Text Message Study

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT01789697
Collaborator
(none)
18
1
2
17.9
1

Study Details

Study Description

Brief Summary

The objectives of this double-blind, randomized, controlled study are to evaluate the efficacy of maintaining contact with low-back pain patients through text messaging and emailing, to decrease anxiety levels, pain, number of follow-up visits through text messaging and emailing, and to improve reporting of surgical site infection after spine surgery through text messaging and emailing. The outcomes that will be measured are anxiety, pain, follow-up visits and received phone calls, and reporting signs of surgical site infection. Participants will include Dr. Oren Gottfried's patients who underwent spine surgery at Duke Hospital or at Duke Raleigh Hospital. Patients will be approached after determination that the patient is going to undergo spinal surgery. All patients meeting inclusion criteria will be approached to participate irrespective of race or ethnicity. A total of 194 subjects will be recruited.

Condition or Disease Intervention/Treatment Phase
  • Other: cellular device/computers
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Using Mobile Phone Text Messaging and E-mailing to Decrease Anxiety, Pain, Follow-up Visits and Improve Reporting of Surgical Site Infection After Spine Surgery: A Double-Blind Randomized Trial
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Receives text messages/emails

Will receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Other: cellular device/computers
A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.

No Intervention: Does not receive text messages/emails

Will not receive text messages and emails periodically from the surgeon from Day 1 (day after discharge) through day 21.

Outcome Measures

Primary Outcome Measures

  1. Change in Anxiety [Day 1-21, Month 3, Month 12]

    Anxiety is measured by the Zung Self-Rating Anxiety Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.

  2. Change in Pain [Day 1-21, Month 3, Month 12]

    Pain is measured by the VAS Scale, which will be filled out everyday from day 1 (day after discharge) through day 21, and at the 3 month and 12 month mark.

  3. Change in Surgical Site [Day 1-21]

    Changes in the surgical site is measured by a questionnaire, which will be filled out everyday from day 1 (day after discharge) through day 21.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients age greater than 18 years

  • Patients who confirm they have an unlimited text message data plan and email capabilities on their mobile device

  • Patients of Dr. Gottfried's underwent lumbar decompression or fusion surgery

  • Patients with text message capabilities

  • Patients who have an active email account

Exclusion Criteria:
  • Patients who demonstrate an inability to fill out the pre-visit questionnaires

  • Patients with a diagnosis of metastatic disease

  • Patients with workers compensation or liability pending

  • Patients who will require transfer to an acute rehabilitation facility following surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT01789697
Other Study ID Numbers:
  • Pro00034182
First Posted:
Feb 12, 2013
Last Update Posted:
Apr 9, 2018
Last Verified:
Apr 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2018