owns a personal cell phone with the following features:
  • A 320 x 240 screen display resolution or greater
  • ii. Text messaging capabilities
  • iii. Data service capabilities
  • iv. Service provided by either: AT\&T, AllTel, Sprint, T-Mobile, or Verizon
  • Ability to use their personal cell phone
  • Ability to read and respond to a message in English as the app is only in English.
  • Receives reliable cell phone service in their home.
  • DEERS eligibility

You may not qualify if:

  • Under age 18 and over 89 years old
  • Non-English speaking-App will only be in English as this is an app developed just for this study.
  • Active participation in other research studies involving mobile devices
  • Inability to interact with a touch screen mobile device
  • Receive Exparel(which is a pain medication drug they can receive during surgery since these patients will be called 48 hour post discharge)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • COL (ret) Chester C Buckenmaier, MD

    Defense and Veterans Center for Integrative Pain Management

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2017

First Posted

February 13, 2018

Study Start

June 16, 2016

Primary Completion

June 15, 2018

Study Completion

August 30, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

US(1)